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

Catalog Number	00MLX
Medical Device Problem Codes	Smoking (1585); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
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 when the mlx 300w xenon lightsource (00mlx) was turned on, it started smoking and now does not power on.There was no patient involvement; thus, no injuries, death, or delays were reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.00mlx mlx 300w xenon lightsource was returned for evaluation.Failure analysis: the xenon lightsource (00mlx) was in used condition.The evaluation identified that the unit had blown fuses and a non-functional power supply unit (psu).To fix this unit, the fuses and psu were replaced.The event of a blown fuse is a failsafe to ensure the safety of the device and the user in the event of an electrical overload.The fuse can be replaced following the information for use (ifu).International electrotechnical commission (iec 60601) certified fuses prevent the risk of harm.This described failure has been addressed through corrective action reports (cars).Root cause analysis: the probable root cause for this is that the specified kilovolt trigger from the power.Supply unit was less than the minimum required by the lamp.The issue with the unit "smoking" could be due to a blown fuse.
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: 24035805
• Report Number: 3006697299-2025-00143
• Device Sequence Number: 10498827
• 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): 03/12/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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