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 08/03/2023

Event Type  malfunction  

Event Description

The following information has been reported to manufacturer via uf/importer report# 5200980000-2023-8005: "a luxtec headlight was plugged in/being used during the patient's direct laryngoscopy procedure and the light box started smoking.It was immediately turned off/unplugged.The smoking stopped abruptly once the light box was turned off." it was reported that there was no harm to the patient.There was no surgical delay, procedure was moved along and a new light source was brought in for use.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow up report will be submitted.

Manufacturer Narrative

The mlx 300w xenon lightsource (00mlx) was returned for evaluation: failure analysis - the xenon lightsource was received in used condition.During the evaluation, the depot technician found the ac entry module was not seated correctly.It appears the ac entry module was glued into the chassis that was bent inward.The unit requires the ac entry module, chassis, right side panel and possibly a power supply unit (psu) and bezel.The bezel, standby and control membrane, power button, ac ferrite core and wires, lamp wires, fuses, ac entry module, left side panel, turret were all replaced.Evaluation and function tests were performed and the unit passed all tests.Root cause - the reported complaint was confirmed.It was determined that the findings were most likely due to routine use and wear.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: 17671242
• MDR Text Key: 322517439
• Report Number: 3006697299-2023-00097
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• 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?: No
• Date Manufacturer Received: 09/19/2023
• 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
• Patient Age: 26 YR
• Patient Sex: Female