Megadyne 0012MRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10614559100110), received between Nov 2, 2017 and Mar 4, 2026 — classified as 13 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (5 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BOVIE TIP WHERE PENCIL CAUTERY HOLDS THE TIP, THERE WAS A PERFORATION IN THE PROTECTIVE INSULATION OF THE TIP. WHEN USED IT CAME INTO CONTACT WITH THE PATIENT'S SKIN AND CREATED A MINOR BURN AT THE SURGICAL INCISION SITE. SURGEON WAS ABLE TO REMOVE AFFECTED AREA AT THE EDGE OF THE INCISION. IMMEDIATELY SWITCHED OUT BOVIE TIP. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Burn(s)

  MAUDE report 24507196 ↗
• MalfunctionOct 20, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE BOVIE TIP CAUSED A SMALL FLAME TO FORM. SURGEON INFORMED TECH AND CIRCULATOR WHAT OCCURRED. BOVIE TIP WAS TAKEN OFF THE FIELD AND A NEW BOVIE TIP WAS OPENED AND USED FOR THE REST OF THE CASE. COORDINATOR WAS CALLED TO THE ROOM TO BE INFORMED BY SURGEON WHAT OCCURRED. COORDINATOR TOOK BOVIE TIP OUT OF THE ROOM FOR FURTHER INVESTIGATION. PATIENT WASN'T HARMED FROM THE FIRE THAT THE BOVIE TIP CAUSED. IT WAS ON A MEGADYNE GENERATOR (SN (B)(6)) AND A MEGADYNE BOVIE PENCIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336524 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MEGADYNE EZ CLEAN ELECTRODE (0012M) BLUE INSULATED TIP DROPPED OUT DURING USE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182916 ↗
• MalfunctionFeb 11, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A PLASTICS CASE, A LAP PAD FIRE THAT WAS QUICKLY EXTINGUISHED AND THAT THERE WAS NO HARM TO THE PATIENT OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354011 ↗
• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RADICAL MASTECTOMY PROCEDURE THAT THE INSULATION ON THE BOVIE TIP FELL OFF IN THE PATIENT. FRAGMENT WAS RECOVERED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809720 ↗
• MalfunctionFeb 28, 2024Arcing of Electrodes; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST AUGMENTATION THAT THE DEVICE IS ARCHING A FLAME THAT BURNED THE PATIENTS NIPPLE. DEGREE OF BURN WAS NOT SPECIFIED BUT HEALTHCARE PROFESSIONAL INDICATED THAT IT WAS A "PRETTY SIGNIFICANT BURN". TREATMENT OF THE BURN WAS NOT PROVIDED.

  Patient problems: Burn(s); Partial thickness (Second Degree) Burn

  MAUDE report 18798362 ↗
• InjuryFeb 28, 2024Arcing of Electrodes; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST AUGMENTATION THAT THE DEVICE IS ARCHING A FLAME THAT BURNED THE PATIENTS NIPPLE. DEGREE OF BURN WAS NOT SPECIFIED BUT HEALTHCARE PROFESSIONAL INDICATED THAT IT WAS A "PRETTY SIGNIFICANT BURN". TREATMENT OF THE BURN WAS NOT PROVIDED.

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

  MAUDE report 18798067 ↗
• MalfunctionFeb 28, 2024Arcing of Electrodes; Human-Device Interface Problem; Arcing of Electrodes; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A BREAST AUGMENTATION THAT THE DEVICE IS ARCHING A FLAME THAT BURNED THE PATIENTS NIPPLE. DEGREE OF BURN WAS NOT SPECIFIED BUT HEALTHCARE PROFESSIONAL INDICATED THAT IT WAS A "PRETTY SIGNIFICANT BURN". TREATMENT OF THE BURN WAS NOT PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 18798060 ↗
• MalfunctionOct 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BLUE PROTECTIVE COVER LOOSEN AND DETACHED FROM MAIN BODY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913933 ↗
• InjuryMay 10, 2023Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT BACK IN 2020 THAT DURING AN EXCISION AND BIOPSY OF LESION AND REMOVAL OF IMPACTED WISDOM TEETH (2) THE CAUTERY SET AT 15 WATTS WAS USED TO SEPARATE THE TONSIL CAPSULE FROM THE MUSCLE ON THE LEFT SIDE OF THE MOUTH. A LEFT ORAL BURN WAS NOTED SHORTLY THEREAFTER. A WET GAUZE WAS IMMEDIATELY APPLIED. A CAUTERY WAS USED TO STOP THE BLEEDING. BACITRACIN WAS APPLIED. PHYSICIAN NOTIFIED THE PARENTS OF THE INCIDENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 16904376 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TONSILLECTOMY THE PATIENT RECEIVED A BURN, ON THE CORNER OF HER LIP, DURING A TONSILLECTOMY. THE BURN WILL SELF HEAL PER THE CUSTOMER.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 14853555 ↗
• InjuryJun 23, 2022Material 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 FACILITY STATED THAT THEY HAD A PATIENT BURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 14789691 ↗
• MalfunctionMay 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SPINE FUSION SURGERY, THE MODIFIED PART FELL OUT. IT TOOK ABOUT 30 MINUTES TO FIND THE MISSING PART, THE SURGERY WAS DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE FRAGMENTS GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489858 ↗
• InjuryAug 25, 2021Material 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 GENERAL CONSULTANT WAS PERFORMING A LOCAL EXCISION AND SENTINEL NODE OPERATION. THE PATIENT SUFFERED 2 BURNS TO THE AREOLA AREA - THIS WAS NOTICED BY THE ASSISTANT - WHO CHANGED THE TIP AND FINISHED THE CASE. IT WAS NOTICED THAT THERE WAS AN IMPERFECTION IN THE INSULATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 12367222 ↗
• MalfunctionApr 15, 2021Self-Activation or Keying; Human-Device Interface Problem; Self-Activation or Keying; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED RADICAL CYSTECTOMY AFTER THE LAPAROSCOPIC NEPHRECTOMY WAS COMPLETED, THE DEVICE FUNCTIONED PROPERLY AT THE EARLY PART OF THE PROCEDURE. 0012M,0039H AND VIO300D (ERBE) WAS USED TOGETHER. THEN UNTIL USING THE DEVICE AGAIN, THEY WERE PLACED TOGETHER IN A VINYL BAG WITH THE OTHER ENERGY DEVICE AND SUCTION/IRRIGATION DEVICE. LIQUID AND BLOOD LEAKING FROM THE SUCTION/IRRIGATION DEVICE HAD ACCUMULATED IN A VINYL BAG. THE DEVICES WERE SOAKED IN LIQUID. THEN THE ACTIVATION SOUND WAS HEARD FROM THE VINYL BAG WHEN THE SURGEON TRIED TO USE THE DEVICE AT THE LATTER PART OF THE OPERATION. AT THIS TIME, THE FOOTSWITCH OR THE HAND SWITCH WAS NOT PRESSED. THE SURGEON THOUGHT SOMETHING WAS WRONG, AND THE MEGADYNE CABLE WAS PLUGGED IN AND OUT FROM THE VIO 300D. THE POWER STOPPED FLOWING WHEN IT¿S PULLED OUT, BUT WHEN IT¿S PLUGGED IN, THE POWER FLOWED ON ITS OWN. WHILE THE SURGEON WAS PLUGGING IN AND OUT THE CABLE, THE TIP OF THE MEGADYNE WAS TOUCHING THE PATIENT¿S ABDOMEN, AND THE PATIENT GOT A BURN ABOUT 8CM LONG. THE DOCTOR INFORMED THE PATIENT'S FAMILY ABOUT THE BURN AND GAVE SOME OINTMENT TO TAKE CARE OF IT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673779 ↗
• InjuryNov 5, 2020Material 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 A BREAST SURGERY, THE MEGADYNE BOVIE TIP MELTED IN THE CENTER OF THE TIP (NOT THE COATED BLADE) AND MADE A SMALL BURN ON THE PATIENT'S BREAST NEAR THE INCISION. THE SURGEON EXCISED THE BURN TO INCLUDE IT IN THE INCISION AND CLOSED WITHOUT ANY OTHER ISSUES. ONE DEVICE WILL BE RETURNED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 10791583 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A SURGICAL BURN TO PATIENTS USING MEGADYNE INSULATED TIPS IN CONJUNCTION WITH COVIDIEN HANDPIECE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 9769893 ↗
• InjuryFeb 22, 2020Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A BREAST PROCEDURE, THE TIP WAS MEGADYNE 0012M, THE PENCIL WAS COVIDIEN AND THE DIATHERMY MACHINE WAS MARTIN. THE DIATHERMY SET AT 40/40 PURE CUT/SPRAY. SURGEON WAS WORKING DEEP IN THE BREAST WHEN HE NOTICED 2 OR 3 BURN MARKS ON THE OUTER BREAST TISSUE AT LEAST A FEW CMS AWAY FROM SURGICAL SITE. NO OBVIOUS MOMENT WHEN IT HAPPENED, NO SPARK/JUMP SEEN, UNKNOWN HOW LONG IT TOOK THEM TO NOTICE AS HANDS WERE HELPING TO HOLD THE BREAST. THEY ARE ALSO UNSURE OF IF IT HAPPENED WHILST USING CUT OR COAG. WHEN THEY LOOKED CLOSER AT THE TIP IT APPEARED TO ALSO HAVE A BURN TYPE MARK WHERE IT WAS CONNECTING INTO THE PENCIL. PATIENT CONSEQUENCE NOT REPORTED.

  Patient problems: Burn(s)

  MAUDE report 9742653 ↗
• InjuryAug 19, 2019Crack

  IT WAS REPORTED THAT DURING A BREAST PROCEDURE, THERE WAS A CRACK FOUND IN THE INSULATED PART OF THE TIP. THIS CAUSED THIRD DEGREE BURNS TO THE PATIENT UNDERGOING SURGERY. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 8907935 ↗
• InjuryAug 19, 2019Crack

  IT WAS REPORTED THAT DURING A BREAST PROCEDURE, THERE WAS A CRACK FOUND IN THE INSULATED PART OF THE TIP. THIS CAUSED THIRD DEGREE BURNS TO THE PATIENT UNDERGOING SURGERY. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 8907903 ↗
• InjuryAug 19, 2019Crack

  IT WAS REPORTED THAT DURING A BREAST AUGMENTATION THE PATIENT RECEIVED A SECOND DEGREE BURN. THE BURN WAS "HALF THE SIZE OF A DIME". SOME OF THE AREA THAT WAS BURNED WAS EXCISED AND THE REMAINING AFFECTED TISSUE WAS TREATED WITH OINTMENT. UPON INSPECTION THE CUSTOMER FOUND THAT THE BLUE INSULATION AT THE BASE OF THE ELECTRODE WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH A SECOND LIKE DEVICE.

  Patient problems: Burn(s)

  MAUDE report 8907400 ↗
• MalfunctionDec 3, 2018Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, A FEW MINUTES AFTER THE CASE STARTED, THE SURGEON BEGAN USING CAUTERY. THE SURGEON, PA, AND TECH ALL SAW A 2 INCH TALL FLAME FOR A BRIEF SECOND AND THEN IT WAS GONE. THE FLAME WAS IMMEDIATELY REPORTED TO THE OPERATING ROOM NURSE. THE BOVIE TIP THAT CAUSED THE FLAME DID NOT CAUSE DAMAGE TO THE PATIENT, BUT IT WAS REMOVED FROM THE FIELD AND A NEW BOVIE TIP WAS USED FOR THE REMAINDER OF THE CASE. THE BOVIE TIP THAT CAUSED THE FLAME WAS A 0012M MEGADYNE TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125625 ↗
• MalfunctionDec 3, 2018Fire

  A FEW MINUTES AFTER THE CASE STARTED, THE SURGEON BEGAN USING CAUTERY. THE SURGEON, (B)(6), AND TECH ALL SAW A 2 INCH TALL FLAME FOR A BRIEF SECOND AND THEN IT WAS GONE. THE FLAME WAS IMMEDIATELY REPORTED TO THE OR NURSE. THE BOVIE TIP THAT CAUSED THE FLAME DID NOT CAUSE DAMAGE TO THE PATIENT, BUT IT WAS REMOVED FROM THE FIELD AND A NEW BOVIE TIP WAS USED FOR THE REMAINDER OF THE CASE. THE TIP WAS SENT TO CLINICAL ENGINEERING AND WILL BE RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS. MANUFACTURER RESPONSE: FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, MEGADYNE (PER SITE REPORTER): CUSTOMER SUPPORT WAS CONTACTED. THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS. ANY FURTHER CONTACT WILL BE SHARED WITH MEDSUN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8124203 ↗
• InjuryNov 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SECONDARY BURN UTILIZING A 0012M WITH A MEDLINE PENCIL IS AN ENT PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 6996780 ↗

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