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

Model Number	001388LX9
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during preparation/inspection before surgery, the ul pro fused headlight cable 9ft (001388lx9) end fitting grew extremely hot and melted part of the sheath down.The cable was reportedly used with integra mlxeu unit, with light intensity of 90%.There was no patient contact; thus, no injury or surgical delay was reported.End user facility: (b)(6) hospital.
Additional Manufacturer Narrative
The ul pro fused headlight cable 9ft (001388lx9) was returned for evaluation: failure analysis: the returned ul pro fused headlight cable was in used condition.A visual/functional check was performed on the cable.Visual inspection identified that the cable was missing the hot surface symbols that are normally present near the end.Functional evaluation identified that the cable functioned as intended and the end fitting did not overheat.Root cause analysis: the reported complaint could not be duplicated.No manufacturing, workmanship, or material deficiency has been identified.The issue of this cable overheating and melting could be due to a malfunctioning 00mlx unit.

• 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: 17159896
• Report Number: 3006697299-2023-00065
• Device Sequence Number: 5577775
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2023

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: 001388LX9
• Device Catalogue Number: 001388LX9
• Device Lot Number: 186442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/19/2023
• 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