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

Catalog Number	00MLX
Medical Device Problem Codes	Break (1069); Smoking (1585); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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) bracket inside the hold glass square was broken, was smoking through the front hole, was flickering, and had no light.There was no patient involvement; therefore, no injuries, deaths, or surgical delays were reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h4, h6, h11.The mlx 300w xenon lightsource (00mlx) was not returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.The 00mlx mlx 300w xenon lightsource was not returned for evaluation after three good faith attempts (gfes) were made.Failure analysis cannot be completed due to the lack of information received to perform a complete investigation.However, the probable root cause for the bracket inside the unit that holds the glass square for this 00mlx mlx 300w xenon lightsource being broken and smoking is damage caused by rough handling/environmental damage.The reported complaint could not be confirmed.If additional relevant information becomes available in the future, this complaint will be reopened and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• 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: 23720824
• Report Number: 3006697299-2025-00136
• Device Sequence Number: 8532031
• 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): 02/02/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2017
• 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