MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM; LIGHTING

Catalog Number	001388LX9
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that during an ear, nose, and throat (ent) procedure, the ul pro fused headlight cable 9ft, 275 cm (001388lx9) black rubber or the plastic melted.Approximately 20 minutes into the procedure, the headlight shut off, with the cord being described as hot or melting.There was no patient injury, death, or surgical delay reported.
Additional Manufacturer Narrative
Updated fields.B5, d4 (product serial and product lot numbers), d9, g3, g6, h2, h3, h6, h11.The ul pro fused headlight cable 9ft, 275cm (001388lx9) was returned for an evaluation: the device history record (dhr) was not reviewed, and no manufacturing defects were discovered during failure analysis.Failure analysis: the 001388lx9 ul pro fused headlight cable was returned and evaluated.The headlight cable had visible damage and burn marks at the proximal end of the cable where it is connected to the 00mlx lightsource.The proximal end bezel is cracked with visible burn marks on the ends of the fiber optic strands.Root cause analysis: the complaint is confirmed.The headlight cable had damage, likely caused by overheating to the proximal end of the cable.The most likely cause is physical damage (mishandling/environmental damage) to the 00mlx lightsource displacing internal components that allowed excessive heat from the xenon lamp to damage the headlight cable.
Event or Problem Description
This is 1 of 2 reports for the 1st device reportedly used during this event.This report is linked to mfg# 3006697299-2026-00015.

• Brand Name: UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM
• Common Device Name: LIGHTING
• 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: 23934205
• Report Number: 3006697299-2025-00139
• Device Sequence Number: 14887790
• Product Code: FST
• UDI-Device Identifier: 10381780168034
• UDI-Public: 10381780168034
• Combination Product (Y/N): N
• PMA/510(K) Number: K864380
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 001388LX9
• Device Lot Number: W0204039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 03/03/2026
• 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