MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT AND CARRYING CASE; LIGHTING

Catalog Number	90600
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
The duo headlight and carrying case (9600) was returned for evaluation: failure analysis: the xenon lightsource was received in used condition.Evaluation identified that the light gets hot due to a damaged fan wire and power cord.Evaluation also identified that there was a rattle coming from the luminaire, the light field was hazy, the luminaire must be replaced, and the screw holes of the headband are damaged.This is most likely due to rough handling/environmental damage.Root cause analysis: the reported complaint was confirmed.The light gets hot, and this is due to a damaged fan wire and the power cord.No manufacturing, workmanship, or material deficiency has been identified.
Event or Problem Description
A facility reported that the duo headlight and carrying case (90600) lamp began to blink and ¿gets really hot; the fan does not work.¿ no injury, death, or increase in surgical time was reported.

• Brand Name: DUO HEADLIGHT AND CARRYING CASE
• Common Device Name: LIGHTING
• 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: 24257536
• Report Number: 3006697299-2026-00001
• Device Sequence Number: 8326808
• Product Code: FSR
• UDI-Device Identifier: 10381780491064
• UDI-Public: 10381780491064
• Combination Product (Y/N): N
• PMA/510(K) Number: 510K EXEMPT
• 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
• Report Date (Section B): 02/04/2026

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: 90600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/04/2026
• 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