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

Model Number	LB53
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	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lb53 light handle cover subject of the reported event unit was discarded and replaced with a new unit.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 lb53 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.Steris offered in-service training to the user facility on the proper use and operation of the lb53 light handle cover specifically, proper installation practices; however, the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure their lb53 light handle cover detached and fell into the sterile field.The procedure was completed successfully.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
• MDR Report Key: 19560070
• Report Number: 1043572-2024-00042
• Device Sequence Number: 4851628
• 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): 06/18/2024

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: LB53
• Device Catalogue Number: LB53
• Device Lot Number: 10925862
• 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: 05/24/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• 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