MAUDE Adverse Event Report: Integra LifeSciences (Ireland) Ltd. MLX 300W XENON LIGHTSOURCE; Lighting

Catalog Number	00MLX
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the mlx 300w xenon lightsource (00mlx) worked as intended when used in the operating room (or).However, when the device was powered on and used by technicians, they noticed a burning smell.The device was taken out of service, and troubleshooting was initiated in the shop.Ultimately, no faults or exact source of the odor could be identified.The device was not in contact with a patient, and no patient injury or surgical delay was reported.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

• 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 ; +1(609)936-2319
• MDR Report Key: 50841658
• Report Number: 3006697299-2026-00075
• Device Sequence Number: 10270716
• Product Code: FCW
• UDI-Device Identifier: 10381780168140
• UDI-Public: 10381780168140
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 01/04/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown