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); Defective Component (2292); Intermittent Energy Output (4025)
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 duo headlight 2 bay system - us (90620us) fan was not working and overheating making the light to flicker.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6,h2, h3, h6, h11.The device duo headlight 2 bay system (90620us) was returned for evaluation.Failure analysis: the 90620us duo headlight was received in used condition.The evaluation identified that the headlight power cord connector is short-circuited and the holster is damaged.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.This is most likely due to rough handling/environmental damage.The reported complaint is confirmed.No manufacturing, workmanship, or material deficiency has been identified.Root cause analysis: the reported complaint was confirmed.Evaluation identified that the headlight power cord connector is short-circuited, and the holster is damaged.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.

• 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: 23393386
• Report Number: 3006697299-2025-00122
• Device Sequence Number: 21293065
• 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): 11/11/2025

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: 09/30/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/11/2025
• 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