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

Catalog Number	00MLX
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the mlx 300w xenon lightsource (00mlx) unit had a burning smell.There was no patient involvement; thus, no injury, death, or surgical delay was reported.
Additional Manufacturer Narrative
The mlx 300w xenon lightsource (00mlx) was returned for evaluation.Failure analysis: the xenon lightsource was received in used condition.Evaluation could not duplicate the burning smell problem.During the evaluation, the mlx would not power on.The power supply unit (psu) had severe physical damage.Waiting for approval for the repair.Root cause analysis: the reported complaint was confirmed.The unit would not power on due to severe damage to the power supply, likely from rough handling or environmental factors.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• Common Device Name: N/A
• 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: 23297005
• Report Number: 3006697299-2025-00117
• Device Sequence Number: 4863608
• 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
• Report Date (Section B): 10/14/2025

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
• Date Returned to Manufacturer: 09/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 06/25/2019
• 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