MAUDE Adverse Event Report: MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 15CM, NITINOL; PROBE, RADIOFREQUENCY LESION

Model Number	RF-NE-15
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the probe caused cauterization of tissue resulting in difficult removal and was not heating to temperature.The probe was replaced to complete the procedure.
Additional Manufacturer Narrative
Correction: additional information indicates that the procedure was completed and the probe was able to be removed.This device is no longer considered to be reportable.

• Brand Name: REUSABLE ELECTRODE, 15CM, NITINOL
• Common Device Name: 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16475739
• Report Number: 3004617090-2023-00003
• Device Sequence Number: 7325939
• Product Code: GXD
• UDI-Device Identifier: 05415067025197
• UDI-Public: 05415067025197
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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 Model Number: RF-NE-15
• Device Catalogue Number: RF-NE-15
• Device Lot Number: M18402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown