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

Model Number	RF-NE-10
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant device: reusable electrode, 10cm, nitinol.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .
Event or Problem Description
Related manufacturing ref: 3004617090-2020-00003.During device testing, the probes started smoking when testing on the grounding pad.There was no patient involved.
Additional Manufacturer Narrative
The device was returned due to a "smoking probe" while testing on the grounding pad.The electrode displayed a temperature increase when exposed to heat, however the device did not function as intended during a simulated lesion test.Further investigation revealed, no broken wires were identified and the probe passed dimensional and functional testing.The device was dissected and revealed no anomalies.The device was manufactured according to specifications as supported by the receiving inspection results and all electrodes produced for abbott are confirmed to be conforming to product specifications via in-process controls prior to shipment per 100% continuity and resistance testing at minta.The cause of the temperature issue 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: 9744181
• Report Number: 3004617090-2020-00002
• Device Sequence Number: 19453627
• Product Code: GXI
• UDI-Device Identifier: 05415067025180
• UDI-Public: 05415067025180
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: Other
• Device Model Number: RF-NE-10
• Device Catalogue Number: RF-NE-10
• Device Lot Number: M15455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1