MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT 2 BAY SYSTEM - US; LIGHTING

Catalog Number	90620US
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The duo headlight 2 bay system - us (90620us) was returned for evaluation: failure analysis: the returned 90620us duo headlight was in used condition.The evaluation identified that the headlight power cord connector was short-circuiting, causing the fan to stop, resulting in the unit overheating.The issue of a ¿short"refers to a poor connection of the power pins that can potentially result in a failing connection to the battery port.No risk of harm would be incurred by this type of short, and the low voltage would not cause a hazard." root cause analysis: the reported complaint was confirmed.The reported issue with this 90620us duo headlight was most likely due to routine use and wear.No manufacturing, workmanship, or material deficiency has been identified.
Event or Problem Description
A facility reported that the product duo headlight 2 bay system - us (90620us) light was pulsing when in operation, signifying that it was probably overheating, as the fan on top was not spinning anymore.There was no patient involvement, and no injuries or surgical delays were reported.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - US
• 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: 24661781
• Report Number: 3006697299-2026-00026
• Device Sequence Number: 9344480
• Product Code: FSR
• UDI-Device Identifier: 10381780490746
• UDI-Public: 10381780490746
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: 90620US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/23/2026
• 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