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 08/07/2023

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 light box of the mlx 300w xenon lightsource (00mlx) started smoking while plugged in during a procedure (microdirect laryngoscopy, esophogoscopy, biopsy of glottic lesion).It was immediately turned off/unplugged and moved over by the door to operating room 16.The smoking stopped abruptly once the light box was turned off.Healthcare technology management (htm) was called right after the light source was turned off, and it was communicated to put the light box in the htm room once the case was done.A new light box was obtained immediately, which worked appropriately.It was reported that there was no patient harm or delay in care to the patient.

Manufacturer Narrative

Updated fields: d4 (udi#), d9, g3, g6, h2, h3, h6, h10 the mlx 300w xenon lightsource (00mlx) was returned for evaluation: failure analysis - the xenon lightsource was received in used condition.Upon evaluation, the depot technician was unable to duplicate the problem due to not being able to power the unit up.However, it was identified that the xenon lightsource had physical damage to it.The ac entry module was crushed and pushed back into the unit and there was damage to the chassis.There was a lot of dust build-up in the unit.The following parts will be replaced to correct these issues: power supply unit, lamp, ac entry module, chassis, fuses, control board, fans and bezel.Root cause analysis - the reported complaint was confirmed.It was determined that the unit smoking could be due to improper cleaning of the unit as well as damage to the mirror caused by rough handling/environmental damage.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: 18172540
• MDR Text Key: 328631953
• Report Number: 3006697299-2023-00120
• Device Sequence Number: 1
• Product Code: FCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00MLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• 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