MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US; LIGHTING

Model Number 90520US

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

The led headlight (90520us) was returned for evaluation: device history record (dhr): the dhr was been reviewed and shows no abnormalities related to the reported issue.Evaluation identified physical damage throughout the unit due to rough handling/environmental damage, including the rear cover.Damaged rear cover would prevent proper fan function and lead to overheating.The reported complaint was confirmed from the evaluation.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.

Event Description

A facility made a repair request for the led headlight (90520us) with the reason for request stating "headlight overheats." additional information was sought from the facility and we received the following information: "i assume the overheating happened during procedure; however, i only received unit to send as a repair, don't know all the details." no patient injury or surgical delay has been reported.

• Brand Name: LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US
• Type of Device: LIGHTING
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 12140419
• MDR Text Key: 261705499
• Report Number: 2523190-2021-00128
• Device Sequence Number: 1
• Product Code: FSR
• UDI-Device Identifier: 10381780168607
• UDI-Public: 10381780168607
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 07/08/2021

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: 90520US
• Device Catalogue Number: 90520US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• 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