MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY LB53 LIGHT HANDLE COVER

Model Number	Sterile Lighthandle Cover
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event was discarded and not returned for evaluation.As the device is not available for evaluation, a root cause of the reported event cannot be determined.The light handle cover is manufactured and packaged in a controlled environment.Employees wear hairnets, safety glasses, gloves, and are fully gowned.Additionally, the light handle cover is terminally sterilized using ethylene oxide.The entire light handle cover device including the contents within the sterile barrier are considered sterile.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our policies and procedures.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch (b)(4)t hat when a lb53 light handle cover was opened, it was noticed that several black flecks were on the light handle cover.The light handle cover was not utilized and was discarded.The user facility utilized another lb53 light handle cover and no issues were noted.No report of injury.

• Brand Name: LB53 LIGHT HANDLE COVER
• Common Device Name: LIGHT HANDLE COVER
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16696860
• Report Number: 1043572-2023-00084
• Device Sequence Number: 17063156
• Product Code: FTA
• UDI-Device Identifier: 00724995150136
• UDI-Public: 00724995150136
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Sterile Lighthandle Cover
• Device Catalogue Number: LB53
• Device Lot Number: 9892111
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown