Mega Soft 0840Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10614559103395), received between May 12, 2021 and Jul 9, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K080741); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 8, 2024Open, Classified

   Reports of patient burns.

   Z-1920-2024 · Root cause: Device Design · FDA record ↗

2. Jun 1, 2023Open, Classified

   Firm has received reports of patient burns in surgical procedures where device was used.

   Z-1997-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Human-Device Interface Problem; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Human-Device Interface Problem; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PEDIATRIC SURGERY, IT WAS FOUND THAT THERE WAS REDNESS IN PART OF THE DEVICE AFTER THE SURGERY. DR. CONCERNED THAT THERE MIGHT HAVE BEEN AFFECTED. IT IS NOT CLEAR THAT IF THIS HAPPENED WITH THE PRODUCT CURRENTLY IN THE HOSPITAL, BUT IT WAS DECIDED THAT THE DEVICE WILL NOT BE USED IN THE FUTURE. THE PRODUCTS CURRENTLY IN THE HOSPITAL ARE OUTSIDE THE EXPIRATION DATE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADDITIONAL TREATMENT ON THE PATIENT. THE PATIENT IS STABLE. IT IS DIFFICULT TO OBTAIN ANY FURTHER ADDITIONAL INFORMATION, SUCH AS THE CONDITIONS OF THE DEVICE WHEN IT WAS USED.

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

  MAUDE report 19700181 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN APPENDECTOMY THE PATIENT'S BUTTOCKS WERE BURNED AFTER THE OPERATION WAS COMPLETED

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 19137801 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP ONE DAY OF A RIGHT EXTENDED HEPATECTOMY, THE PATIENT HAS DEVELOPED BURN MARKS ON THE BUTTOCKS AREA , THE SURGEON HAS RAISED AN COMPLAINT FOR CAUTERY PAD BURNS.

  Patient problems: Blister; Necrosis; Partial thickness (Second Degree) Burn

  MAUDE report 11844127 ↗
• MalfunctionMay 13, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A ABDOMINOPERINEAL RESECTION, THERE WAS NO SKIN DAMAGE DETECTED IMMEDIATELY POST OPERATIVELY, IT APPEARED THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819912 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LOWER ANTERIOR RESECTION, A BURN WAS DISCOVERED ON THE PATIENT POST OPERATION. ELECTROSURGERY BURN ON BACK OF PATIENT. NO DELAY TO SURGERY.

  Patient problems: Pain; Partial thickness (Second Degree) Burn; Swelling/ Edema

  MAUDE report 11812202 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080741. 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