Megadyne 0014MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10614559100172), received between Dec 16, 2019 and Feb 11, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081791, K862221); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLASTIC SURGEON INFORMED THAT THE ELECTRODE SHE USED ON AN IMMEDIATE RECONSTRUCTION AFTER MASTECTOMY CAUSED A BURN MEDIAL TO THE INCISION. THE INSULATION ON THE ELECTRODE WAS COMPROMISED. THE SURGEON EXTENDED THE INCISION 5CM TO REMOVE THE AFFECTED SKIN FROM THE INCISION. ANOTHER ELECTRODE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS A 10MINS OF SURGICAL DELAY WAS REPORTED.

  Patient problems: Superficial (First Degree) Burn; Unspecified Tissue Injury

  MAUDE report 24315612 ↗
• MalfunctionJan 24, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A RADICAL CYSTECTOMY PROCEDURE THAT THE BOVIE TIP CAUGHT ON FIRE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228567 ↗
• InjurySep 29, 2020Self-Activation or Keying; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Self-Activation or Keying; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TUMMY TUCK PROCEDURE THAT THE UNIT WAS RETURNED TO THE CUSTOMER ON (B)(6). THE FIRST DAY USED AFTER THE RETURN THE UNIT WORKED FINE. THE SECOND DAY OF USE THE UNIT IS GIVING AN ERROR 215 2 WHILE USING THEIR NEW MINI VAC AND ULTRA VAC PEN. THE UNIT WAS RESET MULTIPLE TIMES AND IT CONTINUES TO ERROR. STAFF SWITCHED TO THEIR COMPETITOR BOVIE PEN THE UNIT STOPPED ERRORING HOWEVER WHEN THEY STOPPED PRESSING THE CUT/COAG BUTTONS THE GENERATOR CONTINUES TO SOUND AS IF IT IS DELIVERING ENERGY, BUT IT IS NOT. THE SURGEON WAS USING A POWER SETTING 45 BUT HAS HAD TO INCREASE POWER TO 70 TO GET HIS ANTICIPATED RESULT. THE CUT SCREEN SAYS ERROR, COAG SCREEN SAYS 215, AND BIPOLAR SAYS 2. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT AT THE TIME OF THE CALL.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 10599243 ↗
• MalfunctionApr 1, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A BLUE PROTECTOR/INSULATION PIECE ON THE MEGADYNE BOVIE TIP DISLODGED FROM THE BOVIE DURING ROUTINE CLEANING OF THE TIP. THE PIECE WAS CAUGHT BY OR STAFF BEFORE IT FELL INTO AND WAS LOST IN THE CAVITY OF THE PATIENT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911217 ↗
• MalfunctionMar 3, 2020Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A FOREIGN MATTER WAS FOUND INSIDE 0014M AND STAINS WERE ON 0014AM WHEN THE CUSTOMER CHECKED DEVICES. DEVICES WERE NOT USED FOR THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780479 ↗
• MalfunctionDec 16, 2019Fire; Sparking

  IT WAS REPORTED THAT DURING SURGERY, THE ELECTRODE 0014M TOGETHER WITH MEDTRONICS FORCE TRIVERSE (FT3000) STARTED TO SPARK AND CREATED A SMALL FLAME. NO FLUID OR ANYTHING ELSE CAUGHT FIRE. IT WAS REPORTED THERE WERE NO PATIENT CONSEQUENCES. IT'S UNKNOWN WHETHER THE PROCEDURE WAS DELAYED OR COMPLETED SUCCESSFULLY, OR IF FRAGMENTS WERE GENERATED AND EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. IT'S UNKNOWN WHETHER OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9476434 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081791, K862221. One submission often covers many models, so check the product and lot details in each record.

• Z-0486-2010 · Oct 13, 2009 · Terminated
  E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expir