Mega Soft M2K01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559105177), received between Mar 31, 2022 and Mar 31, 2022 — classified as 1 malfunction.

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.

• MalfunctionMar 31, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED BY THAT WHILE THE SURGEON WAS PERFORMING A CABG WITH A MEGADOME ELECTRO SURGICAL AND MEGA SOFT ELECTRODE. THE ESS PENCIL TO THE DEBOKI SET A PIECE OF THE GAUZE ON FIRE. THE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13965103 ↗

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-1997-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Pediatric 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-1998-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal 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
• Z-2000-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery