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

Model Number RF-NE-10

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

One 10 cm, nitinol reusable rf thermocouple electrode was received for evaluation.An error message was noted on the generator when the electrode was connected, and no temperature was displayed.Electrical testing revealed high, variable resistance between the thermocouple wires, consistent with the error message displayed.The source of the high resistance was isolated to within the hub and tubing assembly.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the high and variable resistance remains unknown.

Event Description

During device preparation, when the probe was connected to the generator, the generator would beep and the screen would lock up.Troubleshooting was unable to resolve the issue.The patient was already prepared for the procedure when the case was cancelled.There were no adverse consequences to the patient.

• Brand Name: REUSABLE ELECTRODE, 10CM, NITINOL
• Type of Device: 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10481854
• MDR Text Key: 205303367
• Report Number: 3004617090-2020-00004
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 05415067025180
• UDI-Public: 05415067025180
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RF-NE-10
• Device Catalogue Number: RF-NE-10
• Device Lot Number: M15958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2020
• Date Device Manufactured: 01/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1