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

Model Number 90620US

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The duo headlight 2 bay system - us (90620us) was returned for evaluation: failure analysis: the returned duo headlight was received in used condition.Evaluation could not identify any issues with the headlight overheating or flickering; however, evaluation did identify that the fan was loud while the unit was tested.The fan has been replaced and the unit was tested and passed all the testing.Root cause analysis: the reported complaint could not be confirmed.The issue of the unit overheating and flickering could be due to a malfunctioning fan.No manufacturing, workmanship, or material deficiency has been identified.

Event Description

It was reported that the cooling fan of the duo headlight 2 bay system - us (90620us) operated intermittently, causing the light to overheat & 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
• Type of Device: 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: 17247220
• MDR Text Key: 318551255
• Report Number: 3006697299-2023-00070
• Device Sequence Number: 1
• Product Code: FSR
• UDI-Device Identifier: 10381780490746
• UDI-Public: 10381780490746
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2023

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
• Device Operator: Other
• Device Model Number: 90620US
• Device Catalogue Number: 90620US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1