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

Model Number	RF-NE-15
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 3004617090-2023-00002 it was reported that the probe were non function due to impedance issue.As such, the procedure was not completed.
Additional Manufacturer Narrative
The reported event of a "probe issue" could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device was manufactured according to specifications as supported by the receiving inspection results.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
The reported event of a "probe issue" could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device was manufactured according to specifications as supported by the receiving inspection results.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 16456961
• Report Number: 3004617090-2023-00001
• Device Sequence Number: 12390786
• Product Code: GXI
• UDI-Device Identifier: 05415067025197
• UDI-Public: 05415067025197
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RF-NE-15
• Device Catalogue Number: RF-NE-15
• Device Lot Number: M18144
• Was Device Available for Evaluation?: No
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/10/2023; 06/22/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/27/2023; 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 73 KG