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

Catalog Number 001388LX9

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

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 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.

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 Description

N/a.

• Brand Name: UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM
• Type of Device: 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
• MDR Text Key: 337843019
• Report Number: 3006697299-2024-00025
• Device Sequence Number: 1
• Product Code: FST
• UDI-Device Identifier: 10381780168034
• UDI-Public: 10381780168034
• Combination Product (y/n): N
• PMA/PMN Number: K864380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1