MAUDE Adverse Event Report: STERIS CORPORATION LB53 LIGHT HANDLE COVER; LB53 LIGHTHANDLE COVER

Model Number	STERILE LIGHTHANDLE COVER
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	09/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has confirmed the reported issue.The polyblend plastic material that is used to form the light handle cover was sourced from a secondary supplier beginning in october 2022 and may not meet performance specifications.Steris initiated a recall (removal) of the affected product on march 3, 2023.
Event or Problem Description
The user facility reported that during a patient procedure their light handle cover detached and fell.No report of injury.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: LB53 LIGHT HANDLE COVER
• Common Device Name: LB53 LIGHTHANDLE COVER
• Manufacturer (Section D): STERIS CORPORATION; 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: 17962425
• Report Number: 1043572-2023-00151
• Device Sequence Number: 12441220
• Product Code: FTA
• UDI-Device Identifier: 00724995150136
• UDI-Public: (01)00724995150136(17)241205(10)9799097
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2024
• Device Model Number: STERILE LIGHTHANDLE COVER
• Device Catalogue Number: LB53
• Device Lot Number: (10)9799097
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2022
• 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