Megadyne 0013MRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10614559100134), received between Sep 14, 2018 and Mar 26, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (11 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.

• MalfunctionMar 26, 2026Arcing of Electrodes

  IT WAS REPORTED THAT THE INCIDENT OCCURRED INTRA-OPERATIVELY DURING AN UNKNOWN PROCEDURE. WHILE THE SURGEON WAS ACTIVATING A MONOPOLAR PENCIL, THE BOVIE TIP SUDDENLY CAUGHT FIRE. THE PATIENT WAS NOT INJURED. THE BOVIE TIP WAS REMOVED, BOVIE PENCIL DISCARDED, AND A NEW BOVIE PENCIL WAS OPENED AND USED FOR THE REMAINDER OF THE CASE. THE ITEM AVAILABLE FOR RETURN IS THE BURNT BOVIE TIP. THERE WAS 10MINS OF SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703709 ↗
• MalfunctionJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON HAD AN ISSUE WITH THE CURRENT PROTECTED NEEDLE CAUTERY TIP A FEW WEEKS AGO, AND IS JUST NOW REPORTING. SURGEON WAS DOING A FACE CASE AND THE SETTINGS WERE ONLY 20-25 FOR CUT AND COAG. THE METAL TIP MELTED OFF. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123348 ↗
• MalfunctionJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON HAD AN ISSUE WITH THE CURRENT PROTECTED NEEDLE CAUTERY TIP A FEW WEEKS AGO AND IS JUST NOW REPORTING. SURGEON WAS DOING A FACE CASE AND THE SETTINGS WERE ONLY 20-25 FOR CUT AND COAG. THE METAL TIP MELTED OFF. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123330 ↗
• MalfunctionMar 12, 2024Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY WHEN THE ELECTROSCALPEL IS ACTIVATED, A FLAME IS PRODUCED IN THE PROTECTED PEDIATRIC TIP. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884843 ↗
• MalfunctionFeb 9, 2024Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A RADIAL REPAIR PROCEDURE THAT WHILE REMOVING A SENTINEL IMPLANT THAT THE BOVIE TIP FLAMED UP BEING USED WITH A COMPETITOR'S PENCIL AND A MEGEN1 GENERATOR. THE BOVIE TIP, PENCIL AND GENERATOR WERE REPLACED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676031 ↗
• MalfunctionJan 11, 2024Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING THE REMOVAL OF INFECTED HARDWARE THAT WHILE USING COAG ON SETTING OF 30/30 ALONG WITH A METAL FORCEPS THE BOVIE TIP CAUGHT FIRE BUT DID NOT SPARK. THE TIP WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH THE SAME PENCIL AND GENERATOR. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT, SURGEON, AND STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491944 ↗
• MalfunctionJan 2, 2024Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE CUSTOMER STATED THAT A BOVIE TIP CAUGHT ON FIRE. CUSTOMER STATED THAT THE BLACK PROTECTIVE TIP HAD CAUGHT ON FIRE. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425407 ↗
• MalfunctionNov 9, 2023Flaked; Detachment of Device or Device Component; Flaked; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE THE BOVIE TIP BEGAN FALLING APART DURING THE PROCEDURE, THE SCRUB TECH IN THE ROOM NOTICED THAT IT APPEARED TO BE GETTING SHORTER AND THEN AS SHE WIPED THE TIP OFF PART OF IT BROKE OFF. SCRUB TECHNICIAN IMMEDIATELY REMOVED THE BOVIE TIP FROM THE FIELD AND REQUESTED A NEW ONE. BOVIE TIP WAS GIVEN TO ETHICON REP FOR TESTING. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18101167 ↗
• MalfunctionSep 28, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE FACILITY DISPOSED OF ONE DEVICE BECAUSE THE STERILE PACKAGE WAS COMPROMISED OUT OF THE CASE. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834185 ↗
• MalfunctionFeb 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PLASTIC SURGERY PROCEDURE WHICH ARE TAKING LONGER, THE ISOLATING TIP BREAKS OFF. PARTS FELL INTO THE PATIENT AND HAD TO BE REMOVED DURING THE SAME PROCEDURE (NO ADDITIONAL SURGERY NEEDED). NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375398 ↗
• MalfunctionFeb 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE INSULATOR TIP FELL OUT FROM THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326625 ↗
• MalfunctionDec 28, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE CAUTERY WAS BEING APPLIED TO PATIENT VIA SURGEON TOUCHING THE CAUTERY TIP TO THEIR TISSUE FORCEPS. SURGICAL TEAM THEN NOTED THAT THE CAUTERY TIP WAS FLAMING. CAUTERY TIP REMOVED AND SAME CHARRED. CAUTERY TIP REPLACED. THERE WERE NO SURGICAL DELAY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060544 ↗
• MalfunctionNov 9, 2022Arcing of Electrodes; Human-Device Interface Problem; Arcing of Electrodes; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A SPARK OCCURRED DURING SURGERY AT THE SITE OF DAMAGE TO THE OUTER SURFACE OF THE ELECTRODE. BURNS TO THE PATIENT'S SKIN THE SURGERY WAS DELAYED 30 MINUTES TO STOP AND REPLACE THE ELECTRODE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT SUFFERED FROM A BURN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15758887 ↗
• MalfunctionSep 29, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE CAUGHT FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508115 ↗
• MalfunctionSep 29, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE CAUGHT FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508093 ↗
• MalfunctionSep 29, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE CAUGHT FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508024 ↗
• MalfunctionAug 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE INSULATOR OF THE TIP WAS PEELED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320824 ↗
• MalfunctionJan 21, 2021Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A THYROIDECTOMY, WHEN CONTACTING THE THYROID AFTER TISSUE DETACHMENT, A SPARK OCCURS AT THE TIP OF THE MEGADYNE MODIFIED NEEDLE ELECTRODE 0013M AND THE BOVIE TIP IS BURNED AND BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207267 ↗
• MalfunctionAug 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE 0013M WAS BEING USED WITH THE CONMED 2450 & 0035H PENCIL. THE INSULATION PART OF 0013M BROKE. THE GENERATOR POWER AT THAT TIME WAS 40W. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459459 ↗
• MalfunctionNov 8, 2019Fire; Sparking

  IT WAS REPORTED THAT DURING A THYROIDECTOMY, THE NEEDLE TIP SPARKED AND CAUGHT ON FIRE. A SECOND LIKE TIP WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9298512 ↗
• MalfunctionNov 4, 2019Fire

  IT WAS REPORTED THAT DURING A THYROIDECTOMY THE ELECTRODE TIP CAUGHT ON FIRE AND WAS BURNING LIKE A MATCH. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9276105 ↗
• MalfunctionJun 7, 2019Fire; Sparking

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY, WHILE THE PRODUCT WAS IN USE OUTSIDE THE PATIENT THE TIP SPARKED AND FLAMED. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679000 ↗
• MalfunctionMar 16, 2019Fire; Melted

  IT WAS REPORTED THAT DURING A PROCEDURE TO REMOVE THE SUBMANDIBULAR SALIVARY GLAND, THERE WAS A DISPOSABLE BOWA DIATHERMY HANDPIECE WITH MEGADYNE SHORT SPIKE TIP (E-Z CLEAN). DURING THE OPERATION WHILE SURGERY USED DIATHERMY DEVICE, THE TIP OF THE SPIKE (NEEDLE ELECTRODE/REF. 0013M) CAME ON FIRE. THE TIP HAD VISIBLE FLAMES AND THE TIP PLASTIC PART BLACKED AND MELTED. THERE WAS A SMELL OF BURNT PLASTIC IN THE ROOM. THE FLAMES TURNED OFF THEMSELVES. THE PATIENT DID NOT SUFFER ANY BURNS. THE DIATHERMY DEVICE HAD NORMAL SETTINGS. A NEW TIP WAS EXCHANGED FOR DIATHERMY DEVICE, FOLLOWED BY NORMAL USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426848 ↗
• MalfunctionSep 14, 2018Fire; Sparking

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE SURGEON WAS USING A COVIDIEN FT10 ELECTROSURGICAL GENERATOR UNIT (ESU) SERIAL # (B) (4) AND A MEGADYNE BOVIE NEEDLE TIP-LOT #183471 AND ENCOUNTERED A SPARK AND A SMALL FLAME IN THE OPERATING ROOM. STAFF REMOVED THE TIP AND REPLACED IT WITH A REGULAR MEGADYNE BOVIE TIP- LOT# 180191 AND AGAIN ENCOUNTERED SPARKS AND A SMALL FLAME. STAFF REMOVED THE ESU UNIT AND NO ADDITIONAL SPARKS OR FLAME OCCURRED. THE INITIAL UNIT WAS SET AT THIRTY CUT AND THIRTY COAG WHEN THE SPARK OCCURRED. THEN, THE UNIT WAS TURNED DOWN TO TWENTY CUT AND TWENTY COAG WITH THE SAME RESULT. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877539 ↗

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