Mega Soft M2K02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559105184), received between Feb 14, 2023 and Feb 14, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Arcing of Electrodes” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K080741, K133726); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 16375233 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080741, K133726. One submission often covers many models, so check the product and lot details in each record.

• Z-2248-2024 · Jun 17, 2024 · Open, Classified
  Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Descr
• Z-1920-2024 · May 8, 2024 · Open, Classified
  MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electr
• Z-0597-2024 · Dec 8, 2023 · Open, Classified
  Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
• Z-2000-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
• Z-1998-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
• Z-1999-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
• Z-1997-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
• Z-2001-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery