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

Catalog Number 00MLX

Device Problem Smoking (1585)

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

Event Date 02/16/2024

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.Full name of reporting facility: hospital.

Event Description

A facility reported that the mlx 300w xenon lightsource (00mlx) started smoking while in use.The biomedical engineer was reportedly able to troubleshoot the issue to a broken amber colored piece of plastic that holds a lens.The lens was lying in the bottom.There was a 15-minute delay to grab another light source.No patient injury, or death has been reported.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• 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: 18918833
• MDR Text Key: 337856583
• Report Number: 3006697299-2024-00027
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00MLX
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• 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