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

Catalog Number 00MLX

Device Problems Overheating of Device (1437); Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

The mlx 300w xenon lightsource (00mlx) was returned for evaluation: failure analysis - the mlx 300w xenon lightsource was received in used condition.The depot technician was able to duplicate the unit not powering on.During the evaluation, it was found that the unit was extremely dusty inside, the power supply unit (psu) needed to be upgraded and the left side panel was cracked.The psu, lamp and left side panel were replaced.Evaluation and function test were performed and unit passed all tests.Root cause analysis - the reported complaint was confirmed.The issue of this xenon lightsource smoking was most likely due to damage to the unit combined with improper cleaning, leading to the dust smoking and the unit overheating.No manufacturing, workmanship, or material deficiency has been identified.

Event Description

It was reported that parts inside the mlx 300w xenon lightsource (00mlx) smokes and nothing is working when the unit's power is turned on.It is unknown under what circumstance this event occurred; however, no injury.Death or surgical delay has been reported.

Manufacturer Narrative

Updated fields: g3, g6, h2, h10, h11.Corrected field: h6 (medical device problem code).

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: 17669801
• MDR Text Key: 322493289
• Report Number: 3006697299-2023-00092
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

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: Other
• Device Catalogue Number: 00MLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2023
• 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