Megadyne 1400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10614559101933), received between May 16, 2018 and May 3, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K050579); they may or may not involve this specific model.

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.

• MalfunctionMay 3, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE FOOT SWITCH STUCK AND THE DEVICE CONTINUED TO ACTIVATE. NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760607 ↗
• MalfunctionFeb 22, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UMBILICAL HERNIA PROCEDURE, THE COAG FOOT PEDAL STICKS AND WILL NOT RELEASE AFTER THE PRESSURE IS RELEASED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357769 ↗
• MalfunctionJan 21, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN PRESSING THE CUT FOOT PEDAL, THEN RELEASING THE FOOT OFF THE CUT SIGNAL & SOUND KEPT ON AFTER THE FOOT RELEASED OFF THE PEDAL. THIS DELAYED THE PROCEDURE BY TWO MINUTES WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207357 ↗
• MalfunctionMay 16, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT WHILE USING A MONOPOLAR FOOT PEDAL, ACTIVATION WILL CONTINUE AFTER THE SURGEON STEPS OFF OF THE FOOT PEDAL UNTIL THE ELECTRODE IS REMOVED FROM TISSUE. THE SALES REP CONFIRMED THAT THE FOOT PEDAL IS NOT STICKING AND THAT ACTIVATION WORKS PROPERLY WITH HAND ACTIVATION. PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7518874 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050579. One submission often covers many models, so check the product and lot details in each record.

• Z-2792-2018 · May 15, 2018 · Terminated
  MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715