Mega Soft 0830Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10614559101797), received between Nov 2, 2020 and Oct 29, 2024 — classified as 7 injuries, 2 malfunctions.

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-2249-2024 · 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-1995-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HIP SURGERY THE PATIENT GOT BURN WHEN MEGASOFT WAS USED ON THE OPPOSITE SIDE OF THE PATIENT ( PART OF BODY TOUCHES THE TABLE NOT THE SURGICAL AREA). .

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20560236 ↗
• InjuryApr 29, 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 19205636 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock; Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DOCTOR WAS HOLDING THE BOVIE PENCIL IN HER HAND. DOCTOR FELT A SHOCK ON HER ABDOMEN. WE BELIEVE THE ELECTRICAL CURRENT JUMPED TO THE METAL ON HER BADGE. DOCTOR BROKE SCRUB. THERE WAS FOUND TO BE A BURN HOLE IN HER SURGICAL GOWN, AND IN HER SCRUB TOP, AND A BURN SITE ON HER ABDOMEN. AT THE TIME OF THE BOVIE BURN, WE WERE USING THE BOVIE GROUNDING PAD ON THE BED. THE BOVIE UNDERPAD WAS INTACT. AFTER THE BURN OCCURRED, A BOVIE PAD WAS PLACED ON THE RIGHT THIGH OF THE PATIENT, AND WE USED THIS GROUNDING PAD RATHER THAN THE UNDERPAD. FOLLOWED UP WITH DOCTOR AND SHE REPORTED THAT SHE WAS DOING WELL.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17260468 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17218710 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT WHILE ON A MEGASOFT PATIENT RETURN ELECTRODE PAD, THE PATIENT HAD A SMALL BURN IN A AREA WHERE IT WAS IDENTIFIED THAT THE PATIENT WAS TOUCHING THE METAL POSITIONING BAR. IT WAS ALSO REPORTED THAT ON VISUAL INSPECTION, THE PAD DID NOT HAVE ANY AREAS ON IT THAT MIGHT BE COMPROMISED.

  Patient problems: Discomfort; Partial thickness (Second Degree) Burn

  MAUDE report 16994934 ↗
• 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 16712972 ↗
• MalfunctionNov 21, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A SHEET WAS PLACED IN BETWEEN THE PATIENT AND THE MEGADYNE PAD. THE BROWN SPOTS ON THE SHEET SEEM TO BE BURN MARKS. THE PATIENT DID HAVE RED SPOTS ON HER SKIN WHERE THERE ARE BROWN MARKS WERE ON THE SHEET. THE PATIENT DID NOT GET BURNED AND THE MARKS DID GO AWAY ON HER SKIN. THE PADS HAVE BEEN REMOVED FROM THE OR AND ARE USING THE LEG STICKER PAD. THE PATIENT HAD SMALL RED MARKS ON THE SKIN WHICH DISAPPEARED AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834635 ↗
• MalfunctionJan 4, 2021Arcing of Electrodes; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Arcing of Electrodes; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE OUTPUT POWER OF THE ELECTRIC KNIFE WAS WEAK, AND INCREASED THE OUTPUT LEVEL. THEN THE CORD OF THE DEVICE GOT ON FIRE AND THE TIP OF THE RETURN ELECTRODE MELTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108426 ↗
• InjuryNov 2, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT A SMALL CHILD WAS BURNED. USER ERROR IS SUSPECTED AS THE SURGEON MAY HAVE ACCIDENTALLY COUPLED A KELLY CLAMP THAT WAS HOLDING A RED RUBBER CATHETER GOING THROUGH THE NOSE AND OUT OF THE MOUTH.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 10770510 ↗