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

Model Number	001388LX9
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the light cable attachment part of the ul pro fused headlight cable 9ft (001388lx9) had melted after the operation.No surgical delay or adverse consequences to the patient were observed.
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
N/a.
Additional Manufacturer Narrative
001388lx9 ul pro fused headlight cable was returned for evaluation: device history record (dhr): the dhr was reviewed and showed no abnormalities related to the reported issue.Failure analysis: the returned 001388lx9 cable is in used condition with the rubber end fitting melted due to heat exposure.Light could not pass through the cable when used with a 00mlx light source, indicating internal damage/melting of the lens.This issue may be the result of damage to the 00mlx's heat shield, or exposure to high intensity for long periods of time.Per the ifu, "it is strongly recommended that the light be used at the minimum intensity for good visualization." conclusion: the reported complaint is confirmed.The returned 001388lx9 cable is in used condition with melting damage due to heat exposure.Excessive heat may have resulted from a damaged heat shield or prolonged exposure to high intensity.No manufacturing, workmanship or material deficiency has been identified.

• 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: 13018893
• Report Number: 3006697299-2021-00068
• Device Sequence Number: 4835159
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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 Model Number: 001388LX9
• Device Catalogue Number: 001388LX9
• Device Lot Number: WO175032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/25/2022
• 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