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

Model Number 90620US

Device Problem Intermittent Loss of Power (4016)

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

Event Type  malfunction  

Event Description

It was reported that while wearing the duo headlight (90620us) during a case, it would stop working and then start working again.It was suspected that the unit had a short in the wire, as there was periodic interruptions in the light being on.As a result, there was a delay of approximately five (5) minutes, long enough to find a replacement.The patient outcome was not changed; the outcome went as expected.No patient injury or death was reported.

Manufacturer Narrative

The duo headlight (90620us) was returned to the manufacturer for evaluation: failure analysis: evaluation of the duo headlight found that the power cord had a short at the end of the cord that caused the light to flicker off/on whenever the cord was moved.The power cord was replaced to correct this issue.Root cause analysis: evaluation identified damage to the power cord due to rough handling/environmental damage.The reported complaint was confirmed.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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: 12917892
• MDR Text Key: 283089434
• Report Number: 3006697299-2021-00059
• 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: 12/02/2021

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: Health Professional
• Device Model Number: 90620US
• Device Catalogue Number: 90620US
• Device Lot Number: L002214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/02/2021
• 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