MEGADYNE MEGEN1Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10614559105597), received between Nov 8, 2021 and May 19, 2026 — classified as 15 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (27 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Self-Activation or Keying; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE AUTOMATIC BIPOLAR MODE IS ACTIVATED, IT ACTIVATES WITHOUT BRINGING IT CLOSE TO THE TISSUE AND GENERATES A DETECTION SOUND. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217138 ↗
• MalfunctionMay 18, 2026Self-Activation or Keying

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE DEVICE ACTIVATES WITHOUT PROMPT AND IT INJURED THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 25211518 ↗
• InjuryMar 30, 2026Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY WERE PERFORMING A PACEMAKER SURGERY ON A PATIENT WHEN A FIRE STARTED, CAUSING BURNS TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 24720544 ↗
• MalfunctionMar 6, 2026Failure to Read Input Signal; Difficult or Delayed Activation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MEGEN1 MACHINE NOT WORKING PROPERLY. NO CLINIC CONSEQUENCE LIKE INFECTION OR INFLAMMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536276 ↗
• InjuryDec 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A DIATHERMY INJURY OCCURRED WHEN USING IT, DESPITE DEVICES NOT SHOWING ANY VISUAL DEFECT.

  Patient problems: Burn(s)

  MAUDE report 23804571 ↗
• MalfunctionMar 28, 2025Arcing of Electrodes; Arcing of Electrodes

  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 21719214 ↗
• MalfunctionMar 19, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE AUTO BIPOLAR IS ACTIVATING ON IT'S OWN WHILE USING A MEDTRONIC INSTRUMENT WITH FLYING LEADS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641815 ↗
• MalfunctionMar 6, 2025Failure to Read Input Signal; Difficult or Delayed Activation; Failure to Read Input Signal; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ISSUE HAS RECURRED WHERE THE SENSOR ON THE PLATE ACTIVATES BY ITSELF WITHOUT ANY CABLE CONNECTED. ON (B)(6), IT WAS REPORTED THAT THERE WAS AN "ERROR ON THE SCREEN WITH CODE 121 12, AND THE PATIENT RETURN CABLE OCCASIONALLY ACTIVATES EVEN WHEN IT IS NOT CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535005 ↗
• MalfunctionMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CADAVER LAB THE BOVIE WERE AROUND 30 CUT 30 COAG. THE SURGEON GOT BURNED THROUGH THEIR GLOVES.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21528879 ↗
• MalfunctionMar 5, 2025Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CADAVER LAB THE BOVIE WERE AROUND 30 CUT 30 COAG. THE SURGEON GOT BURNED THROUGH THEIR GLOVES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Partial thickness (Second Degree) Burn

  MAUDE report 21528749 ↗
• MalfunctionMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CADAVER LAB THE BOVIE WERE AROUND 30 CUT 30 COAG. THE SURGEON GOT BURNED THROUGH THEIR GLOVES.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21528636 ↗
• 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 21357981 ↗
• MalfunctionFeb 3, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE THAT IT WAS FOUND THAT WHEN THE UNIT IS POWERED ON THE UNIT IS SELF ACTIVATING EVEN WHEN THERE IS NO EQUIPMENT INCLUDING THE FOOTPEDAL PLUGGED IN TO THE UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290936 ↗
• MalfunctionJan 28, 2025Arcing of Electrodes; Arcing of Electrodes

  PER USER FACILITY MEDWATCH FORM, #(B)(4) DURING PANNICULECTOMY PROCEDURE, MID-SURGICAL CASE, WHILE THE SURGICAL TEAM WAS DISSECTING ABDOMINAL FAT OFF THE FASCIA USING A BOVIE AND LAP PAD, A FIRE OCCURRED. PER INTERVIEWS OF THE TEAM PRESENT, WHILE ACTIVELY USING THE BOVIE AND LAP PAD TO CONTROL BLEEDING, THEY SAW A SPARK/'LIGHTNING BOLT' FROM THE BOVIE, AND THEN THE LAP PAD STARTING TURNING BROWN AND A FLAME APPEARED ON THE LAP PAD. THE LAP PAD WAS IMMEDIATELY THROWN TO THE FLOOR, AND WATER FROM THE BACK TABLE WAS POURED ON THE LAP PAD TO EXTINGUISH THE FLAME. THERE WAS NO INJURY TO THE PATIENT OR ANY TEAM MEMBER. THE BOVIE PEN WAS DISPOSED, BUT THE GENERATOR IS AVAILABLE AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252569 ↗
• MalfunctionJan 22, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS GENERATED WITH A MEGADYNE EQUIPMENT IN THE CLIENT IQ SERIES OF THE EQUIPMENT (B)(6), THE EQUIPMENT GENERATES AUTOMATIC ACTIVATION WITHOUT THE DOCTOR ACTIVATE THE PEN OR PEDAL, CHANGE OF CONSUMABLE IS MADE AND THE PROBLEM PERSISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207277 ↗
• MalfunctionDec 31, 2024Arcing of Electrodes; Human-Device Interface Problem; Arcing of Electrodes; Human-Device Interface Problem

  IT WAS REPORTED THAT THEY WERE REMOVING A LESION/CYST FROM THE PATIENT'S NECK AT AN AMBULATORY SURGERY SITE. WHEN THE UNIT WAS BEING ACTIVATED THE STERILE DRAPES CAUGHT FIRE AND THE FIRE SPREAD TO THE PATIENT. THEY PUT THE FIRE OUT AND PATIENT WAS TAKEN TO LOCAL EMERGENCY ROOM BY AMBULANCE, PATIENT SUSTAINED BURNS. THAT IS ALL THE INFORMATION KNOWN TO THE BIOMED AT THIS TIME.

  Patient problems: Burn(s)

  MAUDE report 21047072 ↗
• MalfunctionDec 12, 2024Failure to Read Input Signal; Difficult or Delayed Activation; Failure to Read Input Signal; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MEGADYNE GENERATOR, FIRST USE OF NEW MACHINE. AUTO BIPOLAR ALARMING CONSTANTLY AND ACTIVATING ENERGY WHEN SITTING ON THE TABLE, NOT IN USE. THE SURGERY WAS DELAYED 30 MINUTES. TURNED OFF AUTO WHEN NOT IN USE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912707 ↗
• MalfunctionDec 9, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE WHEN USING BIPOLAR AUTO MODE, THE GENERATOR IS ACTIVATING CONSTANTLY. HAPPENED FIRST IN OT AND THEN RE-CREATED POST OP NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878141 ↗
• MalfunctionNov 18, 2024Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A THORACIC PROCEDURE THAT THE GENERATOR CAUSED A SMALL FIRE AND CHARRING. ANOTHER GENERATOR WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706659 ↗
• InjuryOct 15, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE CUSTOMER REPORTED A COMPLAINT. THE CUSTOMER ACCIDENTALLY PLUGGED IN A BI-POLAR INSTRUMENT INTO THE MONOPOLAR CONNECTION ON THE MEGEN1 B PORT. THE DEVICE AUTOMATICALLY ACTIVATED AND THERE WAS A PATIENT BURN ON THE NECK. CASE WAS ABLE TO BE COMPLETED BY PLUGGING IT INTO THE CORRECT PORT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20450443 ↗
• MalfunctionOct 15, 2024Self-Activation or Keying; Failure to Read Input Signal; Self-Activation or Keying; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MEGEN1 OPERATE THEM SELF AUTOMATICALLY WHEN ASSEMBLY THE RETURN ELECTRODE AND PENCIL IN PORT A. THERE WAS ALSO AN ERROR105-12 AFTER POWER THE GENERATOR MEGEN1 SN (B)(6). THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449771 ↗
• MalfunctionOct 14, 2024Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE UNIT IS "NOT GROUNDING THE PATIENT" AND "THROWING FLAMES" UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439179 ↗
• MalfunctionOct 1, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BIPOLAR MEGADYNE WORKING AUTOMATICALLY WITHOUT PRESSING A FOOTSWITCH. EVEN WHEN FOOTSWITCH WAS NOT PRESSED IT WAS WORKING AUTOMATICALLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343533 ↗
• MalfunctionAug 20, 2024Arcing of Electrodes; Activation, Positioning or Separation Problem; Arcing of Electrodes; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A UNKNOWN PROCEDURE, THEY HAD SPARKS AND FLAMES FROM THE TIP OF THE BOVIE WHILE ACTIVATING ENERGY. THE HANDPIECE BEING USED AT THE TIME OF INCIDENT WAS A VALLEY LAB BOVIE TIP. THE SURGERY TEAM OPTED TO CHANGE OUT THE TIP AND TRANSITION TO A MEGADYNE BOVIE TIP AND DECREASED THE SETTING FROM 40/40 TO 30/30. DOCTOR SAID THAT THE ISSUE WAS RESOLVED HOWEVER MENTIONED THE OUTPUT OF ENERGY WAS STILL HIGHER THAN SHE WOULD HAVE ANTICIPATED WITH THE SETTING BEING ON 30/30. IT WAS NOTED THAT THERE WERE NO ADVERSE PATIENT OUTCOME REPORTED. CASE WAS ABLE TO BE COMPLETED WHEN THEY TRANSFERRED TO THE MEGADYNE BOVIE TIP AND DECREASED THE SETTINGS. BIOMED DID RUN A FULL OUTPUT VERIFICATION AND FOUND NOTHING OUT OF THE ORDINARY WITH THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000759 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ICD PLACEMENT, THE TECH WAS STANDING NEXT TO THE SURGEON, BOVIE WAS INSIDE THE HOLSTER AND THERE WAS A METAL DEVICE HANGING FROM THE HOLSTER. THE FOOT PEDAL WAS ACTIVATED ACCIDENTALLY AND TECH WAS UNSURE IF HER ELBOW INTERACTED WITH THE METAL DEVICE BUT IT LEFT A BURN ON HER ELBOW. THE PENCIL WAS NOT TOUCHING THE PATIENT DURING THIS TIME. BOVIE SETTING WAS 50/50 CUT/COAG.

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

  MAUDE report 19604312 ↗