Stingray Surgical Products, LLC 5/3/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
May 3, 2012
Mark T. McBrinn
Stingray Surgical Products, LLC
156 Northwest 16th Street
Boca Raton, Florida 33432
Dear Mr. McBrinn:
During an inspection of your firm located in Boca Raton, Florida, on November 30, 2011, through December 5, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Electrosurgical Forceps. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received your response, dated December 22, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
- Failure to adequately ensure,when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, your firm failed to validate several processes. Specifically:
a) Your firm's validation of its coating process is inadequate in that it failed to demonstrate consistency of the coating process because it only included one device, it only tested the coating integrity and not coating adhesion or thickness, and it failed to document any parameters used for the coating process. Coatings are used on your firm's electrosurgical forceps to protect from potential burns (electric current).
b) During the inspection, you indicated that your firm:
- lacks validation of the (b)(4) welding process,
- lacks validation of the (b)(4) process for cap application, and
- lacks validation of the Ethylene Oxide (EO) and steam sterilization cycle listed in your firm’s current Instructions for Use.
We reviewed your firm’s response and conclude that it is not adequate. Your firm anticipates having the following validation processes completed by March 15, 2012:
- Validation Protocol: (b)(4) Coating Process
- Validation Protocol: Welding Process S02-XXX and S03-XXX
- Validation Protocol: Epoxy Process S02-XXX and S03-XXX
- Steam Sterilization Efficacy Study Reusable Device - 132° C Pre-Vacuum Cycle
Although your firm submitted a copy of the validation procedures listed above, your firm did not indicate why these processes were not validated and whether your firm has implemented a corrective action to ensure that this does not recur. Also, your firm did not indicate whether it has reviewed other processes requiring validation to ensure that they were validated as part of a systemic corrective action.
Your firm also stated that it “will immediately remove the recommendation for EO sterilization from the instructions for use for the reusable instrument.” However, your firm did not provide documentation demonstrating evidence of this implementation.
Your firm has also revised Manufacturing Procedures Insulated for Forceps (QW7.5.4A R02), dated December 30, 2011, for the coating of the forceps. However your firm did not indicate or provide documented evidence that employees received training on the revised procedure.
- Failure to establish and maintain adequate procedures for changes to a specification, method, process, or procedure. Such changes shall be verified or, where appropriate, validated according to 21 CFR 820.75, as required as required by 21 CFR 820.70(b). For example, a batch of your firm's Corvel Black coating (Batch #0004121294), used in the manufacture of electrosurgical forceps, was observed to have expired, but was still in use. Your firm's management stated that, in January 2009 and January 2011, testing was completed to recertify the shelf life of this (b)(4) coating for an additional 2 years by coating (b)(4) reusable forcep, sterilizing it (b)(4) times in an autoclave on site, and completing dielectric tests. However, your firm lacked reasoning why this procedure substantiates an extension of the expiration date for an additional 2 years. It also lacked documentation of a specific coating process used, sterilized cycles performed, or results of the dielectric test other than a document stating that dates passed were January 9, 2009, and January 10, 2011. Your firm, therefore, failed to document validation of the process change for extending the shelf life of the Corvel Black coating.
In addition, the procedure, (b)(4), failed to include a sampling plan that was statistically based and failed to document approval of the results and activities. The procedure cites only a single sample.
We reviewed your firm’s response and conclude that it is not adequate. Your firm states that it will use Validation Protocol: (b)(4) Coating Process to test the expired coating and provide documented evidence to extend and validate the shelf life of expired and pre-expired (b)(4) powder coating. However, your firm’s response did not include the test results of the expired material using its procedure or a valid scientific justification to support its method (Validation Protocol: (b)(4) Coating Process) to analyze the non‑conductive coating material. Additionally, your firm did not provide evidence that a correction and corrective action (including conducting appropriate validation for the process change of extending the shelf life of the raw material and reviewing validation for extension of shelf life for other materials) was implemented or that a systemic corrective action was considered.
- Failure to establish and maintain adequate process control procedures that describe any process controls necessary to ensure conformance to specifications where deviations from device specifications could occur as a result of the manufacturing process, as required by 21 CFR 820.70(a).
Specifically, your firm failed to include documentation on the use of a (b)(4) in the Manufacture Procedures Insulated Forceps (QW7.5.4A Rev 1, dated January 14, 2009). During the inspection, your firm also indicated that that the forcep blanks were (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a revised copy of Manufacturing Procedures Insulated for Forceps (QW7.5.4A R02) which included the use of the (b)(4) as well as the parameters used for the (b)(4). However, your firm did not provide evidence that a corrective action was implemented or that a systemic corrective action was considered, including review of other production processes, to ensure that all activities being performed were documented and completed according to your firm’s procedure.
- Failure to establish and maintain adequate procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Specifically, during the inspection you indicated that your firm failed to complete receiving inspection activities for Corvel Black (Batch # 0004121294) and Corvel Blue (Batch # 0006362168) coatings per its Receiving Inspection Procedure (QW 8.2.1A Rev 1, dated January 14, 2009). You also stated that the plastic bags observed by the investigator in the metal cabinet in the coating process area with no identification on them were Corvel Blue and Corvel Black. According to your firm’s Receiving Inspection Procedure, if raw material passes, a green acceptance sticker would be affixed and the product would be transferred to stock. However, these products had no identification on them.
We reviewed your firm’s response and conclude that it is not adequate. Although, your firm has completed and submitted a Receiving Inspection Form for the Corvel Black and Corvel Blue coating batches noted above, your firm did not indicate that it has reviewed all received products to ensure that they were received according to your firm’s Receiving Inspection Procedure.
- Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, during the inspection, you indicated that your firm failed to document any purchasing controls concerning suppliers of coating Corvel Black and Corvel Blue, according to its Purchasing Procedure (QP7.4A Rev 1, dated January 14, 2009) or any other procedure.
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that this problem occurred because it did not have a proper reference to these purchased materials in its system and that it has corrected this by creating engineering drawings (specifications) and incoming inspection forms for the Corvel Blue and Corvel Black coatings. Although your firm has provided records demonstrating that it has initiated the supplier Self‑Assessment and Quality Agreement, your firm did not provide any additional evidence or documentation showing that the Supplier Self‑Assessment and Quality Agreement has been completed by the coating supplier, (b)(4). Additionally, your firm did not provide evidence that a corrective action was implemented or that a systemic corrective action was considered, including review of all of the suppliers of other purchased products, to ensure it has controls over those suppliers as well.
- Failure to review and evaluate all complaints to determine whether an investigation is necessary and failure to maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate when no investigation is made, as required by 21 CFR 820.198(b). For example, your firm failed to document investigations for Complaint #s 09004, 09-015, and 09-016 on form QF 8.5.4A, Complaint Investigation form. Additionally, the quality manager did not record the reason why no investigation was being made on form QF8.5.3A, as required in the firm’s Customer Complaints Procedure (QP8.5.1A, Rev 01, dated January 14, 2009). Specifically,
a) Complaint #09-004, dated October 28, 2009, references coating (insulation) cracking on Bipolar Cushing Bay Reusable Electrosurgical Forceps near distal end in the spring tension area due to either physical damage or over heating during the sterilization process, for example, over 20 autoclaves.
b) A complaint dated December 8, 2010, which Ms. McBrinn said was Complaint # 09-015, even though it is not documented as such, references that there is a break down of the guide pin area insulation (coating) in a Bipolar Yasargil Reusable Electrosurgical Forceps. The description of the complaint indicates that the product is past one-year warranty (purchased on April 17, 2009) and the break down of the guide pin area insulation (coating) in the Bipolar Yasargil Reusable Electrosurgical Forceps can be due to over 30 autoclaves or more, dropped on hard surface, or even caught in the sterilizing tray, since tips were worn.
c) Complaint # 09-016, dated December 8, 2010, references bent tip on a Bipolar Sco-ville Green Reusable Electrosurgical Forceps. The description of the complaint indicates that the forceps were caught in the sterilizing tray or abused in some way that bent the tip.
Your firm’s response does not address this violation since it was not included as an observation on the FDA 483 issued to your firm.
- Failure to establish adequate procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm’s procedures for quality audits, Internal Audits Procedure (QP8.2.2A Rev 1, dated January 14, 2009), requires all quality procedures to be audited at least once per year and the Quality Manager to annually prepare an audit schedule. Your firm’s representative, Ms. McBrinn, indicated that no audit scheduled had been prepared as required. In addition, your firm's audit criteria do not include auditing of process validation.
We reviewed your firm’s response and conclude that it is not adequate. Your firm has modified its Internal Audit Procedure and has provided a copy of the Audit Schedule with the effective date as December 30, 2011. The audit schedule covers all the regulatory systems including Process Validation. However, it does not include identification of the specific quality procedures to be audited. Additionally, your firm did not provide evidence that a corrective action (including review of all auditing requirements to ensure that they were completed as required) was implemented or that a systemic corrective action was considered.
Our inspection also revealed that your firm’s Electrosurgical Forceps devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR). Significant violations include, but are not limited to, the following:
Failure to adequately develop, maintain and implement a written MDR Procedure, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure, entitled Stingray Surgical Products QW8.5.1A, Mandatory Problem Reporting, Revision 01, Effective date January 14, 2009, the following deficiencies were noted:
a) QW8.5.1A does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, there are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
b) QW8.5.1A does not establish internal systems that provide for a standardized review process or procedure for determining when an event meets the criteria for reporting. For example, While Section V, Procedure, Step 1, includes definitions for the terms serious injury and reportable malfunction, the description of what your firm will consider to be a reportable event is not adequate to ensure that reportable events will not be missed. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on Part 803.3 for the terms become aware and caused or contribute, as well as definitions for the terms reasonably known, found in 21 CFR 803.50(b),and reasonably suggests, found in 21 CFR 803.20(c)(1).
c) QW8.5.1A does not establish internal systems that provide for timely submission of complete medical device reports. For example, Section V, Step 3, of your firm’s MDR procedure refers the Quality Manager to the following FDA web page: http://www.fda.gov/cdrh/mdr/
,stating that the use of the link will provide “
instructions for reporting using the forms specified (note: the information will provide links to the required forms). Ensure that the reporting occurs within the timeframes specified by FDA.”
The above instructions included in your firm’s MDR procedure for reporting events to FDA are incomplete. For example:
- The instructions for navigating the referenced web link will not take the user to the page that details the timeframes for submission of MDRs to FDA.
- The instructions for navigating the referenced web link will not take the user to the required 3500A form and instructions for completing the form.
d) The procedure fails to describe how your firm will address documentation and record-keeping requirements including:
- Documentation of adverse event related information maintained as MDR event files;
- Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable; and
- A process to permit any authorized FDA employee to access records.
Your firm’s response does not address this violation since it was not included as an observation on the FDA 483 issued to your firm.
A review of our records shows that the Electrosurgical Forceps were cleared under K083162, with the following indications for use:
“Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.”
Additionally, our records indicate that the cleared instructions for use are only for a “gravity displacement steam sterilization cycle.” However your firm’s current sterilization instructions for use state the following:
1. Sterilization of bipolar forceps may be accomplished by steam or ethylene oxide (EtO) gas.
2. STINGRAY SURGICAL PRODUCTS, does not recommend the bipolar forceps be sterilized by Flash or Chemical Sterilization.
3. Surgical instruments may also be placed within a rigid sterilization container for processing under generally accepted hospital in-use conditions.
4. The stylus for Irrigation forceps should not be placed in the forceps but can be autoclaved separately.
The recommended sterilization parameters are as follows:
|Sterilization method: ||Temp: ||Wrapped||Container System|
|Pre-Vacuum ||270-275F ||4 Minutes||4 Minutes |
|Gravity ||250-254F ||15 Minutes ||40 Minutes |
| ||270-275F ||10 Minutes ||30 Minutes|
|Ethylene Oxide (EtO) ||125-130F |
105 Minutes with 12% Eto-88%
FREON; 45-75% chamber humidity, aeration of 6 hours.”
These instructions are different from the cleared instructions for sterilization in the following ways:
- The cleared instructions are for a “gravity-displacement steam sterilization cycle” for “wrapped instruments,” while the “current” instructions are for three different sterilization methodologies. The three methodologies include “gravity-displacement steam sterilization cycle,” “dynamic-air-removal stem sterilization cycle,” and sterilization by “Ethylene Oxide (EtO) gas.”
- The current instruction for sterilization recommends use of “rigid sterilization container systems” and states sterilization parameters for using such systems. This recommendation is absent from the cleared instructions. Additionally, the recommended parameters are unconventional in regards to the very long exposure times (40 and 30 min. at 250-254°F and 270-275°F respectively) and such exposure times may damage the instruments.
- The "current" instruction for sterilization recommends use of EtO gas while such recommendation is absent from the "cleared" instructions. EtO gas sterilization raises safety issues in regards to the EtO sterilization residuals on medical devices.
Additionally, the cleared instructions appropriately describes a “dry/cool off cycle” as an integral part of the “gravity-displacement steam sterilization cycle,” while such instructions are missing from the current instruction for use. This renders the process incomplete and risks inadequate sterilization.
Changes in the method of sterilization have the potential for changing performance characteristics of a device and require a new 510(k). Therefore, the Electrosurgical Forceps are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The Electrosurgical Forceps are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(i).
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.
The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: FDA’s Florida District Office, Attn: Salvatore N. Randazzo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. Refer to the Unique Identification Number (CMS 273796) when replying. If you have any questions about the content of this letter please contact Mr. Randazzo - Compliance Officer, by telephone at (407) 475-4712 or via fax at (407) 475-4769.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Emma R. Singleton
Director, Florida District