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

Catalog Number	001388LX9
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
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
It was reported that the ul pro fused headlight cable 9ft (001388lx9) had browning, burnt end fittings.It is unknown under what circumstance this event was discovered; however, no patient injury, death or surgical delay was reported.
Additional Manufacturer Narrative
The ul pro fused headlight cable 9ft, 275cm ((b)(6)) was returned for evaluation.Failure analysis: the ul pro fused headlight cable was received in used condition.A visual check was performed on the headlight cable and inspection identified that the cable had heat damage on the end fitting.Root cause analysis: the reported complaint was confirmed.It was determined that this issue was most likely due to overheating of the lightsource that the cables were connected to.
Event or Problem Description
N/a.

• Brand Name: UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM
• Common Device Name: CABLES
• 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: 18918835
• Report Number: 3006697299-2024-00025
• Device Sequence Number: 15146040
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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: Other
• Device Catalogue Number: 001388LX9
• Device Lot Number: WO193434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/26/2024
• 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