MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 10CM, NITINOL CE; PROBE, RADIOFREQUENCY LESION
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Model Number RF-NE-10-CE |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/28/2018 |
Event Type
Injury
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Event Description
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Related manufacturing ref: 3004617090-2018-00013, 3004617090-2018-00014.During the procedure, three electrodes displayed a no thermocouple error and the procedure was cancelled.There were no adverse consequences to the patent due to the cancellation.
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Manufacturer Narrative
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Additional information: the reported error message was confirmed.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 and subsequent procedure cancellation remains unknown.
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