ET20S™ NT7209975Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067022325), received between May 6, 2019 and Oct 4, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2022Unexpected Shutdown; Unexpected Shutdown

  DURING THE PROCEDURE, THE GENERATOR WOULD SHUT OFF AND RESTART ON ITS OWN. IT WOULD RESTART WITH EACH LEVEL, HOWEVER AFTER THE 4TH LEVEL, THE GENERATOR DID NOT WORK. THE LAST LEVEL OF THE PROCEDURE COULD NOT BE COMPLETED AS A RESULT, BUT THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536127 ↗
• InjuryJan 28, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING A RADIOFREQUENCY ABLATION PROCEDURE, THE GENERATOR DISPLAYED "NO THERMOCOUPLE DETECTED" AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11244953 ↗
• InjuryNov 12, 2019Failure to Deliver Energy; Failure to Deliver Energy

  DURING A PROCEDURE, WHILE PERFORMING SENSORY MOTOR TESTING A RED LIGHT DISPLAYED AND THE GENERATOR NO LONGER FUNCTIONED AS INTENDED. THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9309299 ↗
• InjuryMay 31, 2019High impedance; High impedance

  DURING THE PROCEDURE, A WARNING 2: HIGH LOAD IMPEDANCE ERROR MESSAGE DISPLAYED AND THE PROCEDURE WAS CANCELLED. MULTIPLE PROBES, ADAPTERS AND GROUNDING PADS WERE ATTEMPTED WITH NO RESOLUTION. ALL CONNECTIONS WERE CHECKED WITH NO AND NO ISSUES WERE FOUND AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658255 ↗
• InjuryMay 6, 2019Output Problem; Output Problem

  THE GENERATOR DISPLAYED AN ERROR INDICATING AN ISSUE WITH THE PROBE AND THE CASE WAS ABANDONED. DURING A STANDARD RADIOFREQUENCY PROCEDURE FOR LUMBAR TARGET, A "FAULT 06¿ ERROR MESSAGE OCCURRED MULTIPLE TIMES DESPITE CYCLING THE MACHINE AND CHANGING OUT PROBES. THE GENERATOR WAS POWERED OFF AND ON WHICH DID NOT RESOLVE THE ISSUE AND THE CASE WAS ABANDONED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE ABANDONED PROCEDURE. THE CASE WAS RESCHEDULED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MACHINE WITH NO CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8582632 ↗