MAUDE Adverse Event Report: STERIS CORPORATION; STERILE LIGHTHANDLE COVER

Model Number	STERILE LIGHTHANDLE COVER
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the description of the reported event, the likely cause of the reported detachment would be attributed to incorrect or incomplete installation of the cover by user facility personnel.The light handle cover was being utilized with a harmonyair a-series surgical lighting system at the time of the reported event.The harmonyair a-series surgical lighting system operator manual includes instructions for installation of a disposable light handle cover within chapter 6 operating instructions: installing disposable light handle cover.Steris offered in-service training to the user facility on the proper use and operation of the lb83 light handle cover specifically, proper installation practices; however, the user facility declined.A complaint review was performed and confirmed this to be an isolated event for the subject lot.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure their light handle cover detached and fell into the sterile field contacting the patient.No report of injury.

• Brand Name: NA
• Common Device Name: STERILE LIGHTHANDLE COVER
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23438809
• Report Number: 1043572-2025-00096
• Device Sequence Number: 20023283
• Product Code: FTA
• UDI-Device Identifier: 00724995172572
• UDI-Public: (01)00724995172572(17)270712(10)11480436
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: STERILE LIGHTHANDLE COVER
• Device Catalogue Number: LB83
• Device Lot Number: (10)11480436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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