MAUDE Adverse Event Report: STERIS CORPORATION LB83 LIGHT HANDLE COVER

Model Number	LB83
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	03/20/2025
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 recommended instructions for installation of the lb83 light handle cover product is documented within the applicable steris surgical lighting system's operator manual.The relevant operator manual is provided with every steris surgical lighting system sold.The device history record for the subject lot was reviewed and confirmed the lot was manufactured according to specifications, no abnormalities were noted.The device subject of the reported event was not returned for evaluation.A complaint review confirmed this to be an isolated event for the subject lot.No additional issues have been reported.
Event or Problem Description
The distributer reported that their lb83 light handle cover fell into the sterile field during a patient procedure.No report of injury.

• Brand Name: LB83 LIGHT HANDLE COVER
• Common Device Name: LB83 LIGHT HANDLE 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
• MDR Report Key: 21864619
• Report Number: 1043572-2025-00043
• Device Sequence Number: 15414378
• Product Code: FTA
• UDI-Device Identifier: 00724995172572
• UDI-Public: (01)00724995172572(17)260520(10)11044668
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2025

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 Expiration Date: 05/20/2026
• Device Model Number: LB83
• Device Catalogue Number: LB83
• Device Lot Number: (10)11044668
• 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: 03/20/2025
• Initial Report FDA Received Date: 04/18/2025
• 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