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	01/14/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A facility reported that the mlx 300w xenon lightsource (00mlx) had a burning smell.They reported that they "opened the device and found that the holder for the ir glass that is located in front of the light bulb." it is unknown whether there was patient involvement, injury, death, or surgical delay.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The mlx 300w xenon lightsource (00mlx) was not returned for evaluation.Therefore, an evaluation of the device could not be performed.The device history record (dhr) could not be completed because no lot number or serial number was provided.The definite root cause cannot be identified as the device was not returned.Based on the reported complaint, the probable root cause of this 00mlx mlx 300w xenon lightsource producing a burning smell and overheating is a broken mirror apparatus.The reported complaint could not be confirmed.When relevant information becomes available in the future, this complaint will be reopened, and the appropriate evaluation will be conducted.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• 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: 24482577
• Report Number: 3006697299-2026-00013
• Device Sequence Number: 13433314
• 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,Followup
• Report Date (Section B): 04/28/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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