Mega Soft 0847Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10614559104842), received between Sep 13, 2021 and Mar 30, 2026 — classified as 7 injuries, 3 malfunctions.

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

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

4 other recalls cover devices cleared under the same FDA submission (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 8, 2023Open, Classified

   Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

   Z-0599-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Jun 1, 2023Open, Classified

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

   Z-1999-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY WERE PERFORMING A PACEMAKER SURGERY ON A PATIENT WHEN A FIRE STARTED, CAUSING BURNS TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 24727750 ↗
• MalfunctionJan 30, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BURN SUFFERED BY CANINE (BACK, BETWEEN SHOULDER BLADES) DURING TPLO SURGERY BECAUSE OF ASSUMED USE OF MEGA SOFT PAD. VETERINARIAN MENTIONED THAT SHE SUSPECTED BURN IS DUE TO THE USE OF THE MEGA SOFT PAD DURING THE PROCEDURE BECAUSE OF THE PRESENTATION AND LOCATION OF THE BURN AND AWARENESS OF RECALL AND ISSUES WITH THE PAD - BUT COULD NOT CONFIRM OR DISPROVE USE OF THE MEGA SOFT PAD DURING THIS PARTICULAR PROCEDURE. CANINE IS STABLE AND BURN IS BEING TREATED.

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

  MAUDE report 24225320 ↗
• MalfunctionJul 15, 2024Arcing of Electrodes; Material Integrity Problem; Arcing of Electrodes; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE PAD HAD CAUGHT ON FIRE WHILE THE PATIENT WAS ON THE TABLE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739479 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PEDIATRIC TONSILLECTOMY THE PATIENT EXPERIENCED A SIGNIFICANT BURN ON THEIR RIGHT HIP. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 18237198 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY PROCEDURE A 4 YEAR SUFFERED A BURN. THE MEGASOFT PAD WAS ON THE POSTERIOR SIDE. THE QUARTER SIZE BLISTER WAS DISCOVERED WHEN THE PATIENT GOT HOME FROM THE PROCEDURE. THE PATIENT HAD FULL SIZE PAJAMAS ON DURING THE BRIEF PROCEDURE. THE BLISTER IS LOCATED ON THE BACK OF THE THIGH. IT IS UNKNOWN IF ANY INTERVENTION WAS GIVEN, BUT THE PATIENT IS DOING FINE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17261947 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY THAT TURNED INTO AN OPEN CASE THE PATIENT RECEIVED SIGNIFICANT BURNS ACROSS THE BACK AND SHOULDERS.

  Patient problems: Abrasion; Erythema; Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 16194100 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE PATIENT RECEIVED SIGNIFICANT BURNS ACROSS THE BACK AND SHOULDERS.

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

  MAUDE report 16156710 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ONE DAY POST OP TO A TUBE REMOVAL/ADENOIDECTOMY THE PATIENT HAD A QUARTER SIZE OVAL BURN ON LOWER BACK WITH TWO BLISTERS. DURING THE CASE TWO LAYERS WERE BETWEEN THE PATIENT AND THE PAD.

  Patient problems: Dehydration; Fever; Pain; Partial thickness (Second Degree) Burn

  MAUDE report 16112519 ↗
• MalfunctionOct 27, 2022Arcing of Electrodes; Unintended Electrical Shock; Arcing of Electrodes; Unintended Electrical Shock

  IT WAS REPORTED DURING A SPINE PROCEDURE THE BOVIE PENCIL WAS ARCING. THE STAFF IN THE ROOM PLACED A STICKY PAD ON THE PATIENT AND UNPLUGGED THE MEGASOFT PAD. THEY NOTICED WHEN THE ANESTHESIOLOGIST TOUCHED THE PATIENT'S HAND, IT DELIVERED A SHOCK. THE PATIENT WAS NOT IN CONTACT WITH METAL AS FAR AS THEY KNOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680505 ↗
• InjurySep 13, 2021Adverse 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 SUPERFICIAL BURN IN A CHILD IN THE LOWER BACK , IN THE CASE OF THE USE OF A MEGADYNE MEGA SOFT PLATE. LOT: 2116202. DURING THIS PROCEDURE, THE CONSUMABLES FOR MISTRAL-AIR HEATERS WERE USED. IN ADDITION, A SHEET WAS ALSO PRESENT. THE PRESENCE OF BETADINE ON THE SKIN.

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

  MAUDE report 12460497 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133726. One submission often covers many models, so check the product and lot details in each record.

• Z-0597-2024 · Dec 8, 2023 · Open, Classified
  Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
• 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