Force FX Force FX-8CASRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884524002637), received between Sep 6, 2017 and Mar 7, 2025 — classified as 3 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (7 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SUPERFICIAL LIPOMA PROCEDURE, THE DEVICE SPARKED. THERE WAS A PATIENT BURN THAT LEAD TO A SERIOUS PATIENT INJURY. THE PATIENT WAS TRANSFERRED TO A DIFFERENT MEDICAL CENTER AND THE HOSPITALIZATION TIME WAS EXTENDED.

  Patient problems: Burn(s)

  MAUDE report 21551879 ↗
• MalfunctionAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE PACEMAKER PROCEDURE, THE PATIENT HAD LEFT SHOULDER BURN (PAINLESS LARGE-AREA REDNESS ON THE LEFT).

  Patient problems: Burn(s)

  MAUDE report 19943544 ↗
• MalfunctionAug 5, 2024Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE POST- PACEMAKER SURGERY PROCEDURE, THE PATIENT HAD A LARGE FIRST DEGREE SKIN BURN ON THE LEFT SHOULDER AND A SMALL AREA OF PAINLESS REDNESS AT THE JUNCTION OF THE BACK AND NECK THAT WAS FOUND AFTER REPOSITIONING THE PATIENT. A NON-MEDTRONIC REM PAD WAS USED. THE UNIT HAD ISSUE WITH MONOPOLAR MODE (VALLEYLAB MODE) DURING THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Superficial (First Degree) Burn

  MAUDE report 19912682 ↗
• MalfunctionApr 24, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT DID NOT SIGNAL PROBLEMS IN THE REM (RETURN ELECTRODE MONITOR) SYSTEM DURING THE ENTIRE PROCEDURE. THE ELECTRODE DEDICATED TO PATIENTS IN ACCORDANCE WITH THE GUIDELINES WITH THE REM SYSTEM, ADHERED TO ITS ENTIRE SURFACE. THE SURGICAL SITE WAS LOCATED ON THE LOWER LIMB. THE ELECTRODE WAS GLUED IN THE LATERAL AREA OF THE ABDOMEN. THE PATIENT WAS LYING ON A DRY OCCUPANCY OF THE OPERATING TABLE (AS ASSESSED BY THE OPERATING TEAM). THE PATIENT HAD AN INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19176147 ↗
• MalfunctionJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PATIENT HAD BURN. THE REM CABLE, PAD AND SURGICAL PEN USED WITH THE DEVICE WERE NOT ORIGINAL. FAILURE TO APPLY THE CORRECT PAD USAGE PROCEDURE IS THE CAUSE OF PATIENT BURNS.

  Patient problems: Burn(s)

  MAUDE report 18576065 ↗
• MalfunctionJun 10, 2023Failure to Deliver Energy; Connection Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Failure to Deliver Energy; Connection Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD NO COAGULATION AND HAD MELTED. THEY WONDER WHY THE PLASTIC WAS MELTED WHETHER THERE WAS A CRACK BEFORE SURGERY OR THE UNIT'S COAGULATION POWER SETTING WAS FAILED. PHOTO WAS SUBMITTED SHOWING A DAMAGED INSULATION. PATIENT HAD BLEEDING BUT BLOOD TRANSFUSION WAS NOT NEEDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17102039 ↗
• MalfunctionMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PATIENT WAS BURNED WHILE USING A NON-MEDTRONIC ELECTROSURGICAL PLATE AND TWO BUTTONS PENCIL WITH THE GENERATOR.

  Patient problems: Burn(s)

  MAUDE report 16545763 ↗
• MalfunctionDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THERE WAS PATIENT BURN.

  Patient problems: Burn(s)

  MAUDE report 16062782 ↗
• MalfunctionSep 8, 2022Inaccurate Delivery; Connection Problem; Inaccurate Delivery; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD ERROR, IT ALREADY DISPLAYED GREEN AFTER CONNECTING THE NEUTRAL ELECTRODE CABLE. THE LIGHT WAS ALREADY GREEN WHEN JUST THE CABLE WITHOUT A REM PAD WAS ATTACHED TO THE PATIENT. THE RETURN ELECTRODE MONITORING (REM) SOCKET DID SHOW A STRANGE BEHAVIOR. WITH THE ORIGINAL REM CABLE, IT IS SAID THAT IT DID NOT FUNCTION PROPERLY. REPLACING THE REM SOCKET AND CALIBRATING THE UNIT SOLVED THE PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382871 ↗
• MalfunctionJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD BURN.

  Patient problems: Burn(s)

  MAUDE report 14801461 ↗
• MalfunctionJan 7, 2022Break; Self-Activation or Keying; Connection Problem; Break; Self-Activation or Keying; Connection Problem

  ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS GRAFT SURGERY (CABG), THE MACHINE MADE AN ES-PENCIL (ELECTROSURGICAL) SELF-ACTIVATION. CUSTOMER UNABLE TO USE HOLSTER AND PATIENT HAD VERY MINIMAL-SIZED UPPER BODY INJURY AND DISCOVERED ONCE IT HAPPENED. DID SOME CHECK UP ON THE GENERATOR WHICH SHOWED OUTPUT FROM INACTIVE PORT. THE PROCEDURE WAS COMPLETED WITH THE SAME MACHINE, BUT ONLY ONE ES-PENCIL.

  Patient problems: Burn(s)

  MAUDE report 13188562 ↗
• MalfunctionDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PATIENT GOT BURNED IN THE EYELASH.

  Patient problems: Burn(s)

  MAUDE report 13024783 ↗
• MalfunctionNov 19, 2021Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE UNIT HAD NO ERROR OR MALFUNCTION. THE PATIENT LEAD AND PAD FROM ANOTHER MANUFACTURER HAD OVERHEATED WHICH CAUSED MELTING AND PATIENT HAD A SMALL FIRST DEGREE BURN. ATTACHED WAS THE PHOTO OF THE PATIENT'S LEG AND THERE WAS NO TREATMENT APPLIED.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 12846656 ↗
• MalfunctionOct 14, 2021Device Alarm System; Image Display Error/Artifact; Self-Activation or Keying; Device Displays Incorrect Message; Connection Problem; Electrical Shorting; Device Alarm System; Image Display Error/Artifact; Self-Activation or Keying; Device Displays Incorrect Message; Connection Problem; Electrical Shorting

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT WAS NOT WORKING, FLASHED LIGHTS, HAD AN ALARM AND HAD AN ERROR LOG 17, 166 AND 164. THE AUTOBIPOLAR ACTIVATED WHEN SHORTED AND THE CUT DISPLAY WAS RUPTURE. REPLACED WITH ANOTHER SIMILAR DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12634866 ↗
• MalfunctionMay 27, 2021Inaccurate Delivery; Device Displays Incorrect Message; Inaccurate Delivery; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, RANDOM DEFECT OF PATIENT PLATE. GOES GREEN EVEN WITHOUT A PLATE. THE DATE OF THE ERROR LOG IS CORRUPTED. ERROR 160 IN THE LOG IMMEDIATELY BEFORE THE CORRUPTED DATE. THE UNIT ALSO HAD WORN K2 RELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893602 ↗
• MalfunctionFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE, THE UNIT'S HIGH SETTINGS IN PURE CUT AND FULGURATION, BOTH IN 100W, CAUSED BLISTERING, 2ND DEGREE 3-4SM BY 8-10SM BURN TO THE PATIENT. THIS WAS TREATED THERAPEUTICALLY WITH NO NEED TO ADDITIONAL SURGERY. A PHOTO HAD BEEN SUBMITTED SHOWING THE BURN SITE ON THE PATIENT'S BUTTOCK.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11342494 ↗
• MalfunctionFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A BREAST AUGMENTATION AND LIFT PROCEDURE, THE DEVICE CLEANSING AND DISINFECTION WERE PERFORMED WITH NON-EVAPORATED ALCOHOLIC DISINFECTANT. USING DIATHERMY, A REDNESS AND RUBBING WAS OBSERVED IN THE SURGICAL AREA. THE DEVICE HAD NO CAUSAL RELATIONSHIP TO ISSUE.

  Patient problems: Skin Discoloration

  MAUDE report 11301001 ↗
• MalfunctionJan 8, 2021Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING TESTING, THE UNIT CROSS COUPLING TEST FAILED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11138710 ↗
• MalfunctionDec 30, 2020Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT OUTPUTS EVEN WHEN THE BUTTON WAS NOT PRESSED. THE GENERATOR WAS REPLACED BY ANOTHER ONE AND IT WORKED PROPERLY. THERE WAS A MINOR SCARS, BUT THERE WAS NO PROBLEM AT PRESENT.

  Patient problems: Scar Tissue

  MAUDE report 11095413 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PACEMAKER IMPLANTATION PROCEDURE, ON THE FIRST CUT THE DRAPE (SHEET) THAT COVERED THE PATIENT BEGAN TO BURN, THEN THE DRAPE THAT SEPARATES THE OPERATING FIELD FROM THE ANESTHESIA STATION AND ALSO THE PATIENT'S CAP BEGAN TO BURN. A COMPETITOR'S NEUTRAL ELECTRODE HAD BEEN LOCATED ON PATIENT`S LOWER BACKS, MONOPOLAR PEN HAS BEEN USED ON PATIENT`S LEG. THE PATIENT SUFFERED SECOND TO THIRD DEGREE BURNS (5% OF THE BODY) ON THE BACK, SHOULDER, ARM, NECK AND EAR. THUS LEADING TO PATIENT'S SEVEN DAYS EXTENDED HOSPITALIZATION, RE-OPERATION/ADDITIONAL SURGERY AND BEING RELOCATED TO THE CARE OF THE BURN TREATMENT CENTER. THE TREATMENT WAS STILL CONSERVATIVE (BANDAGES OF THE AFFECTED AREAS). ANY OTHER INTERVENTION WILL BE DECIDED AFTER 10 DAYS FROM THE ACCIDENT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 11076447 ↗
• MalfunctionFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE UNIT CAUSED BURN WHEN THE NURSE ATTACHED THE REM PAD TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 9756690 ↗
• MalfunctionFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE TOTAL LAPAROSCOPIC NEPHRECTOMY PROCEDURE, THE PATIENT HAD BLISTER AND RASH LEVEL ON SACRUM AND BUTTOCKS.

  Patient problems: No Code Available; Rash

  MAUDE report 9750422 ↗
• MalfunctionFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD A BLISTER AND RASH IN THE GLUTEAL FOLD. CONSULTATION WITH A COSMETIC SURGEON RECOMMENDED CONTINUOUS LOCAL CARE AND THERE WAS NO INDICATION FOR ANTIBIOTIC THERAPY AS LONG AS THE ERYTHEMA DOES NOT PROGRESS AND THE PATIENT IS APYRETIC.

  Patient problems: No Code Available; Rash

  MAUDE report 9717869 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE CAUSED 2ND DEGREE BURN, ESCHAR TREATED WITH NECROTIC TISSUE RESECTION RE-OPERATION.

  Patient problems: Fever; No Code Available; Pain; Partial thickness (Second Degree) Burn; Tissue Damage

  MAUDE report 9710930 ↗
• MalfunctionSep 23, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PATIENT GOT SECOND DEGREE BURN WITH THE REM PAD. THE PROCEDURE WAS COMPLETED WITH REVISION AS A RESULT OF PERITONITIS. THE WOUND WAS WASHED AND SMEARED WITH FLAMINAL HYDRO TWICE A DAY.

  Patient problems: Burn(s)

  MAUDE report 9105170 ↗