MAUDE Adverse Event Report: MINTA MEDICAL LIMITED NEUROTHERM ELECTRODE; PROBE, RADIOFREQUENCY LESION

Device Problem Output Problem (3005)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer ref: 3004617090-2021-00003, 3004617090-2021-00004, 3004617090-2021-00005.During the procedure, the generator passed sensory and motor testing, but was not able to lesion and the procedure had to be cancelled.The error message "check connector and probe" message appeared despite all probes being green.The generator was restarted multiple times with no resolution.There were no adverse consequences to the patient.A grounding pad test was conducted two different times with the generator and the issue could not be replicated.As the grounding pad test was passed, the issue was thought to have been with the probes used for the procedure.

• Brand Name: NEUROTHERM ELECTRODE
• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): MINTA MEDICAL LIMITED; caddick road; merseyside knowsley L34 9 HP; UK L34 9HP
• Manufacturer (Section G): MINTA MEDICAL LIMITED; caddick road; merseyside knowsley L34 9 HP; UK L34 9HP
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12312713
• MDR Text Key: 266205403
• Report Number: 3004617090-2021-00006
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NEUROTHERM ELECTRODE.; NEUROTHERM ELECTRODE.; NEUROTHERM ELECTRODE.