MEGADYNE 251015JRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10614559105580), received between Nov 8, 2021 and May 1, 2025 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionMay 1, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHILE STOCKING SHELVES IT WAS FOUND THAT THE DEVICE HAS A DAMAGED STERILE BLISTER PACKAGE. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941482 ↗
• MalfunctionNov 21, 2022Flaked; Appropriate Device Problem Term/Code Not Available; Flaked; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAP BAND REMOVAL DUE TO GASTRIC NECROSIS PROCEDURE WHILE ACTIVATING THE PENCIL MADE A ¿POP¿ SOUND AND THEN A FLASH OF FLAME WAS SEEN THAT EXTINGUISHED ON ITS OWN WITH NO HARM TO THE PATIENT. THE STICKY PAD WAS THEN REMOVED AND REPLACED, AND SURGEON THEN SWITCHED TO HARMONIC TO CONTINUE WITH A PORTION OF THE CASE. SURGEON THEN LATER WENT BACK TO USING THE BOVIE WITH NOT FURTHER ISSUE. THERE WERE NO ERROR CODES REPORTED ON THE GENERATOR. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834199 ↗
• MalfunctionNov 21, 2022Flaked; Appropriate Device Problem Term/Code Not Available; Flaked; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAP BAND REMOVAL DUE TO GASTRIC NECROSIS PROCEDURE THAT WHILE ACTIVATING THE BOVIE PENCIL THE PENCIL MADE A ¿POP¿ SOUND THEN THERE WAS A FLAME WHICH IGNITED THE SPONGE THAT WAS NEARBY. FIRE WAS EXTINGUISHED WITH NO HARM TO THE PATIENT. THE STICKY PAD WAS THEN REMOVED AND REPLACED, AND SURGEON THEN SWITCHED TO HARMONIC TO CONTINUE WITH A PORTION OF THE CASE. SURGEON THEN LATER WENT BACK TO USING THE BOVIE WITH NO FURTHER ISSUE. THERE WERE NO ERROR CODES REPORTED ON THE GENERATOR. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834124 ↗
• InjuryNov 8, 2021Flaked; Difficult or Delayed Activation; Appropriate Device Problem Term/Code Not Available; Flaked; Difficult or Delayed Activation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BOVI ARCED, CAUGHT THE DRAPE ON FIRE, AND THE PATIENT SUFFERED A SEVERE BURN. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 12770991 ↗