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

Catalog Number	00MLX
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 connection failure between the head light and the device, and it caused burns on the main device from overheating.There was no patient involvement, thus no injuries, death, or surgical delays reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.00mlx mlx 300w xenon lightsource was returned for evaluation.The device history record (dhr) was not available to review.Failure analysis - the xenon lightsource was received in used condition.Evaluation identified and replaced the following: broken lens and mirror holder, chipped heat extended range mirror, front vessel melted along with the mlx label, power switch, turret ring, standby switch, and control switch, cracked attenuator motor wire harness, broken power entry filter, cracked left and lower panel, and aging lamp.Root cause - the reported complaint is confirmed.Evaluation identified that the lens and mirror holder are broken, the mirror was damaged, the wire harness is cracked, the left panel and lower panel are cracked, and some components have signs of overheating.The issue with this 00mlx unit with melted components is most likely due to overheating caused by the damaged mirror holder and mirror, resulting from rough handling/environmental damage.

• 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: 24485939
• Report Number: 3006697299-2026-00012
• Device Sequence Number: 10638390
• Product Code: FCW
• UDI-Device Identifier: 10381780168140
• UDI-Public: 10381780168140
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/29/2026
• 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