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Model Number RF-NE-10 |
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 08/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Search Alerts/Recalls
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