Megadyne 0012AMRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10614559100103), received between Oct 23, 2018 and May 20, 2026 — classified as 7 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 18, 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.

• MalfunctionMay 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NEURO CASE THE TIP INSULATION FELL OFF WHEN IN USE - INTO THE PATIENT. INSULATION TIP WAS RETRIEVED FROM THE PATIENT AND ANOTHER UNIT OPENED. THE PROCEDURE WAS DELAYED BUT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233451 ↗
• InjuryApr 6, 2026Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY PROCEDURE, THE CAUTERY WAS NOT ACTIVATING AND MISFIRING. AT START OF CASE ALL CONNECTIONS CHECKED BY CIRCULATOR, SCRUB NURSE AND SURGEON TOLD TO CHECK CAUTERY TIP CONNECTION SURGEON REMOVED AND REINSERTED THE TIP AS A RESPONSE TO THIS. PATIENT UNDERWENT SURGERY AND ONCE DAVIS-BOYLE GAG WAS RELEASED, SURGEON IDENTIFIED SIGNIFICANT PARTIAL TO FULL THICKNESS BURNS TO THE CORNERS OF THE PATIENT'S MOUTH BILATERAL THAT HAD BEEN CAUSED DURING SURGERY. SURGEON IMMEDIATELY APPLIED SALINE-SOAKED GAUZE TO THE AREA. PLASTIC SURGERY WAS MADE AWARE AND STAFF BROUGHT INTO ROOM TO EXAMINE THE AREA AND WILL FOLLOW PATIENT. PLASTICS CAME TO THE ROOM, COMPLETED AN ASSESSMENT, TOOK PHOTOGRAPHS, AND RECOMMENDED ADMISSION OF THE PATIENT. SITE CLEANSED WITH STERILE NS, DRIED, AND POLYPORE OINTMENT APPLIED TO AREAS BY EAR, NOSE, AND THROAT SURGEON.

  Patient problems: Burn(s)

  MAUDE report 24793004 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE BLUE INSULATION CAME OFF DURING USE. THE PRODUCT WAS A COMPONENT OF A KIT PACK FROM JAPAN MEDICAL PRODUCTS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512999 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE SURGEON ENTERED TO ASSIST WITH DEVICE RELATED CONCERN DURING AN UNKNOWN SURGERY WHERE IT WAS IDENTIFIED INTRA-OP THAT CAUTERY TIP HAD CREATED A BURN ON THE PATIENT'S RIGHT CHEST.

  Patient problems: Burn(s)

  MAUDE report 23864197 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST SURGERY THE SURGEON EXPERIENCED A BURN WHEN USING MEGADYNE SMOKE EVAC PENCIL (251010J AND 0012AM) DURING A CASE. IT HAPPENED WHEN SHE WAS TRYING TO BUZZ SOFT TISSUE BY TOUCHING THE DIATHERMY PENCIL TO THE FORCEPS. THE SURGEON WAS HOLDING THE FORCEPS WHILE HER ASSISTANT WAS TOUCHING THE DIATHERMY TO THE FORCEPS. ATTACHED PHOTOS OF HER BURN. DIATHERMY SETTINGS ARE AS FOLLOW: CUT 20 AND COAG 25. DIATHERMY PAD WAS VALLEYLAB CQM DIATHERMY PAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 20619864 ↗
• MalfunctionOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN OPEN SURGERY, THE BLUE COVER PART OF THE TIP DETACHED DURING USE, SO USE WAS STOPPED. NO PIECES WERE LEFT INSIDE THE PATIENT. THE GENERATOR WAS COMPETITIVE ONE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THE BLUE COVER AT THE TIP CAME OFF OUTSIDE THE PATIENT. THERE WAS NO BLEEDING AND NO TISSUE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343435 ↗
• MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN OPEN HEART SURGERY, THE BLUE COVER PART OF THE TIP DETACHED DURING USE, SO USE WAS STOPPED. NO PIECES WERE LEFT INSIDE THE PATIENT. THE GENERATOR WAS COMPETITIVE ONE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THE BLUE COVER AT THE TIP CAME OFF OUTSIDE THE PATIENT. THERE WAS NO BLEEDING AND NO TISSUE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223292 ↗
• MalfunctionJul 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED WHEN THE DEVICE WAS TO BE USED AT THE FACTORY, IT WAS REPORTED THAT THERE WAS A PART THAT IT WAS NOT SEALED BECAUSE MEGA CHIP WAS CAUGHT IN THE SEALED PORTION OF AN INDIVIDUAL PACKAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700770 ↗
• MalfunctionJul 9, 2024Flaked; Detachment of Device or Device Component; Flaked; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE, THE COATING ON TIP OF THE ELECTRIC SCALPEL PEELED OFF DURING USING THE DEVICE. IT WAS REPORTED BY AGENCY. THE BLACK THING LIKE RUBBER COVERING THE TIP HAD COME OFF. THERE WERE NO PIECES LEFT IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THE BLACK PART WHICH COVERED THE TIP OF THE DEVICE WAS DETACHED. THE BROKEN PIECES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700128 ↗
• MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE TIP OF THE DEVICE CAME OFF IN USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19151723 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT DURING A TONSILLECTOMY, THEY WERE USING A COVIDIAN BOVIE, INSERTED THE TIP BUT WAS NOT PUSHED IN CORRECTLY/ENTIRELY. THE EXPOSED METAL PORTION CAUSED THE BURN OF THE PATIENT AROUND THE LIPS/MOUTH. PATIENT WAS TAKEN CARE OF WITHOUT FURTHER ISSUES. CUSTOMER CONFIDENT IT ISN'T THE PRODUCT'S ISSUE FOR THE CAUSE BUT WANTED TO CALL IT IN FOR THEIR STANDARD PROTOCOLS. DEVICE IS AVAILABLE FOR RETURN.

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

  MAUDE report 18807682 ↗
• MalfunctionJan 30, 2024Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN RIGHT BREAST EXCISIONAL BIOPSY PROCEDURE THERE WAS A SMALL FIRE DUE TO BOVIE TIP. WHILE THE SURGEON WAS USING THE INSULATED BOVI FOR CAUTERY, IT CONNECTED WITH THE ADSON FORCEP. A SPARK FLEW AND LANDED ON A NEARBY RAYTEC. SMOKE STARTED TO COME FROM THE RAYTEC. SHE GRABBED THE RAYTEC, PLACED IT ON FLOOR AND STEPPED ON IT TO PUT OUT. THE PATIENT WAS UNHARMED. WE PULLED THE BOVI TIP THAT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606677 ↗
• InjuryJun 6, 2023Failure to Disconnect; Adverse Event Without Identified Device or Use Problem; Failure to Disconnect; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO A TONSILLECTOMY THAT A PATIENT INCURRED A BURN DURING A PROCEDURE IN WHICH A MEDTRONIC PENCIL WAS USED WITH A MEGADYNE TIP (EITHER CODE 0012M OR 0012AM ¿ STILL WORKING TO OBTAIN DETAILS). THE CUSTOMER SHARED THAT THEY CONSIDERED HUMAN ERROR SO THEY OPENED ANOTHER PACK WITH THE SAME PENCIL TIP COMBINATION AND WERE UNABLE TO SECURELY SEAT THE TIP AND ALSO NOTED THAT IT FELT ¿LOOSE¿.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 17069982 ↗
• InjuryFeb 2, 2023Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE RIGHT AFTER USE WHEN THE DIATHERMY TIP WAS NOT ACTIVATED, HCP WAS PUTTING THE PENCIL DOWN WHEN IT BRUSHED AGAINST HER ASSISTANT¿S GOWN AND BURNT THROUGH HIS GOWN AND HE SUFFERED MINOR BURNS ON HIS FOREARM. THE ASSISTANT IS NOW FINE, MEDICAL TREATMENT WAS SOUGHT IMMEDIATELY. HCP ALSO MENTIONED WITNESSING SPARKS AT THE JUNCTURE WHERE THE DIATHERMY TOUCHES THE FORCEPS DURING USE. THE SETTINGS OF THE ESU ARE AS FOLLOWS: CUT 20 AND COAG 35.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 16283131 ↗
• InjuryFeb 1, 2022Arcing 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 PROCEDURE OF THE EXCISION OF THE THERAGLOSSAL DUCT CYST. THE SURGEON WAS USING THE ULTRAVAC SMOKE EVACUATION PENCIL 211010EC WITH THE 012AM MEGADYNE PENCIL TIP. WHEN THE SURGEON WENT TO ACTIVATE THE DEVICE THROUGH AN INCISION OF ROUGHLY 2CM, THE ULTRAVAC PENCIL WAS ACTIVATE USING THE COAG BUTTON ON THE CRICOID CARTILAGE THE SURGEON SAID THE 012AM PENCIL TIP ARCED AND A BURN OCCURRED ROUGHLY .5CM ON THE OUTSIDE OF THE INCISION ON THE NECK AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Partial thickness (Second Degree) Burn

  MAUDE report 13414065 ↗
• MalfunctionJan 13, 2022Fire; Arcing of Electrodes; Fire; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT IGNITED WHILE IN USE. THERE WAS FLAME PRESENT. CASE COMPLETED BY SWITCHING THE TIP. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252434 ↗
• MalfunctionJun 22, 2021Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A TONSILLECTOMY ON (B)(6) 2021. THE PROCEDURE WAS UNCOMPLICATED. AT THE END OF THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD BURN INJURIES TO BOTH THE RIGHT AND LEFT SIDES OF THE ORAL COMMISSURE. A LITERATURE REVIEW OF ORAL BURNS DURING ELECTROCAUTERY TONSILLECTOMY INDICATED THAT INADVERTENT ORAL CAVITY BURNS COULD OCCUR FROM ELECTROCAUTERY DEVICES. IT IS POSSIBLE THAT THE ELECTROCAUTERY ELECTRODE TIP HAD BECOME DISLODGED/LOOSENED. THIS WOULD LEAVE AN UNINSULATED PORTION OF THE ELECTRODE TIP EXPOSED WHICH COULD POTENTIALLY COME IN CONTACT WITH THE PATIENT'S ORAL TISSUE ALLOWING ARCHING OF THE ELECTRICAL CURRENT AND CAUSING THE BURNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041148 ↗
• MalfunctionJul 23, 2020Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A BREAST AUGMENTATION, THE "CAUTERY TIP IS DEFECTIVE. THERE WAS A SPARK WHEN THE DOCTOR USED IT IN THE OPERATING ROOM, PATIENT WAS BURNT." CUT 40 COAG 35. A VALLEY LAB GENERATOR WAS USED AND THE PREP SOLUTION USED WAS BETADINE. THE SOLUTION WAS NOT RINSED OFF AND DID NOT POOL UNDER THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313880 ↗
• MalfunctionDec 6, 2019Device Dislodged or Dislocated

  IT WAS REPORTED BY THE DISTRIBUTOR DURING AN UNKNOWN PROCEDURE THAT WHEN CHANGING THE CAUTERY TIP, THE BLUE PLASTIC PIECE BECAME DISLODGED AND FREE. IT IS UNKNOWN IF THERE WERE ANY ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9433889 ↗
• MalfunctionDec 6, 2019Device Dislodged or Dislocated

  IT WAS REPORTED BY THE DISTRIBUTOR DURING AN UNKNOWN PROCEDURE THAT WHEN CHANGING THE CAUTERY TIP, THE BLUE PLASTIC PIECE BECAME DISLODGED AND FREE. IT IS UNKNOWN IF THERE WERE ANY ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9433723 ↗
• MalfunctionOct 28, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, A FOREIGN MATTER LIKE SOMEONE¿S HAIR WAS ADHERED TO TAPE SEALING PACKAGE. 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 9247861 ↗
• MalfunctionAug 29, 2019Flare or Flash

  IT WAS REPORTED THAT DURING A MASS EXCISION THERE WAS A FLASH AS THE SURGICAL SITE FROM EITHER THE PENCIL OR THE TIP. IT IS UNKNOWN HOW THEY FINISHED THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946945 ↗
• MalfunctionAug 19, 2019Fire; Sparking

  (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907633 ↗
• MalfunctionOct 23, 2018Material Separation

  (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997618 ↗

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