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

Device Problem Output Problem (3005)

Patient Problem No Information (3190)

Event Date 12/15/2020

Event Type  Injury  

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: 2184149-2020-00235.During a monopolar lesion procedure, after placing the needle and connecting the probe, the generator displayed an error message "unsafe probe and connection check probe and connectors" and the procedure was cancelled.A grounding pad test was performed and the issue was reproduced.It was not able to be determined if the generator or probe caused the issue as no other probes were available at the time of the event.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11159369
• MDR Text Key: 226558270
• Report Number: 3004617090-2021-00001
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/15/2020
• 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: NT1100 GENERATOR
• Patient Outcome(s): Other