MAUDE Adverse Event Report: STERIS CORPORATION; LIGHTHANDLE COVER

Lot Number	10990858
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	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported that two of the lb51 lighthandle covers detached and fell into the sterile field during a patient procedure.User facility personnel re-established the sterile field resulting in a procedure delay.No report of injury.
Additional Manufacturer Narrative
Cardinal health medical products and services is the distributor of the lb51 lighthandle covers subject of the reported event.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.Steris advised cardinal health to counsel user facility personnel on the proper installation instructions for the lighthandle covers.A 3-year complaint review was performed for the device and confirmed this to be an isolated event for the subject lot.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: 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
• MDR Report Key: 21766836
• Report Number: 1043572-2025-00033
• Device Sequence Number: 8490594
• Product Code: MDM
• UDI-Device Identifier: 50724995156386
• UDI-Public: 50724995156386
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/03/2025

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 Lot Number: 10990858
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 04/03/2025
• 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