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

Model Number 90620US

Device Problem Overheating of Device (1437)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the light of the duo headlight and carrying case (b)(4) was "flickering on and off".In addition, the led lamp seemed to be "getting excessively hot".It was reported that the event occurred during a case.The device was not in contact with a patient.No injury, death or surgical delay occurred.

Manufacturer Narrative

Updated fields: d4 (udi#), the duo headlight and carrying case (90600) was returned for evaluation: failure analysis: the duo headlight was received in used condition.Evaluation identified that the unit's power cord was losing connection, leading to the fan malfunctioning and the light flickering.The power cord was replaced to address this issue.Following replacement of the power cord, the unit failed the light quality test with artifacts in the light image.The duo headlight will be sent out to the manufacturer for luminaire repair.Root cause analysis: the reported complaint was confirmed.The issue of the power cord losing connection is most likely due to routine use and wear.The malfunctioning fan most likely resulted in the unit overheating.Evaluation also identified that the luminaire required repair.No manufacturing, workmanship, or material deficiency has been identified.

Event Description

N/a.

• Brand Name: DUO HEADLIGHT AND CARRYING CASE
• 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: 16263958
• MDR Text Key: 308415487
• Report Number: 3006697299-2023-00005
• 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,Followup
• Report Date: 03/20/2023

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: Health Professional
• Device Model Number: 90620US
• Device Catalogue Number: 90600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 03/20/2023
• 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