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

Model Number	90600
Medical Device Problem Code	Overheating of Device (1437)
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 and carrying case (90600) was flickering intra-operatively.No patient injury, death or surgical delay was reported.Upon further assessment by an integra depot technician, it was noted that the duo headlight/led was overheating.
Additional Manufacturer Narrative
The suspected duo headlight and carrying case (90600) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.The returned duo headlight was received in used condition.Assessment by the depot technician found that the problem of the duo headlight flickering, indicated by the customer could not be confirmed.However, the fan was not working, and when the led overheats, the light intensity decreases/dims.This could be the "flickering" that the customer describes.No manufacturing, workmanship, or material deficiency has been identified.The fan was replaced to correct the issue of dimming.As a preventative measure, the power cable running from the battery to the headlight was replaced, in addition to the connector board and the gear housing.This device has been tested to verify that it meets manufacturer's specifications.

• Brand Name: DUO HEADLIGHT AND CARRYING CASE
• Common Device Name: PFM05
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15476155
• Report Number: 3006697299-2022-00129
• Device Sequence Number: 20334790
• Product Code: FCW
• UDI-Device Identifier: 10381780491064
• UDI-Public: 10381780491064
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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: 90600
• Device Catalogue Number: 90600
• Device Lot Number: L003700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/24/2022
• 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