Megadyne 0014AMRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10614559100165), received between Apr 2, 2019 and May 6, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CONNECTED TO PREVIOUS RELI, BOVIE TIP SPARKED FLAME WHILE IN USE, WAS REMOVED FROM FIELD, NEW BOVIE TIP OBTAINED AND NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969160 ↗
• InjuryApr 21, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BLUE INSULATION CRACKED ON THE SIDE OF THE BOVIE AND BURNED THE SKIN OF HIS PATIENT. HE WAS ABLE TO CUT THE BURN OUT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 21871749 ↗
• MalfunctionApr 24, 2024Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A BREAST MASS EXCISION THE DR USED THE TIP (0014AM) FOR LUMPECTOMY FOR A WHILE, THEN THE INSULATED PART OF THE TIP WAS TOUCHED WITH THE RETRACTOR ACCIDENTLY AND A BIG SPRINKLE RESULTED AND THE SIDE OF THE TIP WAS BURNT. AFTER THAT, THEY CHANGED TO OTHER PIECES WITH ANOTHER LOT NUMBER AND COMPLETED THE SURGERY. ESU POWER 20 & 25 FOR CUTTING & COAGULATION WERE USED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172551 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock; Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DOCTOR WAS HOLDING THE BOVIE PENCIL IN HER HAND. DOCTOR FELT A SHOCK ON HER ABDOMEN. WE BELIEVE THE ELECTRICAL CURRENT JUMPED TO THE METAL ON HER BADGE. DOCTOR BROKE SCRUB. THERE WAS FOUND TO BE A BURN HOLE IN HER SURGICAL GOWN, AND IN HER SCRUB TOP, AND A BURN SITE ON HER ABDOMEN. AT THE TIME OF THE BOVIE BURN, WE WERE USING THE BOVIE GROUNDING PAD ON THE BED. THE BOVIE UNDERPAD WAS INTACT. AFTER THE BURN OCCURRED, A BOVIE PAD WAS PLACED ON THE RIGHT THIGH OF THE PATIENT, AND WE USED THIS GROUNDING PAD RATHER THAN THE UNDERPAD. FOLLOWED UP WITH DOCTOR AND SHE REPORTED THAT SHE WAS DOING WELL.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17265502 ↗
• MalfunctionJun 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MODIFIED TIP PART DEPARTED TOO EASILY DURING CLEANING WITH THE TIP CLEANER. THE TIP DISAPPEARED INTRA-OP, THE NURSE AND SURGEON TRIED TO FIND IT. FINALLY THEY FOUND IT, BUT IT MADE TOO MUCH TIME WASTED (OP WAS DELAYED FOR 30MINS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037428 ↗
• MalfunctionApr 12, 2023Flaked; Detachment of Device or Device Component; Flaked; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SPINE PROCEDURE THE NURSE REPORTED THAT THE 0014AM TIP WAS IN GOOD CONDITION WHEN SHE OPENED IT FROM THE PACKAGING, BUT THE BLUE INSULATING PLASTIC WORE OFF DURING THE PROCEDURE. THE SURGEON SEARCHED AND COULD NOT FIND ANY DETACHED PIECES INSIDE PATIENT'S BODY (PATIENT IS STABLE AFTER SURGERY). THEY THEN OPENED ANOTHER 0014AM TIP FROM A DIFFERENT BATCH. THE SURGERY WAS PERFORMED USING 45W COAG MODE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723935 ↗
• MalfunctionApr 12, 2023Flaked; Detachment of Device or Device Component; Flaked; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SPINE PROCEDURE THE NURSE REPORTED THAT THE 0014AM TIP WAS IN GOOD CONDITION WHEN SHE OPENED IT FROM THE PACKAGING, BUT THE BLUE INSULATING PLASTIC WORE OFF DURING THE PROCEDURE. THE SURGEON SEARCHED AND COULD NOT FIND ANY DETACHED PIECES INSIDE PATIENT'S BODY (PATIENT IS STABLE AFTER SURGERY). THEY THEN OPENED ANOTHER 0014AM TIP FROM A DIFFERENT BATCH. THE SURGERY WAS PERFORMED USING 45W COAG MODE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723825 ↗
• InjuryNov 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BREAST AUGMENTATION THE SURGEON USED THE 0014AM HAND CONTROLLED MEGADYNE TIP. THE PIECE BECAME DETACHED DURING THE PROCEDURE AND THE PATIENT HAD TO BE REOPENED AND THE PIECE REMOVED. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE MISSING PIECE WAS NOTICED BY THE SCRUB NURSE - THE SURGEON REOPENED THE BREAST AND REMOVED IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED AND HAD TO BE REMOVED BY ANOTHER SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 15759128 ↗
• MalfunctionSep 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAMINECTOMY PROCEDURE THE INSULATED PART OF THE DIATHERMY TIP CAME OFF IN THE MIDDLE OF THE SURGERY AND WAS STUCK IN THE SUCTION TUBING. THE PROCEDURE WAS NOT DELAYED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE FRAGMENTS GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508096 ↗
• MalfunctionAug 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON USED E-Z CLEAN MODIFIED BLADE ON BLADDER OPERATION. DURING THE OPERATION, THE MODIFIED TIP (PART WHICH LOOKS LIKE STRAW ) FELL DOWN FROM THE INSTRUMENT. THE USER DIDN'T APPLY PRESSURE ON THE DEVICE DURING THE OPERATION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198197 ↗
• InjuryMay 23, 2022Human-Device Interface Problem; Material Integrity Problem; Human-Device Interface Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE THAT AT THE END OF THE CASE A BILATERAL ORAL COMMISSURE BURN WAS SUSTAINED DURING THE PROCEDURE. THE BURNS WERE SUSTAINED BECAUSE THE INSULATION ALONG THE SHAFT OF THE DEVICE HAD A DEFECT IN THE PLASTIC THAT ALLOWED CURRENT TO PASS THROUGH THE EDGE OF THE INSTRUMENT INSTEAD OF THE TIP. DEGREE OF THE BURN WAS NOT PROVIDED. ANOTHER DEVICE WAS NOT NEEDED TO COMPLETE THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 14469740 ↗
• MalfunctionMar 4, 2020Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 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 9788711 ↗
• MalfunctionApr 2, 2019Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN OPEN PROCEDURE, THE TIP OF THE 0014AM TOOK FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475679 ↗

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