Megadyne 0030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10614559100462), received between Feb 14, 2023 and Jun 12, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2024Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WITH THE APPROPRIATE PARAMETERS ALREADY MODIFIED (POWER IN THE GENERATOR), IT IS EVIDENT THAT IT GENERATES AN UNUSUAL FLAME IN THE SURGICAL FIELD, THE ELECTROCOAGULATION CONFIGURATION IS REDUCED TO AVOID BURNS. IN THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518399 ↗
• MalfunctionMar 12, 2024Arcing of Electrodes; Human-Device Interface Problem; Arcing of Electrodes; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A TENDON REPAIR THE ASEPSIS IS PERFORMED IN THE AREA TO BE OPERATED ON (WITH 4% CHLORHEXIDINE), PLACEMENT OF STERILE SURGICAL DRAPES, FIRST INCISION IS MADE WITH AN ELECTROSCALPEL TIP, ON CONTACT WITH THE SKIN IT PRESENTS A SPARK AND SLIGHT FLAME, A CHANGE OF DEVICE IS PERFORMED, THE AFFECTED AREA WAS CHECKED AND THE BURN OF THE EDGES OF THE SKIN WAS CORRECTED, WITH NO CONSEQUENCES FOR THE PATIENT, THERE WAS NO DELAY IN THE SURGERY. MEGAPOWER CONSOLE IS REMOVED FROM THE ROOM FOR PRIOR EVALUATION BY BIOMEDICS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

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

  MAUDE report 18884918 ↗
• InjuryFeb 14, 2023Arcing of Electrodes; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RESECTION OF SUBCUTANEOUS CELL TISSUE TUMOR IN THE POSTERIOR NECK THE PATIENT WAS IN THE FACE DOWN POSITION WITH OXYGEN CANNULA AND FACE MASK. THE PROCEDURE BEGAN AND THE ELECTIVE PENCIL GENERATED A SPARK, WHICH IS WHY ANOTHER PENCIL WAS REQUESTED, WHICH WHEN ACTIVATED GENERATED A FLAME OF FIRE ON THE PATIENT, CAUSING A BURN ON THE SKIN OF THE RIGHT CHEEKBONE OF THE PATIENT. THE FACE, BEHIND THE EAR AND THE HAIR. THE PERSONNEL CONTROL THE FIRE AND FINISH THE PROCEDURE WITH ANOTHER MEDTRONIC ELECTRO PENCIL AND THE VALLEYLAB CONSOLE. THE SURGERY WAS DELAYED 20 MINUTES. THE FLAMES WERE EXTINGUISHED, THE PATIENT WAS CLEANED AND THE PROCEDURE WAS FINISHED WITH A VALLEYLAB CONSOLE AND AN ELECTRO PEN FROM MEDTRONIC.

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

  MAUDE report 16375372 ↗
• InjuryFeb 14, 2023Arcing of Electrodes; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RESECTION OF SUBCUTANEOUS CELL TISSUE TUMOR IN THE POSTERIOR NECK THE PATIENT WAS IN THE FACE DOWN POSITION WITH OXYGEN CANNULA AND FACE MASK. THE PROCEDURE BEGAN AND THE ELECTIVE PENCIL GENERATED A SPARK, WHICH IS WHY ANOTHER PENCIL WAS REQUESTED, WHICH WHEN ACTIVATED GENERATED A FLAME OF FIRE ON THE PATIENT, CAUSING A BURN ON THE SKIN OF THE RIGHT CHEEKBONE OF THE PATIENT. THE FACE, BEHIND THE EAR AND THE HAIR. THE PERSONNEL CONTROL THE FIRE AND FINISH THE PROCEDURE WITH ANOTHER MEDTRONIC ELECTRO PENCIL AND THE VALLEYLAB CONSOLE. THE SURGERY WAS DELAYED 20 MINUTES. THE FLAMES WERE EXTINGUISHED, THE PATIENT WAS CLEANED AND THE PROCEDURE WAS FINISHED WITH A VALLEYLAB CONSOLE AND AN ELECTRO PEN FROM MEDTRONIC.

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

  MAUDE report 16375193 ↗