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	10/10/2025
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 the mlx 300w xenon lightsource (00mlx) was not functioning properly and emitted a burning smell during use.There was no patient involvement; thus, no injuries, death, or delays were reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g, h2, h3, h6, h11.00mlx mlx 300w xenon lightsource was returned for evaluation.The device history record (dhr) could not be completed due to no valid lot number or serial number being provided.Failure analysis: the xenon lightsource was received in used condition.Evaluation identified that the bezel, right side panel, turret, and top trim were damaged.Evaluation also identified that there was a smell coming from the power supply unit.The lamp, bezel, lamp wire, turret, lens, power supply unit (psu), top trim, and right-side panel were replaced.The issue of this 00mlx unit producing a smell is most likely due to rough handling/environmental damage.An evaluation and function test was performed, and the mlx passed all tests.Root cause analysis: the reported complaint was confirmed.Evaluation identified that the bezel, right side panel, turret, and top trim were damaged.Evaluation also identified that there was a smell coming from the power supply unit.The issue of this 00mlx unit producing a smell is most likely due to rough handling/environmental damage.
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: 23468983
• Report Number: 3006697299-2025-00125
• Device Sequence Number: 8919268
• 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): 01/02/2026

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: 10/13/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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