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

Catalog Number	AX2100BIF
Medical Device Problem Codes	Overheating of Device (1437); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ultralite pro headlight w/premium cable (ax2100bif) was returned for evaluation: failure analysis: the returned of ax2100bif ultralite pro headlight was in used condition.The evaluation of ultralite pro headlight identified that the light was dim.The optic cable was replaced to fix the unit.Root cause analysis: the reported complaint was confirmed.It was determined that the failure was most likely due to routine use and wear.No manufacturing, workmanship, or material deficiency has been identified.
Event or Problem Description
It was reported that the light cord of the ultralite pro headlight w/premium cable (ax2100bif) was "working intermittently, now the headlamp won't work at all." the facility reported that the cord got "hot to touch." it is unknown under what circumstance this event occurred.The device was not in contact with a patient; thus, no patient injury, death or surgical delay was reported.

• 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: 21943770
• Report Number: 3006697299-2025-00049
• Device Sequence Number: 8553806
• 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
• Report Date (Section B): 05/01/2025

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 Catalogue Number: AX2100BIF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/01/2025
• 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