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

Catalog Number 00MLX

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  malfunction  

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 Description

A facility reported that the mlx 300w xenon lightsource (00mlx) started smoking when turned on.There was no patient involvement; thus, no patient injury, death or surgical delay occurred.

Manufacturer Narrative

Updated fields: d4 (udi #), g3, g6, h2, h3, h6, h10 the suspected mlx 300w xenon lightsource (00mlx) was returned for evaluation: failure analysis: the xenon lightsource was received in used condition.During evaluation, the depot technician did not duplicate the "smoking" reported by the customer.However, evaluation of the lightsource identified that the bezel cracked inside around the lens area and the power supply unit (psu) had too many clicks when igniting the lamp.The psu and the bezel assembly were replaced.Evaluation and function tests were performed and the unit passed all tests.Root cause analysis: the reported complaint was confirmed.It was determined that the issue with this 00mlx unit smoking when turned on could be due to damage to the mirror caused by rough handling/environmental damage or improper cleaning of the cable ports.No manufacturing, workmanship, or material deficiency has been identified.

Event Description

N/a.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• Type of Device: 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 ; 6099362319
• MDR Report Key: 18650792
• MDR Text Key: 334738685
• Report Number: 3006697299-2024-00012
• Device Sequence Number: 1
• Product Code: FCW
• UDI-Device Identifier: 10381780168140
• UDI-Public: 10381780168140
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 00MLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1