MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY LB83 LIGHT HANDLE COVER

Model Number	LB83
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	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is likely that the reported events are attributed to user error as the light handle covers may have not been properly installed to the surgical light.The harmonyair a-series surgical lighting system operator manual states, (6) "warning-possible patient injury hazard: failure to engage the light handle cover completely may result in cover falling from lighthead during procedure." a steris account manager counseled user facility personnel on the proper method of attaching the light handle covers to the surgical light.There have been no other complaints associated with this lot.No additional issues have been reported.
Event or Problem Description
The user facility reported that during patient procedures their light handle covers detached and fell into the sterile field.The sterile fields were re-established, and the procedures were completed successfully.No report of injury.

• Brand Name: LB83 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 ; 4403927453
• MDR Report Key: 16321154
• Report Number: 1043572-2023-00011
• Device Sequence Number: 18288352
• Product Code: FTA
• UDI-Device Identifier: 00724995172572
• UDI-Public: 00724995172572
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/07/2023

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 Model Number: LB83
• Device Catalogue Number: LB83
• Device Lot Number: 9879022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 02/08/2023
• Date Device Manufactured: 11/08/2022
• 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