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 xenon lightsource w/australian power cord (00mlxau) was not switching on and had blown fuses.The fuses blew again after replacement.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.

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: 14496077
• MDR Text Key: 292596235
• Report Number: 3006697299-2022-00070
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• 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: 05/04/2022
• Date Manufacturer Received: 05/03/2022
• 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