MAUDE Adverse Event Report: STERIS CORPORATION; STERILE LIGHTHANDLE COVER

Model Number	STERILE LIGHTHANDLE COVER
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that there was no patient or procedure involvement subject of the reported event.The steris lb53 lighthandle covers are sterilized consumables (disposable, single-use only) that are used to drape the lighthandle for the purpose of maintaining a sterile surgical environment.The lighthandle cover is manufactured and packaged in a controlled environment.Employees wear hair nets, safety glasses, gloves, and are fully gowned.The lighthandle cover is terminally sterilized using ethylene oxide.The entire lighthandle 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 procedures and policies.A complaint review has considered the reported event to be isolated for the subject lot.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch # (b)(4) that a hair was found in the lighthandle cover.No report of injury.

• Brand Name: NA
• Common Device Name: STERILE LIGHTHANDLE COVER
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 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: 24590982
• Report Number: 1043572-2026-00025
• Device Sequence Number: 9531549
• Product Code: FTA
• UDI-Device Identifier: 00724995150136
• UDI-Public: (01)00724995150136(17)270522(10)11408494
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/12/2026

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: LB53
• Device Lot Number: (10)11408494
• 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: 02/10/2026
• Initial Report FDA Received Date: 03/13/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown