MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM

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	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the light handle assembly detached from their harmonyair a-series lighthead during a procedure.The light handle assembly did not fall as it was connected to and supported by the lighthead wire harness.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and determined that the retaining ring that secures the light handle assembly to the lighthead was not in place resulting in the reported event.The lighthead has been removed from service pending repairs.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
A steris service technician replaced the light head subject of the reported event, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.

• Brand Name: HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM
• Common Device Name: LIGHTING SYSTEM
• 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: 19341209
• Report Number: 1043572-2024-00033
• Device Sequence Number: 17927799
• Product Code: FSY
• UDI-Device Identifier: 00724995189068
• UDI-Public: 00724995189068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/17/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: Not provided; 04/16/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 09/05/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown