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

Catalog Number 00MLX

Device Problems Break (1069); Smoking (1585)

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.The depot technician noted that the xenon lightsource was physically taken apart and shipped in.Evaluation identified that the turret was cracked, the bezel was damaged, lamp over 500 hours, and control board failed to stay at 20% after powering back on (therefore, needing a control board).In addition, the right side and top trim were damaged.Root cause analysis: the reported complaint was confirmed.It was determined that the damages were most likely due to rough handling/environmental damage.No manufacturing, workmanship, or material deficiency has been identified.

Event Description

A facility reported that the mlx 300w xenon lightsource (00mlx) has broken plastic in the front housing, causing smoking when plugged in.It is unknown under what circumstance this event occurred; however, no injury, death or surgical delay 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: 17833803
• MDR Text Key: 324468162
• Report Number: 3006697299-2023-00102
• 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• 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: 07/26/2023
• Date Manufacturer Received: 09/05/2023
• 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