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

Catalog Number	00MLX
Medical Device Problem Codes	Break (1069); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mlx 300w xenon lightsource (00mlx) was returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the xenon lightsource was received in used condition as one of two units included in this service and repair submission.This unit did not exhibit any issues with the mirror bracket or with emitting smoke.Upon inspection, the device was found to require a power supply upgrade and had a control board failure as well as damage to the right-side trim panel.The power supply was upgraded, and the control board and right-side trim panel were replaced.The unit subsequently passed all service and repair functional testing.Root cause analysis: the reported complaint cannot be confirmed.Evaluation showed that the unit required a power supply upgrade, the control board required replacement, and the right-side trim panel was damaged.These conditions were most likely due to rough handling or environmental damage.The reported issue of the unit producing smoke could not be replicated or confirmed.
Event or Problem Description
A facility reported that the mlx 300w xenon lightsource (00mlx) was found to be broken and emitting smoke from the front opening.There was no patient involvement; therefore, no injuries, deaths, or surgical delays were reported.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• Common Device Name: 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 08540 ; 6099362319
• MDR Report Key: 23960599
• Report Number: 3006697299-2025-00138
• Device Sequence Number: 9610943
• Product Code: FCW
• UDI-Device Identifier: 10381780168140
• UDI-Public: 10381780168140
• Combination Product (Y/N): N
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00MLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown