Megadyne 0035HRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10614559100493), received between Oct 30, 2017 and Nov 13, 2023 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2023Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN SEMINAL VESICLES PROCEDURE THE NEEDLE POINT TIP WITHIN THE PENCIL SPARKED A FIRE ON SCAR TISSUE ON FIRST ACTIVATION. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121301 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FEMORAL PROCEDURE THE DEVICE BURNED THE PATIENT ON THE INCISION SITE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17689881 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE POSTERIOR SPINAL FUSION PROCEDURE, THAT DURING A C2-T4 POSTERIOR CERVICAL FUSION, NERVE MONITORING NEEDLES WERE PLACED IN THE PATIENTS SHIN, CALF, AND FEET MUSCLES, AS WELL AS THE HANDS. AT THE COMPLETION OF THE PROCEDURE, PERCEIVED BURN MARKS WERE NOTED ON THE PATIENTS FEET AND LEGS AT THE NERVE MONITORING NEEDLE SITES. NO BURNS WERE NOTED AT THE HANDS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE PATIENT CONSEQUENCES.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 14853197 ↗
• MalfunctionMar 1, 2021Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BOVIE PENCIL TIP WAS SPARKED AND THE TIP WAS NOT AVAILABLE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392713 ↗
• MalfunctionAug 3, 2020Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD CUT BUT DID NOT ACTIVATE COAGULATION IN THE PRE-USE CHECK. IN ADDITION, EVEN WHEN THE BUTTON IS NOT PRESSED, THE CUT AND COAGULATION WERE SOMETIMES ACTIVATED. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10356125 ↗
• MalfunctionJul 23, 2020Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN ABDOMINOPERINEAL RESECTION WHILE WORKING ON THE DISSECTION OUT THE RECTUM, WHILE SITTING DOWN BELOW AT THE RECTUM, THE SURGEON NOTICED SMOKE NEAR A SPOT ON THE DRAPE WHERE THE DEVICE CORD WAS LAYING/DRAPED. A SMALL FIRE ERUPTED ON A TOWEL THAT WAS BETWEEN THE PATIENT¿S SKIN AND THE DRAPE, APPROXIMATELY SIX INCHES SUPERIOR TO THE USE OF A CAUTERY PENCIL. UPON INITIATION OF THE CAUTERY PENCIL, IN ABOUT 2-3 SECONDS AFTER, THE SURGEON NOTED THE SMELL OF SOMETHING BURNING. THE FLAME WAS NOTED TO BE ABOUT AN INCH HIGH AFTER THE DRAPE WAS PICKED UP AND IMMEDIATELY EXTINGUISHED. NO HARM TO THE PATIENT. THE FIRST PORTION OF AN ABDOMINAL/PERINEAL ROBOTIC CASE WAS COMPLETED AND THE PELVIC AREA RE-PREPPED. THE DRAPE IS THEN PLACED. POSSIBILITY PREP HAD LEAKED WITH GRAVITY TO THE TOWEL, PREP FUMES POSSIBLY IGNITING UPON CAUTERY IGNITION. THE SURGERY WAS DELAYED BY 15 MINUTES. THERE WERE NO FRAGMENTS GENERATED. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10315900 ↗
• MalfunctionJul 8, 2020Fire; Arcing of Electrodes; Fire; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A NEPHRECTOMY, THE ELECTRODE CAUGHT ON FIRE WHILE DISSECTING THROUGH TISSUE. THE GENERATOR WAS A MEGAPOWER 1000 SET ON CUT: 35 PURE, COAG: 35, COAG 1. THEY HAD JUST CUT THROUGH A MUSCLE LAYER AND WERE ABOVE THE TISSUE WHEN THE TIP PRODUCED A FLAME. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THEY OPENED A NEW PENCIL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10248445 ↗
• MalfunctionJul 8, 2020Fire; Arcing of Electrodes; Fire; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A NEPHRECTOMY, THE ELECTRODE CAUGHT ON FIRE WHILE DISSECTING THROUGH TISSUE. THE GENERATOR WAS A MEGAPOWER 1000 SET ON CUT: 35 PURE, COAG: 35, COAG 1. THEY HAD JUST CUT THROUGH A MUSCLE LAYER AND WERE ABOVE THE TISSUE WHEN THE TIP PRODUCED A FLAME. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THEY OPENED A NEW PENCIL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10248427 ↗
• MalfunctionJan 14, 2020Fire

  IT WAS REPORTED BY THE REP DURING AN EXPLORATORY LAPAROTOMY WITH THE SETTING ON 40.40 DURING THE OPENING OF THE MIDLINE INCISION, THE DEVICE WAS ARCHING AND FLAMES WERE SHOOTING OUT OF THE TIP. A SECOND DEVICE WAS TRIED, AND IT DID THE SAME THING. THE PATIENT HAD NO IMPLANTS OR TATTOOS. THE PROCEDURE WAS COMPLETED WITH A THIRD LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9589116 ↗
• MalfunctionJan 14, 2020Fire

  IT WAS REPORTED BY THE REP DURING AN EXPLORATORY LAPAROTOMY WITH THE SETTING ON 40.40 DURING THE OPENING OF THE MIDLINE INCISION, THE DEVICE WAS ARCHING AND FLAMES WERE SHOOTING OUT OF THE TIP. A SECOND DEVICE WAS TRIED, AND IT DID THE SAME THING. THE PATIENT HAD NO IMPLANTS OR TATTOOS. THE PROCEDURE WAS COMPLETED WITH A THIRD LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9589040 ↗
• MalfunctionNov 1, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS A FOREIGN MATTER IN THE PACKAGE. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269380 ↗
• MalfunctionAug 26, 2019Self-Activation or Keying

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE THE ELECTROSURGICAL PENCIL ACTIVATED WITHOUT THE BUTTONS BEING PRESSED. THE SURGICAL TEAM NOTED THAT THE PENCIL ACTIVATED WITH THE CORD WAS MANIPULATED MANUALLY WITHOUT DEPRESSING THE ACTIVATION BUTTONS. THE PENCILS WERE CONNECTED TO A (B)(6) GENERATOR. THE FIRST TWO PENCILS THEY UTILIZED IN THE CASE BOTH HAD THIS ISSUE. A THIRD PENCIL WAS OPENED AND DID NOT HAVE THIS ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8931980 ↗
• MalfunctionAug 26, 2019Self-Activation or Keying

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE THE ELECTROSURGICAL PENCIL ACTIVATED WITHOUT THE BUTTONS BEING PRESSED. THE SURGICAL TEAM NOTED THAT THE PENCIL ACTIVATED WITH THE CORD WAS MANIPULATED MANUALLY WITHOUT DEPRESSING THE ACTIVATION BUTTONS. THE PENCILS WERE CONNECTED TO A MEGAPOWER GENERATOR. THE FIRST TWO PENCILS THEY UTILIZED IN THE CASE BOTH HAD THIS ISSUE. A THIRD PENCIL WAS OPENED AND DID NOT HAVE THIS ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8931960 ↗
• MalfunctionJan 22, 2019Device Remains Activated

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SWITCH BUTTON DID NOT RETURN, AND THE DEVICE CONTINUED ACTIVATING WHEN THE DEVICE WAS USED FOR COAGULATION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266936 ↗
• MalfunctionOct 30, 2017Device Operates Differently Than Expected

  PLUGGED IN BOVIE AND IT ACTIVATED ON ITS OWN. UNPLUGGED IT, AND MADE SURE BUTTON WAS NOT BEING DEPRESSED AND PLUGGED IT BACK IN. IT ACTIVATED AGAIN BUT THE STAFF TOOK THE BOVIE OFF THE FIELD AND REPLACED WITH ANOTHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6986482 ↗