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

Catalog Number 00MLX

Device Problems Break (1069); 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.Evaluation identified that the unit had physical damage to the turret, bezel, and the mirror.The unit failed lumens test of under 500 lumens and unit failed the attenuation test; the bezel, turret, mirror, lamp and the attenuator switch have been replaced to correct these issues.In addition to the repair summary, the unit failed the attenuator memory test; the control board has been replaced to correct this issue.Root cause: the reported complaint was confirmed.It was determined that the damage was most likely due to rough handling/environmental damage.No manufacturing, workmanship, or material deficiency has been identified.

Event Description

It was reported that the mlx 300w xenon lightsource (00mlx) has a broken turret causing smoking when plugged in.It is unknown if there was patient involvement; however, no patient injury, death or surgical delay has been reported.

Manufacturer Narrative

Corrected field: h6 (medical device problem code 1585 replaces 1437 (reported in error) on initial medwatch report).

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: 17670468
• MDR Text Key: 322501815
• Report Number: 3006697299-2023-00093
• 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: 09/15/2023

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: 08/03/2023
• 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