MAUDE Adverse Event Report: MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 10CM, NITINOL; PROBE, RADIOFREQUENCY LESION

Model Number RF-NE-10

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Concomitant device: reusable electrode, 10cm, nitinol.The device functioned as intended during a simulated lesion test.No visual or functional anomalies were noted.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the reported smoking remains unknown.

Event Description

Related manufacturing ref: 3004617090-2020-00002.During device testing, the probes started smoking when testing on the grounding pad.There was no patient involved.

• Brand Name: REUSABLE ELECTRODE, 10CM, NITINOL
• 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: 9744198
• MDR Text Key: 180519778
• Report Number: 3004617090-2020-00003
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 05415067025180
• UDI-Public: 05415067025180
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: RF-NE-10
• Device Catalogue Number: RF-NE-10
• Device Lot Number: M14597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• 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