MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT AND CARRYING CASE; PFM05

Catalog Number	90600
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during surgery, the duo headlight and carrying case (90600) was overheating on the doctor's head, and the plastic had melted.It was also reported that the button for changing the light snob does not work.The were no reports of injuries, death, or surgical delays as another "led duo" was used to complete the surgery.It was noted that the surgeon was not burned because the physician removed the device promptly.
Additional Manufacturer Narrative
The duo headlight and carrying case (90600) was returned for evaluation: the device history record (dhr) could not be completed due to no lot number or serial number being provided.Failure analysis: the duo headlight and carrying case was received in used condition.This issue is not due to overheating, but rather to the improper use of the plastic cap.It is possible that the plastic cap was placed on the luminaire light while the device was already on, causing the cap to melt.The iris adjusting wheel has come loose from the luminaire, and the light field of the luminaire is hazy and has an out-of-spec brightness, which is considered misuse.The luminaire must be replaced.The connector board must be replaced as part of the luminaire replacement.The device must be checked to verify that it meets the manufacturer's specifications.Root cause analysis: the reported complaint was not confirmed.The evaluation did identify that the plastic cap had melted.This occurred because the cap was placed on the headlight while it was on.

• Brand Name: DUO HEADLIGHT AND CARRYING CASE
• 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 08540 ; 6099362319
• MDR Report Key: 22992997
• Report Number: 3006697299-2025-00108
• Device Sequence Number: 15725917
• Product Code: FSR
• UDI-Device Identifier: 10381780491064
• UDI-Public: 10381780491064
• Combination Product (Y/N): N
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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 Catalogue Number: 90600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/08/2025
• 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