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

Catalog Number 00MLXAU

Device Problems Circuit Failure (1089); Power Problem (3010)

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

Event Type  malfunction  

Event Description

A facility reported that the mlx 300 xenon lightsource w/australian power cord (00mlxau) was not turning on and continually blowing main fuses.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.

Manufacturer Narrative

The mlx 300 xenon lightsource w/australian power cord (00mlxau) has been returned for evaluation: dhr review: a review of the dhr was not performed, as the described complaint is being addressed per quality plan and is not related to a manufacturing non-conformance.Failure analysis - this described failure is being addressed by internal quality plan for issues relating to power supply, hard start issues, and early-life failure of the lamp module.As an interim solution, integra can replace components of the mlx lighting units to restore functionality.  root cause - the issue of power supply failure is being investigated under internal quality plan to address root cause and corrective actions.

• Brand Name: MLX 300 XENON LIGHTSOURCE W/AUSTRALIAN POWER COR
• 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: 15342693
• MDR Text Key: 305623822
• Report Number: 3006697299-2022-00117
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00MLXAU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Date Manufacturer Received: 08/10/2022
• 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