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

Catalog Number 00MLX

Device Problems Overheating of Device (1437); Separation Problem (4043)

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

Event Type  malfunction  

Manufacturer Narrative

The mlx 300w xenon lightsource (00mlx) was returned for evaluation: failure analysis - the mlx 300w xenon lightsource was received in used condition.Evaluation of the xenon lightsource identified that the unit failed the turret rotation, the cable insertion test, the ac ferrite inside the unit was damaged.In addition, the bezel had internal damage.The turret, ac ferrite and the bezel have been replaced to correct these issues.Root cause analysis.The reported complaint was confirmed.It was determined that the issue of the light cord selector being burnt could be due to damage caused by rough handling/environmental damage.No manufacturing, workmanship, or material deficiency has been identified.

Event Description

A facility reported that the light cord selector of the mlx 300w xenon lightsource (00mlx) was burnt.In addition, the light filter had fallen out of its holder.It was noted that there was no damage to the filter or holder.It is unknown under what circumstance this event was discovered; however, no patient injury, death or surgical delay was 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: 18937227
• MDR Text Key: 338451562
• Report Number: 3006697299-2024-00028
• Device Sequence Number: 1
• Product Code: FCW
• UDI-Device Identifier: 10381780168140
• UDI-Public: 10381780168140
• 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: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 00MLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Date Manufacturer Received: 02/22/2024
• 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