RF MultiGen 0406900000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154578443), received between Apr 24, 2019 and Feb 14, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unintended Electrical Shock” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2020Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCK DURING TESTING OF THE DEVICE. NO MEDICAL INTERVENTION WAS NECESSARY AND NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock

  MAUDE report 9714991 ↗
• MalfunctionSep 24, 2019Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT WAS POSSIBLY BURNED BY THE DEVICE. NO SURGICAL DELAY OR MEDICAL INTERVENTION WAS REPORTED AND THE CASE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Burn(s)

  MAUDE report 9111375 ↗
• MalfunctionSep 24, 2019Grounding Malfunction; Grounding Malfunction

  IT WAS REPORTED THAT THE PATIENT WAS SHOCKED BY THE DEVICE. SURGICAL DELAY WAS REPORTED BUT NO MEDICAL INTERVENTION WAS REPORTED. IT WAS FURTHER REPORTED THAT THE CASE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Shock

  MAUDE report 9111373 ↗
• MalfunctionApr 24, 2019Unintended Electrical Shock; Unintended Electrical Shock

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE DELIVERED AN UNINTENDED ELECTRICAL SHOCK. 1 EVENT HAD PATIENT INVOLVEMENT; PATIENT EXPERIENCED AN UNINTENDED ELECTRICAL SHOCK.

  Patient problems: Electric Shock

  MAUDE report 8545830 ↗