MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. LED HEADLIGHT ONLY; LIGHTING

Model Number 90500

Device Problems Overheating of Device (1437); Unexpected Shutdown (4019)

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

Event Type  malfunction  

Manufacturer Narrative

The led headlight only (90500) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the led headlight found that the luminaire gets really hot; additionally, the unit had a broken module and rear cover.All parts are to be replaced as per estimate to bring unit back to manufacturer's specifications.Root cause analysis: the returned led headlight was in used condition with damage to the module and rear cover due to rough handling/environmental damage.This most likely lead to the fan working sub-optimally and caused the device to overheat.The reported complaint was confirmed.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 only (90500) was overheating and switching itself off.There was no patient involvement and no delay in surgery was reported.

• Brand Name: LED HEADLIGHT ONLY
• 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: 15084284
• MDR Text Key: 304025067
• Report Number: 3006697299-2022-00104
• Device Sequence Number: 1
• Product Code: FSR
• UDI-Device Identifier: 10381780168485
• UDI-Public: 10381780168485
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2022

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 Model Number: 90500
• Device Catalogue Number: 90500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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