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

Model Number	RF-NE-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the probe was non-functional.The procedure was cancelled.
Event or Problem Description
There were no patient consequences.
Additional Manufacturer Narrative
Additional information: d10, g4, g7, h2, h3, h6, h10.One reusable electrode was returned to the manufacturer for analysis.An error message was noted on the generator when the electrode was connected and no temperature was displayed.Electrical testing revealed high, variable resistance between the thermocouple wires, consistent with the error message displayed.The source of the high resistance was isolated to within the hub and tubing assembly.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the high and variable resistance remains unknown.

• Brand Name: REUSABLE ELECTRODE, 10CM, NITINOL
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): MINTA MEDICAL LIMITED; caddick road; merseyside knowsley L34 9 HP; UK L34 9HP
• MDR Report Key: 9365173
• Report Number: 3004617090-2019-00001
• Device Sequence Number: 2606404
• Product Code: GXI
• UDI-Device Identifier: 05415067025180
• UDI-Public: 05415067025180
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K090608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: RF-NE-10
• Device Catalogue Number: RF-NE-10
• Device Lot Number: M14329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 11/27/2019; 01/14/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/26/2019; 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1