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

Catalog Number 00MLXEU

Device Problem 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/euro power cord (00mlxeu) was not switching on, and when the unit switched on, the fuse blown off.The facility has not reported if there was patient involvement, injury or surgical delay related to this event.

Manufacturer Narrative

Xenon lightsource w/euro power cord (00mlxeu) was returned for evaluation: device history record (dhr) - the dhr was not reviewed as the reported complaint of the unit blowing fuses is being addressed by a quality plan and is not related to a manufacturing non-conformance.Failure analysis & root cause - the reported failure is being addressed by internal quality plan to address the root cause and corrective actions for issues relating to customer reported issue.As an interim solution, integra can replace components of the mlx lighting units to restore functionality.At present, we consider this complaint to be closed.Trends will be monitored for this and similar issues.

• Brand Name: MLX 300 XENON LIGHTSOURCE W/EURO POWER CORD
• 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: 14106621
• MDR Text Key: 298717053
• Report Number: 3006697299-2022-00051
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00MLXEU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Date Manufacturer Received: 03/24/2022
• 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