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

Catalog 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: 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 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
• 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: 17716543
• MDR Text Key: 323083593
• Report Number: 3006697299-2023-00099
• 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: 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
• Device Operator: Other
• Device Catalogue Number: 90620US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/08/2023
• 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