Megadyne 0037HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10614559101674), received between Apr 2, 2019 and Feb 22, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE CAUSING A BURN ON PATIENT LIP. GENERATOR USED IS MEGAPOWER MODEL 1000 SN(B)(6) AT SETTING 25 (COAG). PATIENT HAS VISIBLE BURN THAT MAY/MAY NOT REQUIRE SUBSEQUENT TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18760049 ↗
• MalfunctionSep 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE INSULATION OF THE ELECTRODE AT THE TIP OF THE SCALPEL CAME OFF. NO PIECES FELL INTO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17763723 ↗
• InjuryJul 24, 2023Self-Activation or Keying; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Self-Activation or Keying; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS ENERGIZED ON ITS OWN EVEN THOUGH NO ONE WAS TOUCHING IT, AND THE PATIENT SUFFERED BURNS BECAUSE IT WAS PLACED ON THE PATIENT'S LEG. ELECTRIC KNIFE HAD BUTTONS FACING UPWARDS. THERE WAS NO INDICATION THAT THE BUTTON WAS BEING PRESSED WHEN THE DEVICE WAS ENERGIZED ON ITS OWN. AFTER THE MALFUNCTION, THE DEVICE WAS FUNCTIONED WHEN PRESSING THE BUTTON. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s); Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 17378055 ↗
• MalfunctionFeb 8, 2023Self-Activation or Keying; Human-Device Interface Problem; Self-Activation or Keying; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE ENERGIZED WHEN THE TIP OF SCALPEL WAS LIGHTLY TOUCHED WHILE THE SWITCH WAS NOT PRESSED. THE PATIENT WAS BURNED WHEN THE SURGEON PLACED THE DEVICE ON THE DRAPE DUE TO THE ELECTRICAL CURRENT IN THE HOLSTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 16326485 ↗
• MalfunctionSep 16, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE KEPT CUTTING AND COAGULATING WHEN THE DEVICE WAS STARTED TO USE. THE DEVICE WAS SWITCHED OFF AND RESTARTED, BUT THE DEVICE KEPT COAGULATED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480526 ↗
• MalfunctionDec 13, 2019Fire

  IT WAS REPORTED THAT DURING A TONSILLECTOMY THE ¿BOVIE TIP IGNITED IN THE PATIENT¿S MOUTH". THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468383 ↗
• MalfunctionNov 1, 2019Contamination /Decontamination Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS A FOREIGN MATTER IN THE PACKAGE. IT WAS ALSO REPORTED THAT THE PACKAGE WAS DAMAGED. THE DEVICES WERE 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 9267270 ↗
• MalfunctionNov 1, 2019Break; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS A FOREIGN MATTER IN THE PACKAGE. IT WAS ALSO REPORTED THAT THE PACKAGE WAS DAMAGED. 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 9267198 ↗
• MalfunctionApr 2, 2019Fire

  IT WAS THAT DURING AN OPEN UNKNOWN PROCEDURE, THE TIP OF THE 0037H TOOK FIRE. 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 8475523 ↗