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

Catalog Number	00MLX
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the mlx 300w xenon lightsource (00mlx) had a burning plastic when used with a non-integra cable during an ear, nose, and throat procedure.They had a concern that the product was overheating, as they were using a cable at ¿max¿ brightness.There were no injuries, deaths, or surgical delays 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.
Additional Manufacturer Narrative
The mlx 300w xenon lightsource (00mlx) was returned for evaluation: the device history record (dhr) was not available for review.Failure analysis: the xenon lightsource was received in used condition.Evaluation could not duplicate any issues with this 00mlx unit malfunctioning.Evaluation also identified that the optic cable was not an integra product.The issue with this 00mlx light source overheating could be due to the non-integra optic cable being incompatible with the lightsource.Root cause analysis: the reported complaint was not confirmed.The issue of this 00mlx unit overheating and burning plastic smell could be due to the non-integra optic cable being incompatible with the light source.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h11.Corrected field: g3 'us regulatory awareness date' was inadvertently entered wrong in the initial mdr.It should be 01/26/2026.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h11.Corrected field: g3 'us regulatory awareness date' was inadvertently entered wrong in the initial mdr.It should be 01/26/2025.
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: 24410540
• Report Number: 3006697299-2026-00008
• Device Sequence Number: 10569972
• 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,Followup,Followup
• Report Date (Section B): 04/29/2026

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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 04/29/2026; 04/29/2026
• Initial Report FDA Received Date: 02/22/2026
• Supplement Report FDA Received Date: 04/06/2026; 04/29/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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