MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT AND CARRYING CASE; PFM05

Model Number	90620US
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
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 and carrying case (b)(4) was "flickering on and off".In addition, the led lamp seemed to be "getting excessively hot".It was reported that the event occurred during a case.The device was not in contact with a patient.No injury, death or surgical delay occurred.
Additional Manufacturer Narrative
Updated fields: d4 (udi#), the duo headlight and carrying case (90600) was returned for evaluation: failure analysis: the duo headlight was received in used condition.Evaluation identified that the unit's power cord was losing connection, leading to the fan malfunctioning and the light flickering.The power cord was replaced to address this issue.Following replacement of the power cord, the unit failed the light quality test with artifacts in the light image.The duo headlight will be sent out to the manufacturer for luminaire repair.Root cause analysis: the reported complaint was confirmed.The issue of the power cord losing connection is most likely due to routine use and wear.The malfunctioning fan most likely resulted in the unit overheating.Evaluation also identified that the luminaire required repair.No manufacturing, workmanship, or material deficiency has been identified.
Event or Problem Description
N/a.

• Brand Name: DUO HEADLIGHT AND CARRYING CASE
• 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: 16263958
• Report Number: 3006697299-2023-00005
• Device Sequence Number: 19934111
• 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): 03/20/2023

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: Health Professional
• Device Model Number: 90620US
• Device Catalogue Number: 90600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/20/2023
• 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