MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM PORTABLE CONNECTOR MODULE; PORTABLE CONNECTION MODULE

Model Number 21030-045

Device Problems Failure to Disconnect (2541); Temperature Problem (3022)

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

Event Date 10/06/2021

Event Type  malfunction  

Event Description

During an ablation procedure, it was reported that the temperature zone around the probe began to decrease.Upon inspection of the probe to pcm connection, the mating adapter felt warm and the laser fiber could not be disconnected.The laser probe was removed from the patient and a new laser was inserted and used to continue the ablation.There were no patient complications reported in relation to this event.

• Brand Name: NEUROBLATE® SYSTEM PORTABLE CONNECTOR MODULE
• Type of Device: PORTABLE CONNECTION MODULE
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer (Section G): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: jordon honeck ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 12722234
• MDR Text Key: 280947561
• Report Number: 3009970070-2021-00029
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00816589021080
• UDI-Public: 00816589021080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21030-045
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1