MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - AU; LIGHTING

Catalog Number 90520AU

Device Problem Device Emits Odor (1425)

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

Event Type  malfunction  

Manufacturer Narrative

Led headlight (90520au) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported issue.Failure analysis & root cause: the reported complaint is confirmed: the returned 90520au headlight is in used condition with a burnt pcb as well as damage to the rear cover due to rough handling/environmental damage.Damaged cover would prevent proper ventilation, and led to the issue of a burnt pcb no further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

A facility reported that the led headlight (90520au) had a burning smell.The facility has not reported if there was patient involvement, injury or surgical delay related to this event.

• Brand Name: LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - AU
• Type of Device: LIGHTING
• 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: 14031338
• MDR Text Key: 298420660
• Report Number: 3006697299-2022-00048
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2022

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 Catalogue Number: 90520AU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/06/2022
• 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