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

Catalog Number 00MLX

Device Problem Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the xenon lightsource (00mlx) was not performed as the device was not returned to the manufacturer.The device history record (dhr) was not reviewed as the reported complaint is being addressed by internal quality plan and is not related to a manufacturing non-conformance.The quality plan was opened by integra to address the root cause and corrective actions for the described power issue(s).As an interim solution, integra can replace components of the mlx lighting units to restore functionality should the customer later return the device.At present, we consider this complaint to be closed.Trends will be monitored for this and similar issues.

Event Description

A facility reported that xenon light source (00mlx) has a power issue when plugged in.It blows fuses, and has a burning smell.It is unknown whether there was patient involvement; however, no patient injury or surgical delay has been reported.

• 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: 12668892
• MDR Text Key: 277760112
• Report Number: 2523190-2021-00225
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• 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?: No
• Date Manufacturer Received: 09/27/2021
• 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