Megadyne 0038HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10614559100844), received between Feb 22, 2021 and Jun 25, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE, THE DEVICE HAD BEEN TEMPORARILY STORED IN A NON-WOVEN POCKET AND SUDDENLY STARTED MOVING. THE DEVICE DID NOT STOP EVEN AFTER THE BUTTONS WERE PRESSED AGAIN, SO IT WAS REMOVED FROM THE MAIN BODY OF THE ELECTROCAUTERY SCALPEL AND ITS USE WAS STOPPED. 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 19604165 ↗
• MalfunctionOct 18, 2022Arcing of Electrodes; Arcing of Electrodes

  SEE ATTACHED MEDWATCH# 1721194-2022-00071.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624578 ↗
• MalfunctionOct 4, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AN INSECT WAS FOUND INSIDE THE PACKAGE. THE DEVICE WAS NOT USED FOR THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536935 ↗
• MalfunctionAug 18, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN APPENDECTOMY THE BOVIE ARCED NO STEPS WERE TAKEN TO ADJUST SETTINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15252329 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MASTECTOMY PROCEDURE A PATIENT WAS BURNED AT THE SURGICAL SITE WHILE THE MONOPLANE PENCIL WAS USED. THE CUSTOMER IS KEEPING THE PRODUCT UNTIL THE INCIDENT REPORT IS CLEAR. THEY HAVE ALSO HAD TO CONTACT THE ELECTROSURGICAL GENERATOR COMPANY, MEDTRONIC, TO SEE WHAT STEPS NEED TO BE TAKEN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11747206 ↗
• MalfunctionFeb 22, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN THE DEVICE ARRIVED, THE INNER BOX WAS OPENED. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357743 ↗