MEGADYNE MESE1Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10614559104545), received between Oct 1, 2020 and Aug 7, 2026 — classified as 2 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (60 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Difficult or Delayed Activation; Ventilation Problem in Device Environment

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175117 ↗
• MalfunctionJun 23, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT SINCE (B)(6) 2025 THE DEVICE CONTINUOUSLY RUNS WHILE IN OPEN MODE, WHEN CONNECTED VIA DIRECT CONNECT TO FT10 GENERATOR. TO LESSON THE SOUND THEY PUT THE UNIT IN LAP MODE. TO KEEP THE UNIT FROM PULLING AIR ALL THE TIME THEY LEAVE THE RED CAP ON THE FLUID TRAP TO SAVE THE LIFE OF THEIR FILTER. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306514 ↗
• 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 21528882 ↗
• 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 21528701 ↗
• 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 21528635 ↗
• MalfunctionJan 22, 2025Difficult or Delayed Activation; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Difficult or Delayed Activation; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A NEW MESE1 EVACUATOR UNIT WAS MAKING LOUD NOISES AND RANDOM CLICKING SOUNDS. ALSO PULLING AIR WHEN PENCIL WAS NOT BEING ACTIVATED IN OPEN MODE USING THE CONNECT CABLE ATTACHED TO THE FT10 MEDTRONIC ESU. UNIT USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207323 ↗
• MalfunctionJan 21, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE SMOKE EVACUATOR IS ON AND NO ONE IS IN THE ROOM. NOTHING IS ATTACHED TO THE SMOKE EVACUATOR AND AS IT IS SO QUIET THE UNIT CONTINUES TO RUN AND NO ONE NOTICES. THIS IS CAUSING FILTER LIFE TO END PREMATURELY. EVERY TIME THEY UNPLUG FROM THE WALL OUR UNIT IS A FLIP SWITCH AND THEY ARE USE TO A PUSH BUTTON. IF THE SMOKE EVACUATOR IS TURNED ON FIRST AND THEN TURN ON THE BOVIE, THEN IT JUST RUNS. SOME OF THE NURSES DON'T HEAR IT RUNNING, AND THEY COULD RUN A UNIT FOR FOUR HOURS NOT KNOWING IT'S ON. ON JUST THAT BOVIE IT HAS TO GET A BASE LINE WHEN THE CABLE IS ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196677 ↗
• MalfunctionJan 21, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE SMOKE EVACUATOR IS ON AND NO ONE IS IN THE ROOM. NOTHING IS ATTACHED TO THE SMOKE EVACUATOR AND AS IT IS SO QUIET THE UNIT CONTINUES TO RUN AND NO ONE NOTICES. THIS IS CAUSING FILTER LIFE TO END PREMATURELY. EVERY TIME THEY UNPLUG FROM THE WALL OUR UNIT IS A FLIP SWITCH AND THEY ARE USE TO A PUSH BUTTON. IF THE SMOKE EVACUATOR IS TURNED ON FIRST AND THEN TURN ON THE BOVIE, THEN IT JUST RUNS. SOME OF THE NURSES DON'T HEAR IT RUNNING, AND THEY COULD RUN A UNIT FOR FOUR HOURS NOT KNOWING IT'S ON. ON JUST THAT BOVIE IT HAS TO GET A BASE LINE WHEN THE CABLE IS ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196676 ↗
• MalfunctionJan 21, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE SMOKE EVACUATOR IS ON AND NO ONE IS IN THE ROOM. NOTHING IS ATTACHED TO THE SMOKE EVACUATOR AND AS IT IS SO QUIET THE UNIT CONTINUES TO RUN AND NO ONE NOTICES. THIS IS CAUSING FILTER LIFE TO END PREMATURELY. EVERY TIME THEY UNPLUG FROM THE WALL OUR UNIT IS A FLIP SWITCH AND THEY ARE USE TO A PUSH BUTTON. IF THE SMOKE EVACUATOR IS TURNED ON FIRST AND THEN TURN ON THE BOVIE, THEN IT JUST RUNS. SOME OF THE NURSES DON'T HEAR IT RUNNING, AND THEY COULD RUN A UNIT FOR FOUR HOURS NOT KNOWING IT'S ON. ON JUST THAT BOVIE IT HAS TO GET A BASE LINE WHEN THE CABLE IS ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196671 ↗
• MalfunctionJan 21, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE SMOKE EVACUATOR IS ON AND NO ONE IS IN THE ROOM. NOTHING IS ATTACHED TO THE SMOKE EVACUATOR AND AS IT IS SO QUIET THE UNIT CONTINUES TO RUN AND NO ONE NOTICES. THIS IS CAUSING FILTER LIFE TO END PREMATURELY. EVERY TIME THEY UNPLUG FROM THE WALL OUR UNIT IS A FLIP SWITCH AND THEY ARE USE TO A PUSH BUTTON. IF THE SMOKE EVACUATOR IS TURNED ON FIRST AND THEN TURN ON THE BOVIE, THEN IT JUST RUNS. SOME OF THE NURSES DON'T HEAR IT RUNNING, AND THEY COULD RUN A UNIT FOR FOUR HOURS NOT KNOWING IT'S ON. ON JUST THAT BOVIE IT HAS TO GET A BASE LINE WHEN THE CABLE IS ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196667 ↗
• MalfunctionJan 21, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE SMOKE EVACUATOR IS ON AND NO ONE IS IN THE ROOM. NOTHING IS ATTACHED TO THE SMOKE EVACUATOR AND AS IT IS SO QUIET THE UNIT CONTINUES TO RUN AND NO ONE NOTICES. THIS IS CAUSING FILTER LIFE TO END PREMATURELY. EVERY TIME THEY UNPLUG FROM THE WALL OUR UNIT IS A FLIP SWITCH AND THEY ARE USE TO A PUSH BUTTON. IF THE SMOKE EVACUATOR IS TURNED ON FIRST AND THEN TURN ON THE BOVIE, THEN IT JUST RUNS. SOME OF THE NURSES DON'T HEAR IT RUNNING, AND THEY COULD RUN A UNIT FOR FOUR HOURS NOT KNOWING IT'S ON. ON JUST THAT BOVIE IT HAS TO GET A BASE LINE WHEN THE CABLE IS ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196562 ↗
• MalfunctionDec 9, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A CANCER SURGERY, WHEN YOU START USING THE EVACUATOR, SOMETIMES IT STAYS ON CONTINUOUSLY, AND IN CUT-OFF MODE THE EVACUATION DOES NOT WORK. THE SURGERY ENDED WITH THE SAME PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20877532 ↗
• MalfunctionOct 22, 2024Difficult or Delayed Activation; Noise, Audible; Difficult or Delayed Activation; Noise, Audible

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A RATTLING SOUND LIKE A METALLIC SOUND MAY SOUND WHEN FLUSHING. WHEN USED IN CONJUNCTION WITH OTHER COMPANIES' ELECTROSURGERY UNITS, SMOKE MAY REMAIN FLUE ALL THE TIME. TURNING THE POWER ON AND OFF DOES NOT FIX IT. IT IS THE SAME FOR CONNECTING CABLES, 2403J AND RF SENSORS AS OTHER ELECTROSURGICAL EQUIPMENT. IT REMAINS IN SMOKE EXHAUST ALL THE TIME, ESPECIALLY WHEN IT IS OPEN. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504197 ↗
• MalfunctionSep 10, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT AT THE 90 DAY EVALUATION THE RF SENSOR SELF ACTIVATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179603 ↗
• MalfunctionMay 22, 2024Difficult or Delayed Activation; Noise, Audible; Difficult or Delayed Activation; Noise, Audible

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE IS VERY NOISY WHEN IN USE AND SUCKING AIR IN EVEN WHEN NOT ATTACHED TO DIATHERMY MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370535 ↗
• MalfunctionApr 4, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SMOKE FLUE DOES NOT STOP OR THE SMOKE FLUE SWITCH DOES NOT TURN ON. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042820 ↗
• MalfunctionJan 11, 2024Difficult or Delayed Activation; Noise, Audible; Difficult or Delayed Activation; Noise, Audible

  IT WAS REPORTED THAT DURING THE COMPREHENSIVE INSPECTION WE CONNECTED IT TO MEGA POWER1000 AND CONFIRMED THAT IT DID NOT STOP AFTER IT WAS CONNECTED. WE HAVE CONFIRMED THAT THE PUMP IS MAKING AN ABNORMAL NOISE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE CUSTOMER DOES NOT WANT TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18492131 ↗
• MalfunctionOct 5, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MESE1 WAS MALFUNCTION. WHEN I POWER ON THE UNIT WITHOUT RF SENSOR AND TRY TO TEST THE FUNCTIONAL BY PRESSED THE MANUAL BUTTON MESE1 WAS FUNCTION NORMALLY. BUT IF I POWER ON THE UNIT WITH RF SENSOR TOGETHER WITH MEGEN1 AND TELESCOPING SMOKE EVACUATION SOFT TISSUE DISSECTOR; I TRY TO PRESSED THE DISSECTOR BY HANDSWITCH MESE1 DOESN?T FUNCTION. IF I POWER ON THE UNIT AND CONNECT RF SENSOR AT THE BACK OF THE MESE1 THE MESE1 WILL FUNCTION AUTOMATICALLY WITHOUT PRESSING THE DISSECTOR. SERIAL NUMBER : (B)(6). THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875860 ↗
• MalfunctionAug 14, 2023Difficult or Delayed Activation; Noise, Audible; Difficult or Delayed Activation; Noise, Audible

  IT WAS REPORTED THAT THE UNIT IS EXCESSIVELY LOUD AND WILL NOT POWER OFF DURING ACTIVATION OF BOVIE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542685 ↗
• MalfunctionAug 14, 2023Difficult or Delayed Activation; Ventilation Problem in Device Environment; Appropriate Device Problem Term/Code Not Available; Difficult or Delayed Activation; Ventilation Problem in Device Environment; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A TESTING THE SHORT PLUG WAS NOT RECOGNIZED. THE MESE1 IS ACTING AS DESIGNED AND THE DEVICE DOES NOT NEED TO BE RETURNED FOR SERVICE. WE SET THE GENERATORS CURRENT SENSOR SENSITIVITY UP AND THAT WORKED. THE ACTIVATION SEEMED NORMAL. BUT THEN IT SEEMED A BIT SLOW WITH THE CUT BUTTON. THEY TURNED IT UP A NOTCH, IT KEPT ON GOING. THEY TURNED IT DOWN, IT KEPT ON GOING. THEY PUT IT BACK TO SETTING 3, AS WE STARTED OUT, AND IT WORKED LIKE A CHARM. THEN, THE MACHINE STARTED TO TURN ON RANDOMLY. SO THE PENCIL WAY PLUGGED IN, BUT LAYING DOWN ON THE TABLE, NO ACTIVATIONS WERE DONE, BUT DESPITE, THE MESE1 WAS ACTIVATED MULTIPLE TIMES.¿ ¿THEY ALSO HAD A PLUG/WORK AROUND INSTEAD OF A MEGASOFT/RETURN ELEKTRO.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542111 ↗
• MalfunctionFeb 14, 2023Difficult or Delayed Activation; Noise, Audible; Difficult or Delayed Activation; Noise, Audible

  IT WAS REPORTED THE DURING AN UNKNOWN PROCEDURE THERE ARE STRANGE "TIK TAK" SOUNDS HEARD ESPECIALLY IN LAP MODE (LV1-5). THE SMOKE EVACUATOR WOULD ACTIVATE AUTOMATICALLY EVEN THOUGH THE ENERGY CAPITAL/ DIATHERMY HAS NOT ACTIVATED AND THE SMOKE EVACUATOR WOULD NOT STOP AFTER RUN TIME HAS REACHED/ MANUAL STOP BUTTON IS PRESSED. IT IS NOISY WHEN OPERATING IN OPEN MODE (LV3-5).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371862 ↗
• MalfunctionFeb 2, 2023Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Ventilation Problem in Device Environment; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Ventilation Problem in Device Environment

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE FLOW RATE IS OUT OF SPEC. THE UNIT WAS TOO SENSITIVE SO WHEN THE AUTOACTIVATION FUNCTION CAME ON WHEN IT IS NOT SUPPOSED TO, AND DEFLATED THE PNEUMOPERITONEUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283528 ↗
• InjuryFeb 2, 2023Arcing at Paddles; Adverse Event Without Identified Device or Use Problem; Arcing at Paddles; 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 16283070 ↗
• MalfunctionJan 6, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS TRIGGERING CONSTANTLY. THE CHANGED RF AND CONNECT CABLES BUT THE SAME ISSUES CONTINUED THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112302 ↗
• MalfunctionNov 29, 2022Difficult or Delayed Activation; Noise, Audible; Difficult or Delayed Activation; Noise, Audible

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE POWER SWITCH OF THE MEGADYNE SMOKE EVACUATOR WAS OUT OF ORDER. THE SMOKE EVACUATOR REMAINS ON/ ACTIVATED AFTER USING THE POWER SWITCH TO TURN OFF THE MACHINE. NURSE ALSO COMPLAINED THAT THE OPERATIONAL NOISE LEVEL FOR THIS MACHINE IS HIGHER THAN WHEN THEY FIRST USED IT AND THE NOISE LEVEL DISTRACTED DOCTOR¿S FOCUS ON THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877420 ↗