Mega Soft M2K07Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10614559105238), received between Feb 10, 2020 and Dec 12, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2022Fire; Material Integrity Problem; Fire; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN AMBILOCAL HERNIA REPAIR PROCEDURE, THE CABLE BROKE AND THEN BURNED. IT BURNT THE DRAW SHEET AND HOVER PAD. IT DID NOT BURN THE PATIENT. THIS WAS DISCOVERED AT THE END OF THE CASE WHEN IT WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958165 ↗
• MalfunctionNov 1, 2022Arcing of Electrodes; Material Integrity Problem; Arcing of Electrodes; Material Integrity Problem

  IT WAS REPORTED THAT DURING A C-SECTION SURGERY, THE SOUND OF AN EXPLOSION FROM THE CABLE M2K07 WAS HEARD, THE CABLE RAISED SMOKE AND WAS CUT. THE SURGERY WAS DELAYED 10 MINUTES. THEY REPLACED THE MEGASOFT PAD TO A STICKY PAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708195 ↗
• MalfunctionOct 18, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING THE HEMORRHOIDECTOMY PROCEDURE, THEY NOTICED THAT THE CORD WAS BURNING. IT BURNT THE SHEET A LITTLE, BUT THE PATIENT WAS NOT BURNED OR INVOLVED. NO ALARMS WENT OFF ON THE GENERATOR. UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624030 ↗
• MalfunctionSep 19, 2022Arcing of Electrodes; Material Integrity Problem; Arcing of Electrodes; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CABLE SUDDENLY SELF-IGNITED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445529 ↗
• MalfunctionFeb 13, 2020Material Frayed; Scratched Material

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PIGTAIL CORD WHERE THE DEVICE ATTACHES TO THE MEGASOFT PAD WAS FRAYED AND HAD EXPOSED WIRES. NO PATIENT INVOLVEMENT OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707934 ↗
• MalfunctionFeb 11, 2020Scratched Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A SPLIT IN THE CORD WHERE IT CONNECTS TO THE MEGASOFT PAD AND THE WIRES WERE EXPOSED. NO PATIENT INVOLVEMENT OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 9696222 ↗
• MalfunctionFeb 10, 2020Scratched Material

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CORD OF THE DEVICE HAD THE PROTECTIVE COATING PEELED OFF IN ONE AREA AND THE WIRES WERE EXPOSED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687742 ↗

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