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

Model Number	RF-SE-10
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 3004617090-2023-00005.It was reported that during a procedure the probes did not properly heat to desired temperature.As such, the procedure was not completed.Reportedly, the doctor had attempted to insert the probes.
Additional Manufacturer Narrative
Date of event is estimated.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.
Additional Manufacturer Narrative
It was reported to abbott, two rfa needles were not working properly.The rep reported the probes did not properly heat to the desired temperature during the procedure; therefore, the procedure could not be completed.The physician attempted to insert the probes.On (b)(6) 2023, the rep was informed the record would be closed and reopened as needed.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

• Brand Name: REUSABLE ELECTRODE, 10CM, SST
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17183122
• Report Number: 3004617090-2023-00006
• Device Sequence Number: 6392041
• Product Code: GXD
• UDI-Device Identifier: 05415067025227
• UDI-Public: 05415067025227
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/26/2023

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-SE-10
• Device Catalogue Number: RF-SE-10
• Device Lot Number: M18403
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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