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	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event was discarded and not returned for evaluation.As the device is not available for evaluation, a root cause of the reported event cannot be determined.The light handle cover is manufactured and packaged by a third party.Steris notified the third-party that of the issue that was found.The third-party provider confirmed that the product was manufactured according to specification.A review of the event was performed and determined the most probable cause of the malfunction was error within the installation.A complaint review has confirmed this to be an isolated event for the subject lot.No additional issues have been reported.
Event or Problem Description
The distributor reported that during a patient procedure their light handle cover detached and fell into the sterile field causing a procedure 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: 19330348
• Report Number: 1043572-2024-00031
• Device Sequence Number: 3076987
• Product Code: FTA
• UDI-Device Identifier: 00724995150136
• UDI-Public: 00724995150136
• 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
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: 10722935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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