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	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation revealed that the cause of the reported detachment is due to the customer installing the light handle cover on a product that is not marketed for its use.The customer stated that they were in fact using the wrong light handle cover.The user facility was provided the correct light handle cover to be utilized with their surgical lighting systems.No additional issues have been reported.
Event or Problem Description
The user facility reported that their lb53 light handle cover fell off into the sterile field.The procedure was completed successfully following a short delay.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: 19055168
• Report Number: 1043572-2024-00020
• Device Sequence Number: 12597397
• Product Code: FTA
• UDI-Device Identifier: 00724995150136
• UDI-Public: 00724995150136
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/05/2024

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
• 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: 03/07/2024
• Initial Report FDA Received Date: 04/05/2024
• 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