MEGADYNE 251010JRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10614559105573), received between Jun 28, 2021 and Mar 26, 2026 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Flaked” (11 reports).

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Flaked

  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. THERE WAS 10 MINS OF SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703964 ↗
• MalfunctionFeb 27, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A THYROID INCISION PROCEDURE, THE SURGEON REPORTED AN INCIDENT INVOLVING THE ELECTROSURGICAL PENCIL (BOVIE). THE SURGEON STATED THAT WHILE SHE WAS USING THE BOVIE AND WENT TO SET IT DOWN, SHE FELT A TINGLING SENSATION IN HER ARM. SHE THEN LOOKED DOWN AND OBSERVED THAT THE BOVIE WAS ACTIVATED EVEN THOUGH SHE WAS NOT PRESSING ANY BUTTONS. A BURN HOLE WAS NOTED ON THE SLEEVE OF HER SURGICAL GOWN. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470156 ↗
• MalfunctionMar 28, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A COLOSTOMY TAKE DOWN PROCEDURE THAT A DRY SPONGE CAUGHT ON FIRE AFTER ENERGY FROM THE TIP OF THE PENCIL "ARC'D" TOWARDS THE SPONGE DURING A PROCEDURE INVOLVING A MEGEN1 AND TELESCOPING SMOKE PENCIL (10 FT). THE DRY SPONGE WAS REPORTEDLY 2 INCHES AWAY FROM THE TIP OF THE PENCIL WHILE ACTIVATING. THE BRAND OF SMOKE EVACUATOR WAS NOT REPORTED ON THE CALL. THE CUSTOMER SENT THE MEGEN1 TO BIOMED FOR TROUBLESHOOTING BUT THEY THREW AWAY THE GROUNDING PAD AND TELESCOPING PENCIL. NO PATIENT CONSEQUENCE OR PROCEDURE DELAY REPORTED. BIOMED'S CONFIRMED THE POWER OUTPUT WAS MEASURING IN RANGE AT 35 WATTS FOR CUT AND COAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719215 ↗
• InjuryNov 6, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  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. 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 20619983 ↗
• MalfunctionOct 29, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A BREAST SURGERY THAT THERE WAS A "FLAME LIKE EFFECT" COMING FROM THE BOVIE. GENERATOR SETTINGS WERE CHANGED SEVERAL TIME BUT IT CONTINUED. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. PENCIL RETURNING AND POSSIBLY THE GENERATOR ONCE FACILITY BIOMED HAS DONE THEIR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560410 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO A PANNICULECTOMY CASE THE PATIENT HAD ISSUES WITH POSTOPERATIVE BLEEDING. THE SURGEON HAD RECENTLY ADOPTED THE MEGADYNE SMOKE EVACUATION PENCIL, AND IS CONCERNED THAT IT MAY BE A FACTOR IN THE COMPLICATIONS. PATIENT DID REQUIRE REVISION SURGERY OR HARDWARE REMOVAL.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19922459 ↗
• InjuryMay 23, 2024Failure to Disconnect; Difficult or Delayed Activation; Failure to Disconnect; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PRODUCT FAILED DURING A SURGERY, SOMEHOW THE SURGEON WAS WORKING INSIDE THE ANIMAL AND HE WAS SHOCKED BY THE BOVIE PENCIL. THE SURGEON HAD TO CANCEL CASES DUE TO HIS INJURY.

  Patient problems: Inflammation; Partial thickness (Second Degree) Burn; Shock

  MAUDE report 19381753 ↗
• MalfunctionFeb 22, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WERE SPARKS AND FLAMES AT THE DISTAL END OF THE BOVIE WHILE USING THE COAG FUNCTION. THE BOVIE POWER SETTINGS WERE 30/30 AND THE BOVIE WITH THE ELECTRODE WERE SAVED. THERE WERE OTHER INSTRUMENTS IN THE SURGICAL SITE AT THE TIME THIS OBSERVATION WAS MADE BY THE SURGEON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760249 ↗
• MalfunctionFeb 16, 2024Flaked; Flaked

  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 18720523 ↗
• MalfunctionJan 2, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE 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 18425202 ↗
• InjuryNov 9, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A LUNG WEDGE RESECTION PROCEDURE THAT WHILE USING A BOVIE THE SURGEON HAD HIS FINGER UNDER SOME TISSUE WHILE CUTTING AND CAUTERIZING AND USUALLY HE CAN FEEL THE HEAT GETTING STRONGER THE CLOSER HE GETS TO HIS FINGER BUT THIS TIME HE DID NOT FEEL IT TILL HE HAD HIT HIS INDEX FINGER RESULTING IN A BLISTER AND A THIRD DEGREE BURN. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. SURGEON CONFIRMED THAT HE DID NOT HEAR ANY WARNINGS DURING THE CASE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 18101342 ↗
• MalfunctionNov 2, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE LOADING DOCK RECEIVED THEIR ORDER LAST WEEK THEY RECEIVED ONE DAMAGED BOX OF SMOKE EVACUATION PENCILS. CUSTOMER STATED THAT THEY WOULD HAVE KEPT THEM BUT THE PRODUCT PACKAGING IS ALSO DAMAGED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054953 ↗
• MalfunctionOct 2, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN THE LOADING DOCK RECEIVED THEIR ORDER LAST WEEK THEY RECEIVED ONE DAMAGED BOX OF SMOKE EVACUATION PENCILS. CUSTOMER STATED THAT THEY WOULD HAVE KEPT THEM BUT THE PRODUCT PACKAGING IS ALSO DAMAGED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850582 ↗
• InjuryFeb 2, 2023Flaked; Difficult or Delayed Activation; Flaked; Difficult or Delayed Activation

  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 16282990 ↗
• MalfunctionDec 21, 2022Adverse Event Without Identified Device or Use Problem; Complete Loss of Power; Adverse Event Without Identified Device or Use Problem; Complete Loss of Power

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE THAT WHILE THE DEVICE WAS LAID DOWN AND NOT IN USE IT SELF-ACTIVATED BURNING THROUGH THE SURGEONS GOWN AND BURNING HIS ARM. UNKNOWN AS TO WHAT DEGREE OF BURN TO THE SURGEONS ARM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 16023848 ↗
• InjuryOct 20, 2022Flaked; Difficult or Delayed Activation; Flaked; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING THE EXCISION OF TEMPORAL MASS PROCEDURE, THE SURGICAL DRAPE CAUGHT FIRE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT WAS MOVED TO A BURNED HOSPITAL AND IS NOW IN ICU.

  Patient problems: Burn(s)

  MAUDE report 15640285 ↗
• MalfunctionAug 30, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE THAT THE DEVICE WAS PLUGGED INTO THE GENERATOR THE SURGEON ACTIVATED THE DEVICE AND AN INCH AND A HALF FROM THE PATIENT AND A ¿BALL OF FLAME¿ APPEARED AT THE TIP OF THE DEVICE. THE ENTIRE SET UP INCLUDING THE GENERATOR, GROUNDING PAD, HANDPIECE AND PENCIL WERE REPLACED TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319377 ↗
• InjuryApr 26, 2022Flaked; Difficult or Delayed Activation; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Flaked; Difficult or Delayed Activation; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BACK PROCEDURE WHILE LYING ON THEIR SIDE THE PATIENT EXPERIENCED A BURN THROUGHOUT THE FACE AS A RESULT OF A FIRE CAUSED BY THE DEVICE. THE PLASTIC EXTENDER ON THE DEVICE HAD MELTED AND WAS CHARRED.

  Patient problems: Burn(s)

  MAUDE report 14205366 ↗
• MalfunctionApr 21, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE, A STRYKER ELECTRODE WAS PUT INTO THE MEGADYNE 251010J SMOKE EVACUATION PENCIL. SPARKING WAS OBSERVED BY THE SURGEON AND TECH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166287 ↗
• MalfunctionMar 2, 2022Difficult or Delayed Activation; Appropriate Device Problem Term/Code Not Available; Difficult or Delayed Activation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A COLORECTAL CASE THE ACTIVATION BUTTON GOT STUCK ON THE ON POSITION CAUSING THE DEVICE TO CONTINUOUSLY ACTIVATE. A NEW CONSUMABLE WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652070 ↗
• MalfunctionJun 28, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE UNIT WILL CONTINUOUSLY RUN. DOES NOT SYNC ACTIVATE ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12074535 ↗