Megadyne 1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10614559103715), received between Aug 24, 2017 and Jun 17, 2026 — classified as 12 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (31 reports).

1 other recall cover devices cleared under the same FDA submission (K050579); 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 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Arcing of Electrodes

  IT WAS REPORTED THAT, UPON STARTING AN UNKNOWN PROCEDURE, THE SURGEON USED THE CUT TO MAKE THE INCISION. THE PT'S HAIR SINGED AND A FIRE WAS VISIBLE ON THE SKIN. THE FLAME WAS QUICKLY EXTINGUISHED AND PATIENT WAS FINE. WE BELIEVE IT WAS DUE TO THE PREP NOT BEING LEFT TO DRY, HOWEVER, WE WOULD LIKE IT CHECKED TO RULE EVERYTHING ELSE OUT. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534727 ↗
• MalfunctionMar 26, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT THE OR STAFF STATED THE UNIT CONTINUES TO ACTIVATE EVEN AFTER ACTIVATION IS STOPPED DURING AN UNKNOWN PROCEDURE. THE OR STAFF ALSO REPORTED THAT THE UNIT IS INTERFERING WITH THE MONITOR. NO OTHER INFORMATION WAS AVAILABLE. THE CUSTOMER WAS UNABLE TO DUPLICATE THE ISSUE DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705657 ↗
• MalfunctionFeb 25, 2026Difficult or Delayed Activation; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE OR STAFF REPORTED THAT DURING AN UNKNOWN PROCEDURE THE GENERATOR MAKES THE ENDO-CAMERA DISPLAY FLICKER AND ONCE THEY STOPPED USING THE FOOTSWITCH THE UNIT WAS STILL CAUTERIZING. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441902 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE, WHEN THEY WENT TO REMOVE THE THEY NOTICED THAT THERE WAS BURN ON THE PATIENT NEAR THE ELECTRO PAD.

  Patient problems: Burn(s)

  MAUDE report 23585524 ↗
• MalfunctionAug 12, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHERE THE SURGEON FELT AN ELECTRIC CURRENT GOING THROUGH THE INSTRUMENT. THE INSTRUMENT WAS HANDED TO THE PA, WHO ALSO EXPERIENCED THE SENSATION. THEY SET THE INSTRUMENT DOWN, AND IT SUBSEQUENTLY SET A WET SPONGE ON FIRE. NO PATIENT OR USER CONSEQUENCES WERE REPORTED. THE GENERATOR WAS SENT TO BIOMED FOR TROUBLESHOOTING. BIOMED STATED THAT THE DEPARTMENT DISPOSED OF THE GROUNDING PAD BUT KEPT THE INSTRUMENT. THEY ARE UNSURE OF THE EXACT INSTRUMENT TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782578 ↗
• MalfunctionJun 4, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE EQUIPMENT IS TURNING ON BY ITSELF WITHOUT STEPPING ON THE PEDAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140174 ↗
• MalfunctionMay 20, 2025Fire; Fire

  IT WAS REPORTED THAT DURING AN OPEN GYN CASE, WHILE USING THE MEGAPOWER, A COMPETITOR'S CORD PLUGGED INTO THE MEGAPOWER GENERATOR CAUGHT FIRE. THE HANDPIECE WAS A SUCTION COAGULATOR. THEY SAID THAT THE DOCTORS NOTICED THE CORD WAS STARTING TO GET WARM. THEY THOUGHT IT WAS THE HANDPIECE. THEY PUT A NEW HANDPIECE ON. THE CORD SPARKED AND WAS A LITTLE BIT ON FIRE. THE FIRE WENT OUT, NO HARM TO PATIENT OR PEOPLE IN THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051308 ↗
• MalfunctionMay 9, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS AN ISSUE WHERE A MONOPOLAR CORD CAUGHT ON FIRE DURING A PROCEDURE. THE CUSTOMER REPORTED THE FIRE STARTED WHERE THE MONOPOLAR CORD CONNECTS TO THE MONOPOLAR ADAPTER. THE SALES REP REPORTED THAT THE ADAPTER AND CORD ARE NOT OUR PRODUCTS. CUSTOMER WANTS TO KNOW IF THE MEGAPOWER 1000 IS SAFE TO USE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992826 ↗
• MalfunctionMay 9, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS AN ISSUE WHERE A MONOPOLAR CORD CAUGHT ON FIRE DURING A PROCEDURE. THE CUSTOMER REPORTED THE FIRE STARTED WHERE THE MONOPOLAR CORD CONNECTS TO THE MONOPOLAR ADAPTER. THE SALES REP REPORTED THAT THE ADAPTER AND CORD ARE NOT OUR PRODUCTS. CUSTOMER WANTS TO KNOW IF THE MEGAPOWER 1000 IS SAFE TO USE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992782 ↗
• MalfunctionMay 8, 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 WHEN THE SURGEON STOPPED ACTIVATING, THEY COULD STILL HEAR THE ACTIVATION TONE. BIOMED WAS UNABLE TO DUPLICATE BUT DID RECEIVE ERROR 219. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984888 ↗
• MalfunctionJan 29, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BIPOLAR STAYS ACTIVATED. CASE COMPLETED WITH ANOTHER UNIT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263029 ↗
• MalfunctionJan 24, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A RADICAL CYSTECTOMY PROCEDURE THAT THE BOVIE TIP CAUGHT ON FIRE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228514 ↗
• MalfunctionOct 29, 2024Arcing of Electrodes; Arcing of Electrodes

  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 20560254 ↗
• MalfunctionFeb 16, 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 OR STAFF STATED THE THE THE UNIT IS ACTIVATING ON IT'S OWN. CUSTOMER STATED THAT WHILE TESTING COAG, THE SYSTEM GOES INTO AN ALARM. CUSTOMER STATED NO ERROR CODES PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720948 ↗
• MalfunctionOct 23, 2023Fire; Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THERE WAS A SPARK AND IT IGNITED THE O2 MASK DURING A PROCEDURE. UNKNOWN IF PATIENT INJURY. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985052 ↗
• MalfunctionSep 25, 2023Arcing of Electrodes; Material Integrity Problem; Arcing of Electrodes; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT A NON-OEM REUSABLE FOOT CONTROL CORD CAUGHT FIRE WHILE BEING USED WITH THE 1000 GENERATOR DURING A PROCEDURE. A SECOND GENERATOR WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCES FOR THE PATIENT. CUSTOMER ALSO REPORTED DAMAGED FACEPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806794 ↗
• MalfunctionSep 21, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE GENERATOR WILL STAY ACTIVATED WHEN BI-POLAR IS ACTIVATED. THEY SAY THIS HAS HAPPENED MULTIPLE TIMES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17790327 ↗
• MalfunctionSep 21, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE UNIT WOULD NOT STOP ACTIVATING WITH FOOT ACTIVATION. ANOTHER GENERATOR WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17790252 ↗
• MalfunctionSep 19, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ACTIVATION CONTINUES AFTER FOOTSWITCH IS RELEASED IN PURE CUT MODE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774459 ↗
• MalfunctionJul 24, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BIPOLAR IS ACTIVATING ON ITS OWN WITHOUT PRESSING ON THE FOOT PEDAL. THEY COULD NOT GIVE ME THE EXACT PRODUCT CODE EXCEPT THAT IT IS THE BI-POLAR FORCEPS WITH DISPOSABLE CORD. THEY SAY IT IS FOOT PEDAL ACTIVATED ONLY. THEY TRIED SWAPPING THE CABLE AND INSTRUMENT WITH NO SUCCESS THE BIOMED WAS TO DO A POWER OUTPUT TEST AND CHECK THE FOOT PEDAL FOR DAMAGE AND/OR FUNCTIONALITY. THEY WILL TRY TO FIND OUT WHAT PRODUCT CODE THEY ARE USING. IF THE GENERATOR IS BAD IT IS NO LONGER SUPPORTED AND THEY SHOULD REPLACE THE GENERATOR. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378474 ↗
• InjuryJul 18, 2023Arcing of Electrodes; Human-Device Interface Problem; Arcing of Electrodes; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND BEFORE THE INCISION; COMBUSTION OCCURS WITH SUBSEQUENT FIRE, WHERE THEY REFER TO DISPOSABLE SURGICAL FIELDS BEING BURNED, UPON EVALUATION OF THE PATIENT, LESIONS ARE EVIDENCED IN THE LATERAL REGION OF THE HIP AND RIGHT THIGH, LOSS OF HAIR IS EVIDENCED ON THE LOWER LIMBS, SCROTUM, AND CROTCH SECONDARY TO THE BURN , REDNESS IS OBSERVED IN THE ABDOMINAL REGION, THE POSITION OF THE PLATE IN THE RIGHT SHOULDER BLADE IS VERIFIED, WHICH IS CONNECTED TO THE CONSOLE, THE PLASTIC SURGEON IS NOTIFIED FOR EVALUATION AND THE SURGICAL PROCEDURE IS DEFERRED IT IS IMPORTANT TO HIGHLIGHT THAT THE INFORMATION RECEIVED BY THE WARD MANAGER IS THAT THE MEGADYNE GENERATOR WAS USED IN COMBINATION WITH MEDTRONIC RETURN ELECTRODE TECHNOLOGY.

  Patient problems: Burn(s)

  MAUDE report 17341588 ↗
• MalfunctionJul 17, 2023Self-Activation or Keying; Human-Device Interface Problem; Self-Activation or Keying; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY + LAPAROSCOPIC SALPINGECTOMY + LAPAROSCOPIC PELVIC ADHESIOLYSIS THE SURGEON USED THE HIGH-FREQUENCY ELECTROTOME TO REMOVE THE FALLOPIAN TUBE, THE NURSE HELD THE ELECTROTOME. THE DEVICE DID NOT START , BUT IT WAS ACTIVATED UNEXPECTEDLY, CAUSING THE NURSE'S HAND TO BE SLIGHTLY BURNED. ANOTHER DEVICE WAS USED TO CONTINUE THE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334445 ↗
• MalfunctionJun 7, 2023Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT A MEGA POWER THAT CAUSED AN INCIDENT WHILE IN USE. THE BOVIE TIP CAUGHT FIRE DURING USE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078145 ↗
• MalfunctionMay 23, 2023Self-Activation or Keying; Failure to Read Input Signal; Activation, Positioning or Separation Problem; Self-Activation or Keying; Failure to Read Input Signal; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE UNIT WAS CUTTING IN AND OUT ON THE BIPOLAR THEN AFTER TESTING IT, IT WAS FOUND OUT THAT IS WAS STILL DOING IT AND THAT IT WAS SHOOTING WAY OVER THE POWER LIMITS. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983200 ↗
• MalfunctionMay 23, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE UNIT IS STILL ACTIVATING ON CUT OR COAG WITHOUT FOOT PEDDLE, FOOT PEDDLES HAVE BEEN CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983106 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050579. One submission often covers many models, so check the product and lot details in each record.

• Z-2792-2018 · May 15, 2018 · Terminated
  MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715