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

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	08/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the light source of mlx 300w xenon lightsource (00mlx) was emitting too much heat, which caused the cable to burn on the integra headset.There was no patient involvement; thus, no patient injury, death, or surgical delay was 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
Updated fields: d9, g3, g6, h1, h2, h3 h6, h11.00mlx mlx 300w xenon lightsource was returned for evaluation.Failure analysis: the xenon lightsource was received in used condition.Evaluation identified that the unit has been extensively worked on by a third party.This includes glue holding the bezel together, glue holding the ferrite core down, and the ac entry has been destroyed and held in place with zip ties and glue.The unit had to receive a chassis replacement because the old ac could not be removed without breaking the chassis.The unit had a damaged bezel, control board, ac entry, side panel, front plate, j20r, and chassis.To fix this unit, the bezel, chassis, control board, ac entry, side panel, front plate, and j20r clip were replaced.Root cause analysis: the reported complaint was confirmed.Evaluation identified that the unit has been worked on by a third party.This includes glue holding the bezel together, glue holding the ferrite core down, and the ac entry has been damaged and is held in place with zip ties and glue.This is most likely due to rough handling/environmental damage.No manufacturing workmanship or material deficiency has been identified.
Event or Problem Description
N/a.

• 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: 22992670
• Report Number: 3006697299-2025-00106
• Device Sequence Number: 15806038
• 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): 09/30/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2016
• 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