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

Catalog Number	90620US
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 2 bay system - us (90620us) was returned for evaluation: the duo headlight 2 bay system was received in used condition.The depot technician completed the evaluation of the duo headlight and could not duplicate any issues with the duo headlight overheating or flickering.The unit passed all tests.The customer reported that the fan stops intermittently.It was determined that the issue could be a malfunctioning battery holster issue; however, the customer did not return the unit with the holster for evaluation.The unit will be send back with a new holster to correct the fan stop issue.The reported complaint could not be confirmed.No manufacturing, workmanship, or material deficiency has been identified.
Event or Problem Description
It was reported that the cooling fan of the duo headlight 2 bay system - us (90620us) operated intermittently, causing the light to overheat and flicker.It is unknown under what circumstance this event occurred; however, no patient injury, death or surgical delay was reported.

• 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 ; 6099362319
• MDR Report Key: 17716543
• Report Number: 3006697299-2023-00099
• Device Sequence Number: 6891149
• Product Code: FSR
• UDI-Device Identifier: 10381780490746
• UDI-Public: 10381780490746
• Combination Product (Y/N): N
• PMA/510(K) Number: 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): 09/08/2023

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: 90620US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/08/2023
• 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