MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT 2 BAY SYSTEM - US; PFM05

Model Number	90620US
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the cooling fan on the duo headlight 2 bay system - us (90620us) was not working; the light goes on and off after overheating.It is unknown under what circumstance this even occurred; however, no patient injury or surgical delay was reported.
Additional Manufacturer Narrative
The duo headlight 2 bay system - us (90620us) has been returned for evaluation: failure analysis: the duo headlight was received in used condition.Evaluation of the duo headlight found that the unit failed the light large spot uniformity, the light large spot size and the light quality tests.Thus, the unit will be sent out to the manufacturer for luminaire repair.Additionally, the customer reported that the cooling fan was not working, leading to the light flickering.The unit was received for evaluation without the holster.The service & repair team will advise the customer to replace the unit holster after receiving the unit back from repair, as the holster may be the cause of the problem.Root cause analysis: evaluation identified that the luminaire required repair, the cooling fan was not working, and the holster required repair.Evaluation determined that the failure was most likely due to routine use and wear.The reported complaint was confirmed.No manufacturing, workmanship, or material deficiency has been identified.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - US
• Common Device Name: PFM05
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16957124
• Report Number: 3006697299-2023-00056
• Device Sequence Number: 17871417
• Product Code: FSR
• UDI-Device Identifier: 10381780490746
• UDI-Public: 10381780490746
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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: Other
• Device Model Number: 90620US
• Device Catalogue Number: 90620US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown