Mega 2000 0800Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10614559100936), received between May 16, 2018 and Feb 22, 2024 — classified as 12 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-2248-2024 · 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-1994-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2024Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PATIENT RECEIVED A BURN HAPPENED WHILE USING THE MEGASOFT PAD THE SURGERY WAS DELAYED. THE CASE HAS TO BE ABORTED DUE TO PATIENT BURN.

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

  MAUDE report 18760297 ↗
• InjuryJan 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. THE BLEEDING OCCURRED POST OP TO THE ORIGINAL PROCEDURE. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16196711 ↗
• InjuryJan 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. THE BLEEDING OCCURRED POST OP TO THE ORIGINAL PROCEDURE. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16196707 ↗
• InjuryJan 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. THE BLEEDING OCCURRED POST OP TO THE ORIGINAL PROCEDURE. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16196704 ↗
• InjuryJan 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. THE BLEEDING OCCURRED POST OP TO THE ORIGINAL PROCEDURE. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16196703 ↗
• InjuryJan 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. THE BLEEDING OCCURRED POST OP TO THE ORIGINAL PROCEDURE. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16196699 ↗
• InjuryJan 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. THE BLEEDING OCCURRED POST OP TO THE ORIGINAL PROCEDURE. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16196479 ↗
• InjuryJan 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. THE BLEEDING OCCURRED POST OP TO THE ORIGINAL PROCEDURE. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16196363 ↗
• InjuryJun 2, 2022Adverse 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 BREAST IMPLANTATION THAT THE POTENTIAL 0800 COULD BE RELATED TO A BURN.

  Patient problems: Burn(s); Deformity/ Disfigurement; Pain

  MAUDE report 14575657 ↗
• InjuryApr 21, 2020Improper or Incorrect Procedure or Method

  TITLE: INTRAOPERATIVE ELECTRICAL BURN CAUSED BY STAINLESS TUBE TREE WITH NONCONTACT ELECTROSURGICAL GROUND -A CASE REPORT. AUTHORS: SUNG SIK PARK, JUNG A LIM, AND JIN-SEOK YEO. CITATION: ANESTH PAIN MED 2014; 9: 274-276. THE AUTHORS DESCRIBED AN ACCIDENTAL INTRAOPERATIVE ELECTRICAL BURN DUE TO IMPROPER USE OF NONCONTACT GROUNDING PAD. A (B)(6)-YEAR-OLD FEMALE PATIENT WITH RECTAL CANCER AND RECTOVAGINAL FISTULA PRESENTED FOR AN ELECTIVE ABDOMINOPERINEAL RESECTION, HYSTERECTOMY, VAGINA POSTERIOR WALL RESECTION. DURING THE PROCEDURE, A THIRD DEGREE BURN ON THE THIRD FINGER OF LEFT HAND WAS FOUND. THE PATIENT¿S LEFT THIRD FINGER WAS CONTACTED TO STAINLESS TUBE TREE ON THE HEAD SIDE OF OPERATION TABLE DURING PRONE POSITION AND SCORCHED STAIN WAS FOUND ON THE TUBE TREE. A NONCONTACT ELECTROSURGICAL GROUND (MEGADYNE 2000; ETHICON) WAS SET PRIOR TO SURGERY BENEATH THE PATIENT. THE GROUND WAS SLIPPED IN PLASTIC SHEATH AND COVERED LINEN SHEET WITHOUT CONTACT OF THE PATIENT. THE BURN SITE WAS MANAGED WITH REGULAR STERILE DRESSINGS AND DID NOT REQUIRE ADDITIONAL SURGICAL PROCEDURE. AFTER THIS EVENT, WE CHANGED TUBE TREE TO NON-CONDUCTING MATERIAL AND INSULATED OTHER METALLIC OBJECTS ON THE OPE

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 9983508 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OP A PROCEDURE, THE PATIENT HAD A CHEMICAL BURN WOUND ON THE RIGHT FORE ARM (MSDS CAUSTIC 19% NAOH BULK). THERE WERE BILATERAL GLUTEAL BURNS AFTER USE OF DWN COAGULATION DEVICE IN COMBINATION WITH FORCE FX "METRONIC" + M2K09 (LOT 163908). SURGEON HAD TO STOP THE SURGERY AND TREAT THE BURNS. A CONSERVATIVE TREATMENT WAS INITIALLY SUGGESTED. ON (B)(6) 2018 THE SURGEON WAS INFORMED ABOUT THE ISSUE BY TELE-MEDICINE (PICTURES + DESCRIPTION OF THE INCIDENT). ON (B)(6) 2018 THERE WAS A CONSULTATION AND ON (B)(6) THE DECISION WAS MADE TO HAVE THE PARTIAL EXCISION AND CLOSURE + PARTIAL TE AND SSG. THE PROCEDURE WAS EXECUTED AS INTENDED; HOWEVER, POST-OP THE PATIENT MENTIONED THAT HE HAD PAIN IN BILATERAL GLUTEAL. INSPECTION SHOWED 2 RED, SWOLLEN ZONES AT THE LEVEL OF THE BUTTOCKS. THE SKIN WAS RINSED AND FLAMINAL WAS ADDED. PAIN MEDICATION WAS PROVIDED BY THE ANESTHETIST. PATIENT STABLE, BUT HAS PAIN.

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

  MAUDE report 8233610 ↗
• MalfunctionNov 29, 2018Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MEGASOFT PAD WAS RECEIVED WITH NO SERIAL NUMBER OR EXPIRATION DATE PRINTED ON THE PAD. NO PATIENT INVOLVEMENT OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118189 ↗
• InjuryMay 16, 2018Fire

  IT WAS REPORTED THAT, DURING A GENERAL SURGERY, THE HOSPITAL HAD A PATIENT CATCH FIRE. THE ELECTROSURGICAL CIRCUIT WAS: FORCE TRIAD- MEGA 2000 AND PRIM PENCIL. THE FIRE BEGAN WHEN THE SURGEON PUSH THE CUT BUTTON, IN THE BEGINNING OF THE SURGERY.

  Patient problems: Burn, Thermal

  MAUDE report 7519182 ↗