MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE; IMIG

Catalog Number	AX2100BIF
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
A facility reported that the operator smelled burnt fumes while using the ultralite pro headlight w/premium cable (ax2100bif).No visual smoke was detected.The unit was turned off and placed out of service.No patient injury or surgical delay was reported.
Additional Manufacturer Narrative
The ultralite pro headlight w/premium cable (ax2100bif) was returned for evaluation.Failure analysis: evaluation of the unit by the depot technician assessment noted that the fuse in the fiber cable had failed, producing insufficient light output to the module.In addition, the unit failed the light quality test with artifacts in the light image.The fiber cable and module has been replaced to correct these issues.Root cause analysis: the reported complaint was confirmed.The ultralite pro headlight w/premium cable was received in used condition with a failed fuse in the fiber cable.This is likely due to normal wear and tear.

• Brand Name: ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE
• Common Device Name: IMIG
• 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 08540 ; 6099362319
• MDR Report Key: 20154078
• Report Number: 3006697299-2024-00131
• Device Sequence Number: 8301586
• Product Code: FST
• UDI-Device Identifier: 10381780168850
• UDI-Public: 10381780168850
• 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): 10/24/2024

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: Health Professional
• Device Catalogue Number: AX2100BIF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/24/2024
• 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