MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. MLX 300 XENON LIGHTSOURCE W/AUSTRALIAN POWER COR; N/A

Catalog Number 00MLXAU

Device Problem Power Problem (3010)

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

Event Type  malfunction  

Event Description

A facility reported that the mlx 300 xenon lightsource (00mlxau) stopped working and kept blowing the fuse.It has not been reported if there was patient involvement, injury or surgical delay related to this event.

Manufacturer Narrative

Mlx 300 xenon lightsource (00mlxau) 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 00mlxau light source is in used condition with a failing power supply due to wear.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: MLX 300 XENON LIGHTSOURCE W/AUSTRALIAN POWER COR
• Type of Device: N/A
• 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: 14031918
• MDR Text Key: 295447392
• Report Number: 3006697299-2022-00047
• Device Sequence Number: 1
• Product Code: FCW
• 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

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00MLXAU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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