- Applied Medical Resources
- Issuing Office:
- Los Angeles District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
Telephone: 949-608-2900 FAX: 949-608-4415
UNITED PARCEL SERVICE
April 10, 2015
WL # 15-15
Mr. Said Hilal, President and CEO
Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688-2650
Dear Mr. Hilal:
During an inspection of your firm located in Rancho Santa Margarita, California on November 03, 2014, to December 16, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm’s medical devices are used in minimally invasive surgery, laparoscopy, cardiovascular/vascular, urologic and general surgery. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC § 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 are intended to affect the structure or function of the body.
This inspection also revealed that your 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 acknowledge your response dated December 30, 2014, 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:
1. Failure to implement procedures for corrective and preventive actions to identify corrective and preventive actions as required by 21 CFR 820.100(a)(3). Specifically, quality data were not adequately analyzed to identify causes of non-conformities and to identify corrective and preventive actions. For example:
Your firm received 94 complaints in 2014 related to the suction/irrigation malfunctions of the blue and red suction/irrigation buttons getting stuck and not turning off. This resulted in continuous suctioning, tissue injury, and/or fluid irrigation.
You received complaints of the blade not returning back to the trocar, trocar breakage, molding defect, and obturator/seal problem.
Your review of these complaints failed to adequately evaluate and investigate the non-conformities. You failed to implement, verify, and validate corrective and preventive actions to address all the deficiencies associated with your device non-conformities. Your response is not adequate.
2. Failure to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications as required by 21 CFR 820.198(c). Specifically, you failed to evaluate and investigate the root cause of a device failure and for the device not meeting its intended use.
Kii Shield Bladed System
Incident (b)(4): the knife did not return back to the trocar and an artery was cut. The Doctor had to open up the patient to stop the bleeding but the patient lost a lot of blood and died a few days later.
Incident (b)(4): iliac artery wound during introduction of the trocar requiring a second surgery and blood transfusion, resulting in a patient death.
Epix Universal Clip
Incident (b)(4): clips on the cystic artery fell off, bleeding occurred, which required an open surgery.
Incident (b)(4): first clip did not come out of applicator with second clip causing tearing of the cystic artery and bleeding.
Incident (b)(4): smoke evacuator stayed in stuck position and sucked up the bowel.
Incident (b)(4): suction did not respond to manual suctioning and continued suctioning resulting in digestive tract superficial injuries.
You failed to adequately evaluate and investigate the complaints in that you did not fully document the test methods used in your evaluations/investigations of the complaints including how the test equipment used replicated clinical conditions at surgery. You did not provide raw data test results from your investigations, determine root cause, or perform trending on the multiple, repeat complaint types. Your response is not adequate.
3. Failure of the design verification and design methods to confirm that design output meets design input requirements as required by 21 CFR 820.30(f). Specifically, design output test results were not verified to meet design inputs.
Kii Shielded Bladed Access System
The design verification reports, DHF No. (b)(4) dated 3/7/08, 3/28/08 and (b)(4) dated 4/18/08 lacked required raw data and reason for the use of a safety factor in calculation of the load force. The design reports dated 2/11/08, 3/7/08 and 3/28/08 lacked the rationale for differences in gamma radiation cycles of study and production samples. You did not explain why the Cap/Obturator Dislodgement acceptance criterion was changed from (b)(4) lb. to (b)(4) lb. Study (b)(4) did not provide justification as to why only half of the samples had recorded data for the Cap/Dislodgement test.
You state in your response that you have updated procedures and provided training to address the lack of certain raw data. However, you did not provide evidence of the procedure change, training, or your opened Corrective Action Report [CAR]. Your response is not adequate.
4. Failure to adequately establish procedures for design input as required by 21 CFR 820.30(c). Specifically, for your design verification reports UBD dated 11/27/12, (b)(4) dated 3/7/08 and 3/28/08 and (b)(4) dated 4/18/08, your test acceptance criteria was not defined in the test protocols and per intended use. You also stated that blade tip damage is acceptable without providing a rationale. Your results for the (b)(4) units were not found to be comparable to the control units but you found the results to be acceptable. You attribute the cap/base dislodgement to user error without evidence.
You state in your response that you will make procedural enhancements and improvements in recording data and statistical methodology. You also note that you opened a CAR. However, your response did not have the procedure or CAR. You also continue to state that blade tip damage during testing is acceptable and user error produced the cap/base dislodgment without evidence and rationale. Your response is not adequate.
5. Failure to validate the design under defined operating conditions as required by 21 CFR 820.30(g). Specifically, the Use by Date for shelf life in the “UBD report 11/12mm Kii Shielded Bladed Access System 3 Years” did not have all of the temperature data for the samples. Our investigator asked for the data during the inspection but it was not provided.
You provided temperature logs with your response and state that you opened a CAR regarding data logging. However, you did not provide the CAR in your response. You also rely on Engineering reports/projects in lieu of having the acceptance criteria in a formalized study protocol. Your response is not adequate.
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within the corrections will be completed.
In addition, FDA has noted nonconformances with section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), which are deficiencies pertaining to the Medical Device MDR Reporting (MDR) Regulation found at Title 21, Code of Federal Regulations (CFR), Part 803. These nonconformances include, but are not limited to, the following:
1. Failure to report to us no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
For example, Complaint #(b)(4), references an event where the patient sustained a small bowel injury that had to be repaired. The serious injury MDR#2027111-2014-00294 was received by FDA after the 30 calendar day timeframe.
We reviewed your firm’s response dated December 30, 2014, and conclude that it appears to be adequate. Your firm justified the late reporting for complaint #(b)(4), corresponding to MDR#2027111-2014-00294. Your firm also described its corrective and preventative action plan for similar situations.
2. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17(a). For example, after reviewing your firm’s MDR Procedure titled “Medical Device Reporting Requirements SOP”: 3-8002, Rev. M, effective date 09/24/13, the following issues were noted:
a. SOP: 3-8002, Rev. M, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example:
i. There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
b. SOP: 3-8002, Rev. M, does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, the following are not addressed:
i. The procedure does not include or refer to instructions for how to obtain and complete the FDA 3500A form.
ii. The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
. If you have any questions about the content of this letter, please contact Dr. Raymond W. Brullo at (949) 608-2918.
Your response should be sent to:
CAPT Daniel Cline, Acting Director
Compliance Branch, Los Angeles District
Food and Drug Administration
Irvine, CA 92612-2506
Alonza E. Cruse, Director
Los Angeles District
David M. Mazzera, Chief, Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413
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