MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT 2 BAY SYSTEM - US; PFM05

Catalog Number	90620US
Medical Device Problem Codes	Overheating of Device (1437); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the duo headlight 2 bay system - us (90620us) fan was not working and overheating, making the light flicker.There was no patient injury or surgical delay reported.
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.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The duo headlight 2 bay system (90620us) was returned for evaluation.Failure analysis: the returned 90620us duo headlight was in used condition.The 90620us duo headlight 2 bay system evaluation could not replicate customer customer-stated issue; the fan appears to function properly; however, the evaluation identified that the power cord was broken, which turns the light off.The issues of the unit overheating or the fan malfunctioning could not be duplicated.The issue of the unit flickering was most likely due to the damaged power cable.The reported complaint is confirmed.No manufacturing, workmanship, or material deficiency has been identified.Root cause analysis - the reported complaint was confirmed.The evaluation identified that the power cord is broken and turns the light off.This is most likely due to rough handling/environmental damage.The issues of the unit overheating or the fan malfunctioning could not be duplicated.The issue of the unit flickering is most likely due to the damaged power cable.
Event or Problem Description
N/a.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - US
• Common Device Name: PFM05
• 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: 23393807
• Report Number: 3006697299-2025-00121
• Device Sequence Number: 13306824
• 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,Followup
• Report Date (Section B): 11/13/2025

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: Health Professional
• Device Catalogue Number: 90620US
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/13/2025
• 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