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

Model Number	001388LX9
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that upon first use, the customer plugged the ul pro fused headlight cable 9ft (001388lx9) into the light source and a loud ¿pop¿ was heard.Following the pop, smoke began to rise from the cable.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.
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.
Additional Manufacturer Narrative
The ul pro fused headlight cable 9ft (001388lx9) was returned for evaluation.Device history record (dhr): dhr shows no abnormalities related to the reported issue.   evaluation of the returned ul pro fused headlight cable found that the headlight cable was in used condition with damage to the internal fibers due to rough handling/environmental damage.The issue of smoking could not be duplicated.This complaint may be the result of debris on the lens or use with an incompatible light source.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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: 14760546
• Report Number: 3006697299-2022-00090
• Device Sequence Number: 6153048
• 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): 07/12/2022

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: WO180394
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/12/2022
• 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