Mega Soft 0835Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10614559101872), received between Feb 23, 2023 and Feb 10, 2025 — classified as 3 injuries, 1 malfunction.

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

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

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. Jun 17, 2024Open, Classified

   To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

   Z-2250-2024 · Root cause: Unknown/Undetermined by firm · FDA record ↗

2. Jun 1, 2023Open, Classified

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

   Z-1996-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN WHILE USING AN ELECTROCAUTERY PENCIL, THE ELECTRICITY ARCED TO THE SURGEONS HAND HOLDING A LAPAROTOMY SPONGE. THE ARC CAUSED THE SPONGE TO LIGHT ON FIRE AND INITIALLY THE SURGEON THOUGHT HER GLOVE MAY HAVE HAD A HOLE BUT THERE WAS NO INDICATION OF A BURN OR INJURY TO HER FINGER. THE SURGEON BELIEVED THE MEGASOFT PAD TO BE THE CAUSE SO THEY CONTINUED THE CASE USING A STICKY PAD AND HAD NO FURTHER ISSUES. UPON INSPECTION, THE MEGASOFT PAD DID NOT APPEAR TO HAVE ANY DAMAGE, BURNS, OR OTHER ISSUES AND THE PATIENT DID NOT SUFFER ANY INJURIES EITHER. THE SURGERY WAS DELAYED 15 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. FIRE WAS PUT OUT AND A STICKY PAD WAS USED.,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343128 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THERE WAS A INJURY IN A PATIENT AFTER THE SURGERY, THE PATIENT SUFFERED FROM BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16712923 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ADENOTONSILLECTOMY OF A PEDIATRIC PATIENT THE PATIENT RECEIVED BURNS.

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

  MAUDE report 16429017 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ADENOTONSILLECTOMY OF A PEDIATRIC PATIENT THE PATIENT RECEIVED BURNS.

  Patient problems: Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 16428796 ↗