MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MLX 300W XENON LIGHTSOURCE; N/A

Catalog Number 00MLX

Device Problem Power Problem (3010)

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

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the power of the xenon lightsource (00mlx) did not turn on before the procedure.When the operator removed the fuse, the fuse was blown.There was no patient injury and delay in surgery is unknown.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The facility indicated that the 00mlx light source will not be returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA
• MDR Report Key: 12054535
• MDR Text Key: 258056225
• Report Number: 2523190-2021-00131
• 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
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• 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: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1