Mega Soft 0846Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10614559104248), received between Oct 24, 2018 and Sep 20, 2024 — classified as 16 injuries, 7 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-0598-2024 · 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-2001-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 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 A THIRD-DEGREE BURN. A SURGICAL INTERVENTION WAS REQUIRED. THE IMPACTED DEVICE WAS USED BY THE SURGEON WHEREAS IT WAS ALREADY EXPIRED (SINCE APRIL 2021).

  Patient problems: Full thickness (Third Degree) Burn; Pain

  MAUDE report 20266062 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CABG PROCEDURE, THE PATIENT SUFFERED A BURN.

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

  MAUDE report 19710639 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC SURGEON REPORTED THE PATIENT SUFFERED A BURN. AT THE TIME OF THE CALL THE REP WAS WAITING TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19642877 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE THE MEGASOFT BURN POST SURGERY ON THE RIGHT BUTTOCK OF THE PATIENT. QUITE DANGEROUSLY BURNT WITH BURNING SEVERAL LAYERS.

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

  MAUDE report 19297119 ↗
• MalfunctionSep 8, 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 A PECTUS SURGERY ON A PEDIATRIC PATIENT. USE OF MEGASOFT CODE 0846 COVERED WITH A SHEET. INITIALLY THE PATIENT WAS POSITIONED ON HIS SIDE AND THEN SUPINE PLACING BETWEEN THE PATIENT AND THE MEGASOFT TWO BRACES FROM SHOULDERS TO SIDE. THEREFORE THE PATIENT RESTED ON THE MEGASOFT ONLY WITH THE BUTTOCKS AND THE FIRST PORTION OF THE THIGHS. AT THE END OF THE INTERVENTION, NO ANOMALIES WERE REPORTED. THE PATIENT HAD AN EPIDURAL AND MORPHINE AND WAS BEDRIDDEN MUCH LONGER THAN EXPECTED. AFTER 5 DAYS, NEAR THE COCCYX, A DARK RADIAL-SHAPED LESION WAS NOTED WITH AN EXCORIATED PORTION. THE APPEARANCE WAS THAT OF A BURN. THE ADVERSE EVENT PROBABLY OCCURRED INTRAOPERATIVELY BUT WAS RECOGNIZED AT THE TIME OF THE PATIENT'S DISCHARGE,

  Patient problems: Burn(s)

  MAUDE report 17710516 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CABG THE PATIENT SUFFERED A BURN WHILE USING MEGASOFT PATIENT RETURN ELECTRODE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17543365 ↗
• InjuryAug 14, 2023Adverse 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 A BURN DUE TO MEGASOFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A PATIENT BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17543061 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TONSILLECTOMY WITH ADENOID REMOVAL THE 5 Y/O, PATIENT URINATED BEFORE THE PROCEDURE. WET SHEET REMOVED, CLEANED UP WITH INCONTINENCE CLEANSER (STRYKER PRODUCT). PLACED CLEAN SHEETS BETWEEN PATIENT AND PAD, LOWEST LEVEL OF SHEETS WERE NOT REMOVED, STILL MOIST. THE PATIENTS PRESENTED WITH A "GOOD SIZE" BURN ON THEIR BUTTOCKS. DEGREE OF BURN WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16904517 ↗
• MalfunctionAug 26, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A CHOLE PROCEDURE THE SURGEON EXPRESSED THAT HER BOVIE WASN¿T WORKING, SHE FELT LIKE SHE WAS NOT WAS GETTING ENOUGH POWER, COAG EFFECT, SO POWER LEVEL WAS ADJUSTED FROM 3 TO 5, AND THEN HEMOSTASIS WAS ACCEPTABLE REMAINDER OF CASE. ALL WAS WORKING WELL AT POWER LEVEL 5 WITHOUT BLEEDING ISSUES. ARCHING EVENTS WITH MONOPOLAR. SWITCHED MEGA SOFT PAD TO STICKY PAD AND THAT RESOLVED THE ISSUE. VIODV GENERATOR FOR ROBOTIC PROCEDURES WERE USED. THERE WAS A PINK PAD BETWEEN THE MEGASOFT AND THE PATIENT. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300472 ↗
• MalfunctionAug 26, 2022Electromagnetic Interference; Arcing of Electrodes; Electromagnetic Interference; Arcing of Electrodes

  IT WAS REPORTED THAT DURING THE CHOLE PROCEDURE, THE DOCTOR EXPERIENCED AN ARCING EVENTS WITH THE MONOPOLAR INSTRUMENT. THE BOVIE SETTINGS WERE TURNED UP FROM THREE TO FIVE BECAUSE THE SURGEON DIDN¿T FEEL SHE WAS GETTING ENOUGH POWER, COAG EFFECT. THEY SWITCHED FROM MEGA SOFT PAD TO STICKY PAD, IT RESOLVED THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300304 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CABAG PROCEDURE THAT NINE HOURS POST OP THAT THE PATIENT COMPLAINED OF PAIN ON THEIR BACK WHERE A ¿BOIL LIKE BLISTER¿ ABOUT THE SIZE OF THE PALM OF A HAND WAS FOUND. TREATMENT WAS NOT PROVIDED TO THE SALES REP.

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

  MAUDE report 15083597 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OP OF AN UNKNOWN PROCEDURE THIRTY MINUTES IN RECOVERY IT WAS NOTICED BY THE PARENTS THAT THE PATIENT HAS A BURN ON THEIR ELBOW. STAFF DID NOT NOTICE THE MARK BEFORE OR AFTER THE PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 14469558 ↗
• MalfunctionFeb 23, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT WHILE THE SURGEON WAS PERFORMING A CABG WITH A MEGADYNE ELECTRO SURGICAL AND MEGA SOFT ELECTRODE. THE ESS PENCIL TO THE DEBOKI SET A PIECE OF THE GAUZE ON FIRE. THE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584359 ↗
• MalfunctionAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP OF A CABG PROCEDURE. CABG PT ON BYPASS. HEALTHY BMI. LARGE BURN ON BACK WHICH WAS NOTICED POSTOP DAY 2. CORE BIOPSY CONSISTENT WITH BURN. THE PREP WAS A DILUTED CHLORHEXIDINE WASH (NON-STERILE), DRIED WITH STERILE TOWELS, THEN DURAPREP APPLIED STERILELY. PREP AREA WAS NECK TO ANKLES ANTERIOR. THEY DO NOT CIRCUMFERENTIALLY PREP THE LEGS. IT IS UNKNOWN IF THE PATIENT EXPERIENCED A POST-OP DEVICE MALFUNCTION.

  Patient problems: Burn(s)

  MAUDE report 12333360 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING LAPAROSCOPIC SURGERY FOR TREATMENT OF CERVICAL CANCER A FEMALE PATIENT, (B)(6) YEAR-OLD, WAS BURNED AT THIGH; BUTT, AND BACK USING THE MEGASOFT CODE 0846, LOT: 210808001, EPX 04/2023. THE SET UP ORDER WAS OPERATING TABLE--> MEGASOFT PAD / NYLON SHEET / 2 LAYERS OF DRAW SHEET / PATIENT. THE MEGASOFT PAD WAS CONNECTED TO THE AESCULAP AG . THE CURRENT PATIENT 'S HEALTH IS THAT THE BURN HAS TURNED TO BLISTERS, THE PATIENT WAS TREATED WITH PANTHENOL PRODUCT (DEXPANTHENOL 5%).

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

  MAUDE report 12128805 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LOWER ANTERIOR RESECTION WAS PERFORMED ON A FEMALE PATIENT, (B)(6) YEARS OLD, A DAY LATER, DOCTORS FOUND SHE HAD MINOR BURNS ON HER BACK. THEY USED MEDICINE TO TREAT THESE BURNS. AND AFTER 4 DAYS, ONE BURN NEARLY DRY. DURING THE PROCEDURE, MEGASOFT DUAL CORD 0846 HAS BEEN USED. THE SET UP OF MEGASOFT IN OR WAS THERE ARE A NYLON LAYER AND A FABRIC LAYER ABOVE AND BELOW THE PAD. AFTER EACH PROCEDURE, THE UPPER NYLON AND FABRIC LAYER ARE REMOVED AND THE PAD IS CLEANED WITH WATER, AND DRIED WITH COTTON PAD. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> YES.

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

  MAUDE report 11655658 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MEGACOLON PROCEDURE, A PATIENT ((B)(6) MONTHS BABY) GOT A BURN AFTER SURGERY THAT USED MEGASOFT UNIVERSAL.

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

  MAUDE report 11612908 ↗
• InjuryMar 3, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A PARP-AORTIC LYMPH NODE DISSECTION WITH DIATHERMY THE PATIENT WENT INTO CARDIAC ARREST. THE IMPRESSION THAT THE NURSE GAVE IS IT WAS SUSPECT OR BLAMED ON THE MGEASOFT MAT BEING TRIAL IN THE OR. THE PATIENT WAS REVIVED ON THE TABLE AND SURVIVED. SURGERY DELAYED.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404052 ↗
• MalfunctionDec 14, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE UPPER SHEATH OF MEGASOFT IS TORN AND NOT WORKING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11004353 ↗
• InjuryOct 27, 2020Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: UNINTENDED ICD DISCHARGE IN A PATIENT UNDERGOING BLADDER TUMOR RESECTION UTILIZING MONOPOLAR CAUTERY AND FULL-BODY RETURN ELECTRODE. AUTHORS: RYAN J. LEFEVRE, MD; GEORGE H. CROSSLEY, MD; LAURA L. SORABELLA, MD; KARA K. SIEGRIST, MD; SUSAN S. EAGLE, MD. CITATION: J CARDIOVASC ELECTROPHYSIOL. 2020;1-3; DOI: HTTPS://DOI.ORG/10.1111/JCE.14699. THIS IS A CASE REPORT CONCERNING A (B)(6)-YEAR-OLD MALE PATIENT WITH A HISTORY OF ISCHEMIC CARDIOMYOPATHY WITH A LEFT PECTORAL SINGLE-CHAMBER IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) FOR PRIMARY PREVENTION OF SUDDEN CARDIAC DEATH PRESENTED FOR TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT). MONOPOLAR CAUTERY WITH A FULL-BODY RETURN ELECTRODE PAD (MEGADYNE MEGASOFT; ETHICON) WAS USED DURING THE PROCEDURE. THE INVOLUNTARY PATIENT MOVEMENT WAS NOTED, WHICH WAS INITIALLY FELT TO BE THE INADEQUATE DEPTH OF ANESTHESIA. WHEN THE MOVEMENT CONTINUED DESPITE INCREASING THE DEPTH OF ANESTHESIA, IT WAS NOTED THAT THE MOVEMENTS CORRELATED WITH ELECTROCAUTERY USE. AT THIS POINT, THE MOVEMENTS WERE SUSPECTED TO BE CAUSED BY AN INAPPROPRIATE ICD DISCHARGE. ELECTROCAUTERY USE WAS SUSPENDED AND THE PROCEDURE WAS AB

  Patient problems: Electric Shock

  MAUDE report 10743760 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A HEPATECTOMY A BLISTER WAS FORMED ON THE BACK OF A PATIENT AFTER PERFORMING THE HEPATECTOMY WITH THE USE OF MEGASOFT UNIVERSAL DUAL PATIENT RETURN ELECTRODE. THE PATIENT WAS IN A SUPINE POSITION DURING THE WHOLE SURGERY. DURING THE SURGERY, A WEAKER ELECTROSURGICAL EFFECT WAS EXPERIENCED BY THE SURGEON, HENCE, A HIGHER POWER SETTING ON THE ELECTROSURGICAL GENERATOR WAS APPLIED COMPARED THE STANDARD PRACTICE. NO SUPERFICIAL DAMAGE WAS OBSERVED ON THE MEGASOFT RETURN ELECTRODE AND CABLES. THE PATIENT SUFFERED FROM A BURN AND BLISTER FORMED (~20CM),

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 10434423 ↗
• MalfunctionFeb 7, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP OF AN AORTO BI-FEMORAL BYPASS, ON THE BACK OF THE PATIENT A BURN WAS NOTICED. UNKNOWN EXACTLY IF THE PAD WAS THE CAUSE OF THE BURN TO THE PATIENT. PATIENT WAS NOTICED TO HAVE EXTENSIVE FIRST AND SECOND DEGREE BURNS ON PATIENTS ENTIRE BACK. THEY WERE USING BOTH AN UNDER BODY AND OVER BODY BEAR HUGGER, WHICH BOTH TESTED FINE FOR THE BIOMED. THE BIOMED SAID THEY USED TWO COVIDEN ESUS AS WELL.

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

  MAUDE report 8318359 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW DAYS AFTER A CABG PROCEDURE, THERE WAS A PATIENT BURN INJURY WHERE THE MEGASOFT PAD WAS USED.

  Patient problems: Burn(s)

  MAUDE report 8002360 ↗

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-1999-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
• Z-1998-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
• Z-2000-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery