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  

Event Description

It was reported that the led housing of the duo headlight 2 bay system - us ((b)(6)) has pulled apart and had become an infection risk.In addition, the rubber grommet for electrical cord is dry rotted, the battery holder was missing a couple of slim nuts so the power connector on the battery pack cuts power and overheats.It is unknown under what circumstance this event was discovered.No patient injury or surgical delay has been reported.

Manufacturer Narrative

The duo headlight 2 bay system - us ((b)(6)) was returned for evaluation: failure analysis: the duo headlight was received in used condition.Evaluation of the duo headlight found that the headlight luminaire was cracked.Thus, the unit will be sent out to the manufacturer for the luminaire repair.Root cause analysis: the reported complaint is confirmed.Evaluation identified that the headlight luminaire was cracked and required repair.This is most likely due to rough handling/environmental damage.No manufacturing, workmanship, or material deficiency has been identified.

• 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: 18715832
• MDR Text Key: 336533035
• Report Number: 3006697299-2024-00018
• Device Sequence Number: 1
• Product Code: FSR
• 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: 02/15/2024

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: 01/11/2024
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/15/2024
• 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