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

Model Number	RF-SE-10
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number: 3004617090-2018-00010, 3002953813-2018-00091.During a bi-polar ablation procedure, the probes connected to ports 1 and 2 did not reach temperature and one of the probes melted.The probes were replaced, the generator was power cycled, and the outlet changed, but the temperature issue remained.The procedure was cancelled, but there were no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: the reported temperature issue could not be confirmed.The device functioned as intended during a simulated lesion test.No functional anomalies were noted.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the temperature issue remains unknown.

• 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
• MDR Report Key: 8148763
• Report Number: 3004617090-2018-00011
• Device Sequence Number: 1961818
• Product Code: GXI
• UDI-Device Identifier: 05415067025227
• UDI-Public: 05415067025227
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 12/20/2018

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-SE-10
• Device Lot Number: M13607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEUROTHERM RF ELECTRODE; NEUROTHERM RF GENERATOR
• Outcome Attributed to Adverse Event: Other