Mega Soft 0848Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10614559104859), received between Jan 20, 2023 and Aug 19, 2026 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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-0600-2024 · 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-2000-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Burn(s)

  MAUDE report 50329900 ↗
• InjuryJul 9, 2024Adverse 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 UNKNOWN PROCEDURE THE PATIENT SUFFERED FROM A BURN.

  Patient problems: Burn(s)

  MAUDE report 19700755 ↗
• InjuryJul 9, 2024Adverse 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 UNKNOWN PROCEDURE THE PATIENT SUFFERED FROM A BURN.

  Patient problems: Burn(s)

  MAUDE report 19700680 ↗
• InjuryJul 9, 2024Adverse 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 UNKNOWN PROCEDURE THE PATIENT SUFFERED FROM A BURN.

  Patient problems: Burn(s)

  MAUDE report 19700645 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PATIENT SUFFERED FROM A BURN.

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

  MAUDE report 19700624 ↗
• MalfunctionMar 11, 2024Electromagnetic Interference; Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock; Electromagnetic Interference; Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock

  IT WAS REPORTED THAT DURING A RIGHT HIP ARTHROPLASTY SURGERY, THE NEURO STIMULATOR SEEMED TO NOT FUNCTION WELL AND/OR IT WOULD HAVE INTERFERENCE. THE ANESTHESIOLOGIST (REMOVED) THEN CHANGED THE NEURO STIMULATOR AND WHEN SHE CAME TO PLUG IN THE 2ND SHE FELT A SHOCK 4TH FINGER TO THE LEFT HAND AND WHEN SHE LOOKED AT HER FINGER SHE NOTICED THAT SHE HAD A 1ST-DEGREE BURN. SHE ALSO NOTED UNUSUAL DISTURBANCES IN ECG. IT ALWAYS HAS INTERFERENCE WHEN USING ELECTROCAUTERY DURING SURGERY BUT THIS WAS DIFFERENT ACCORDING TO DR S. LOOKS LIKE ASYTOLY WHICH IS USUALLY NOT THE CASE.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 18874334 ↗
• MalfunctionSep 6, 2023Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC NEURO PROCEDURE THE OR STAFF WAS BURNED BY NASAL TEMPERATURE PROBE AND PROBE TEMPERATURE CONTINUED TO RISE, WHILE USING MEGASOFT PAD. IT WAS NOTED THAT THE PATIENT'S TEMPERATURE ELEVATED 1-2 DEGREES. IT WAS RECORDED VIA A NASAL TEMP PROBE AND THE STAFF CHANGED OUT THE MEGADYNE PAD WITH A STICKY PAD AND THE ISSUE STOPPED. THE PATIENT WAS UNDER FIVE KG WITH AN INFANT BAIR HUGGER BETWEEN THE MEGADYNE PAD AND THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 17690536 ↗
• MalfunctionAug 30, 2023Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ORTHO SPINE PROCEDURE THAT AFTER COMPLETING THE PROCEDURE IT WAS DISCOVERED THAT THE PATIENT HAD AN ALTERNATE SITE BURN ABOUT THE SIZE AND THICKNESS OF A PENCIL ERASER ON THEIR UPPER LEG WHILE THE PATIENT WAY LAYING PRONE. UPON FURTHER INSPECTION PER THE ORTHO SPINE MANAGER IT WOULD APPEAR THAT THE BOVIE PENCIL MAY NOT HAVE BEEN HOLSTERED PROPERLY AND PUNCTURED THROUGH THE DRAPES INTO THE PATIENTS LEG AND ACTIVATED. NO DEGREE OF BURN WAS PROVIDED TO THE SALES REP. TREATMENT OF THE BURN WAS NOT PROVIDED TO THE SALES REP.

  Patient problems: Burn(s)

  MAUDE report 17649906 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Temperature Problem; Unintended Electrical Shock; Adverse Event Without Identified Device or Use Problem; Temperature Problem; Unintended Electrical Shock

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AN EMPLOYEE OF ANESTHESIA RECEIVED A SLIGHT BLOW WHILE USING THE MONOPOLAR HOOK. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Burn(s); Electric Shock

  MAUDE report 17481459 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A REMOVAL OF ADENOIDS, A BURN WAS DISCOVERED ON THE PATIENTS BACK.

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

  MAUDE report 17134048 ↗
• MalfunctionJan 20, 2023Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN THEY USED THE MEGASOFT BLANKET, SPARKS FLEW AT THE TIP OF THE ELECTROCAUTERY. THE ELECTROCAUTERY'S HAVE CHANGED AND IT HAS CONTINUED TO GIVE PROBLEMS. THEY HAVE CHANGED THE MEGASOFT, AND IT HAS WORKED CORRECTLY. THERE WAS A SURGICAL DELAY BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213877 ↗

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-1998-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal 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-1999-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery