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

Model 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
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 light of the duo headlight 2 bay system (90620us) was getting too hot.It is unknown under which circumstance this event occurred; however.No injury, death or surgical delay was reported.
Additional Manufacturer Narrative
Evaluation of the returned duo headlight 2 bay system (90620us) could not duplicate any issues with this unit overheating.The probable root cause of this duo headlight overheating could be due to the fan inside the unit not functioning properly.However, service and repair department could not find any issues with this unit, including the fan.The reported complaint could not be confirmed.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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: 15817385
• Report Number: 3006697299-2022-00155
• Device Sequence Number: 7027925
• 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,Followup
• Report Date (Section B): 12/22/2022

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 Model Number: 90620US
• 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): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/22/2022
• 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