• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

Enforcement Actions

Steris Corporation 29-Nov-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New Orleans District
404 BNA Drive, Building 200, Suite 500
Nashville, TN 37217

Telephone: 615-366-7801
FAX: 615-366-7802


November 29, 2006

WARNING LETTER No. 2007-NOL-07

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. Les C. Vinney, Chief Executive Officer and President
Steris Corporation
5960 Heisley Road
Mentor, Ohio 44060

Dear Mr. Vinney:

During an inspection of your firm, located in Montgomery, Alabama, on June 5 - 8, 12 and 13, 2006, investigators from the United States Food and Drug Administration (FDA) determined your firm manufactures sonic energy cleaners. 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 any function of the body.

This inspection revealed your Steris' Amsco® Sonic Energy Cleaners are misbranded under Section 502(t)(2) of the Act, 21 USC 352(t)(2), in which your firm failed or refused to furnish material or information reporting the device under Section 519 of the Act, 21 USC 360i, and Title 21, Code of Federal Regulations, Part 803 (21 CFR 803) - Medical Device Reporting (MDR) regulation. We received a response from [redacted] dated June 30, 2006, concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations issued to [redacted]. We address this response below. These violations include, but are not limited to, the following:

• Failure to submit MDRs to the FDA, for sixteen separate units, as required by 21 CFR 803.50(a)(2). In accordance with 21 CFR 803 .50(a)(2), you must report to us no later than 30 calendar days after the day you receive or otherwise become aware of information, from any source, which reasonably suggests a device you market has malfunctioned and this device or a similar device you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.

For example:

• Complaint number 12588, dated May 25, 2004, documented the malfunction of a Sonic Cleaner manufactured by your firm. The complaint stated a hospital employee observed "Visible flame coming from the right side of the unit at the lid switch actuator opening" of the Sonic Cleaner. The reported model number was 1951373, and the lot number was [redacted].

• Complaint numbers 13952 and 13988, dated August 4, 2004 and August 6, 2004, documented the malfunction of a Sonic Cleaner manufactured by your firm. The complaint described a Sonic Cleaner with interior wires which melted and caught fire. The reported model number was 1951373, and the lot number was [redacted].

• Complaint number 14788, dated September 24, 2004, documented the malfunction of a Sonic Cleaner manufactured by your firm. The complaint described the Sonic Cleaner as "Sparking and smoking" and stated the unit smelled like something had burned. The reported model number was 1951373, and the lot number was [redacted].

• Complaint number 15670, dated November 10, 2004, documented the malfunction of a Sonic Cleaner manufactured by your firm . The complaint described the problem as "Sonic switch is smoking and burning. Can see flames, but can't get to plug to unplug it." The reported model number was 1951373, and the lot number was [redacted].

• Complaint numbers 15828 and 15783, dated November 3, 2004 and November 16, 2004, documented the malfunction of two Sonic Cleaners manufactured by your firm. The complaint stated the "Wiring harness that is above the lid motor is burned/melted." The complaint also stated this was the second unit in which the malfunction occurred. The reported model number was 1951373, and the lot numbers were [redacted] and [redacted].

• Complaint number 16406, dated December 16, 2004, documented the malfunction of a Sonic Cleaner manufactured by your firm. The complaint stated an employee "Smelled a strong burning odor and observed flames shooting out the back of the unit." The reported model number was 1951373, and the lot number was [redacted].

• Complaint number 18886, dated April 13, 2005, documented the malfunction of a Sonic Cleaner manufactured by your firm. The complaint documented "Ultrasonic caught fire, customer believes it was the result of a loose wire." The reported model number was 1951373. No lot number identified in complaint.

• Complaint number 22149, dated September 1, 2004, documented the malfunction of a Sonic Cleaner manufactured by your firm. The complaint documented the "Sonic Cleaner caught fire. No injuries and was under control before the fire department arrived." The reported model number was 1951373, and the lot number was [redacted]

• Complaint numbers 24280 and 24661, dated October 14, 2005 and December 1, 2005, documented the malfunction of a Sonic Cleaner manufactured by your firm. The complaint stated "Unit caught fire and was damaged beyond repair." The reported model number was 1951373, and the lot number was [redacted].

• Complaint number 24314, dated December 1, 2005, documented the malfunction of a Some Cleaner manufactured by your firm. The complaint stated, "Unit caught on fire while not in use. They had to evacuate the facility and two employees suffered smoke inhalation. They were both treated and released." The reported model number was 1951373, and the lot number was [redacted].

• Complaint number 24715, dated December 16, 2005, documented the malfunction of a Sonic Cleaner manufactured by your firm. The complaint stated, "Customer called in stating that the Sonic unit started smoking, they unplugged and called for service." The reported model number was 1951373, and the lot number was [redacted].

• Complaint number 25882, dated February 2, 2006, documented the malfunction of a Sonic Cleaner manufactured by your firm. The complaint stated the wiring harness of the Sonic Cleaner caught on fire and resulted in the lower level of a medical facility having to be evacuated. The reported model number was 1951373, and the lot number was [redacted].

• Complaint number 25962, dated February 7, 2006, documented the malfunction of a Sonic Cleaner manufactured by your firm. The complaint stated the Sonic Cleaner caught on fire and everyone had to evacuate the building. The complaint also documents, "This is the second unit that caught on fire within a year." The reported model number was 1951373, and the lot number was [redacted].

[redacted] response letter states your firm will review procedures and processes relating to complaint administration and Medical Device Reporting [redacted] response also states a comprehensive review of complaints received since November 2000 would be conducted to identify any additional instances requiring reporting. We will evaluate the adequacy of this response during the next FDA inspection of your facility.

We acknowledge receipt of correspondence from [redacted] dated August 3, 2006, stating your firm identified complaint number 25359 as not being a Steris device and the Steris' service technician noted no evidence of fire within the device on January 17, 2006. 21 CFR 803.22(b)(2) states when you receive reportable event information in error, you must forward this information to us with a cover letter explaining you did not manufacture or import the device in question. We also acknowledge receipt of correspondence from [redacted] dated August 22, 2006, stating your firm identified five additional complaints beyond those noted during the recent inspection.

Our inspection also revealed your Steris' Amsco® Sonic Energy Cleaners are misbranded under Section 502(t)(2) of the Act, 21 USC 352(t)(2), in which your firm failed or refused to furnish material or information reporting the device is required by or under Section 519 of the Act, 21 USC 360i, and 21 CFR Part 806 - Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:

• Failure to submit a written report to FDA when you initiated a correction to the Steris' Amsco® Sonic Energy Cleaners in response to complaints of fires associated with the units, as required by 21 CFR 806.10. In January 2005, a change to the manufacturing of the Sonic Cleaner. was made by your firm, as part of Engineering Change Authorization 054160 in response to your investigation into the complaints discussed above. On June 3, 2005, a Steris Service Tip [MG 1 C -STERIS Service Tips Number 05022-SST (Sonic Energy Systems - Inspection of Lid Switch Wiring)] was issued to your service personnel advising them to inspect the lid switch wiring in the Sonic Energy Console and Cleaner at the next Preventive Maintenance Inspection and make corrections as required of the Sonic Cleaner not having a Preventive Maintenance agreement.

FDA regulations require manufacturers and importers to promptly report to FDA any correction or removal of a device if the correction or removal was initiated to reduce a risk to health. Since your firm's actions described above meet the definition of a "correction" in 21 CFR 806.2(d), and because they were initiated to reduce a risk to health, your failure to report them violated 21 CFR 806.10(a)(1).

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 FDA 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 they may take this information into account when considering the award of contracts.

Please notify this office in writing within fifteen (15) working days from the date you receive 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 action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: U.S. Food and Drug Administration, Attention: Kari L. Batey at the address above. If you have any questions about the content of this letter, please contact Ms. Batey at (615) 366-7808.

Finally, you should know this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely,

/S/

H. Tyler Thornburg
District Director
New Orleans District

Enclosure: Form FDA 483

cc:
Steris Corporation
2720 Gunter Park Drive East
Montgomery, Alabama 36109-1410