Force FX FORCEFX8CRecalls & reported problems

Summary

The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 10884524001562), received between Apr 11, 2017 and May 29, 2026 — classified as 15 injuries, 243 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (84 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 258 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Failure to Calibrate; Arcing; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING HEMORRHOID SURGERY, THE GENERATOR HAD SUDDENLY EMITTED A LARGE SPARK, RESULTING IN A BURN TO THE PATIENT¿S NORMAL SKIN TISSUE. AFTER THE EVENT OCCURRED, MEDICAL STAFF IMMEDIATELY TERMINATED THE PROCEDURE AND PROVIDED EMERGENCY TREATMENT TO THE BURNED AREA AND FOLLOWED BY MEDICAL OBSERVATIONS. PRELIMINARY ACTION WAS THE DEVICE WAS SENT FOR THIRD-PARTY TESTING, DURING WHICH IT FAILED TO PASS INSPECTION AND DISPLAYED ERROR CODE 161. THE DEVICE WAS TAKEN OUT OF SERVICE, AND THE MANUFACTURER WAS REQUESTED TO PERFORM FURTHER INSPECTION AND REPAIR.

  Patient problems: Burn(s)

  MAUDE report 25332421 ↗
• MalfunctionMar 18, 2026Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT-SIDED RADICAL MASTECTOMY, A NON-MEDTRONIC ABLATION ELECTRODE WAS CONNECTED TO THE HIGH-FREQUENCY ELECTROSURGICAL UNIT, THE CHIEF SURGEON REQUESTED THAT THE ABLATION ELECTRODE BE SWITCHED FROM HAND CONTROL TO FOOT CONTROL. WHILE REMOVING THE CONVERTER PLUG, THE CIRCULATING NURSE'S LEFT INDEX FINGER WAS BURNED, WITH A BLISTER OBSERVED LOCALLY. IMMEDIATE ICE APPLICATION WAS GIVEN. THE SURGERY WITH THE PATIENT WAS COMPLETED SUCCESSFULLY. PHOTO RECEIVED SHOWED THAT THE MONOPOLAR PORT 1 WAS UTILIZED.

  Patient problems: Burn(s)

  MAUDE report 24630621 ↗
• MalfunctionFeb 15, 2026Self-Activation or Keying; Connection Problem

  IT WAS REPORTED THAT DURING THYROIDECTOMY, THE BIPOLAR ELECTROCAUTERY CONTINUED TO FIRE OUT. INVESTIGATION REVEALED THAT THE BIPOLAR FOOT PEDAL FAILED TO RETURN PROPERLY. AN ENGINEER WAS CONTACTED FOR REPAIRS AND THE ISSUE AFFECTED THE SURGICAL PROCEDURE. AFTER THE ENGINEER REPLACED THE BIPOLAR FOOT PEDAL THE EQUIPMENT FUNCTIONED NORMALLY.

  Patient problems: Insufficient Information

  MAUDE report 24341685 ↗
• MalfunctionJan 6, 2026Energy Output Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SEPTOPLASTY UNDER GENERAL ANESTHESIA FOR A NASAL SEPTUM DEVIATION, THE SURGEON ATTEMPTED BIPOLAR ELECTROCAUTERY FOR HEMOSTASIS, BUT THERE WAS NO RESPONSE FROM THE ELECTROCAUTERY FOOT PEDAL AFTER EXCISION OF THE DEVIATED CARTILAGE. IMMEDIATE COTTON PAD COMPRESSION WAS USED FOR HEMOSTASIS, BUT THE SURGERY COULD NOT PROCEED NORMALLY AND UNABLE TO STOP THE BLEEDING. THE SURGEON PAUSED THE OPERATION AND WAITED, RESTARTING THE DEVICE DID NOT RESOLVE THE ISSUE. EMERGENCY COORDINATION WAS UNDERTAKEN TO REPLACE THE DEVICE AND COMPLETE THE SURGERY, AND THE EQUIPMENT DEPARTMENT WAS NOTIFIED FOR TIMELY REPAIR. THIS EVENT NOT ONLY AFFECTED THE PROGRESS OF THE OPERATION BUT ALSO PROLONGED THE DURATION OF ANESTHESIA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23973416 ↗
• MalfunctionNov 4, 2025Failure to Deliver Energy; Failure to Calibrate; Connection Problem; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Failure to Calibrate; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A REMOVAL OF THE GALLBLADDER ON A GANGRENOUS CHOLECYSTECTOMY, THERE WAS ELECTRIC LEAKAGE AT THE WORKING END OF THE BIPOLAR COAGULATION FORCEPS, RESULTING IN DAMAGE TO THE SURROUNDING NORMAL LIVER TISSUE. THE SURGERY WAS IMMEDIATELY PAUSED FOR INSPECTION, WHICH REVEALED A MALFUNCTION IN THE OUTPUT OF THE HIGH-FREQUENCY ELECTROSURGICAL GENERATOR. ANOTHER HIGH-FREQUENCY ELECTROSURGICAL GENERATOR WAS PROMPTLY CONNECTED TO THE BIPOLAR COAGULATION FORCEPS TO CONTINUE THE OPERATION, WHILE MONITORING CHANGES IN THE LIVER TISSUE. SINCE NO MEDICATION OR OTHER INTERVENTION WAS APPLIED TO THE DAMAGED LIVER TISSUE, THE NURSE WAS INSTRUCTED TO CLOSELY OBSERVE THE PATIENT AFTER SURGERY.

  Patient problems: Tissue Breakdown

  MAUDE report 23465578 ↗
• MalfunctionOct 21, 2025Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT DURING A PROCEDURE, UNIT'S REM WAS ABNORMAL. THE REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345121 ↗
• MalfunctionSep 19, 2025Inaccurate Delivery; Failure to Calibrate; Inaccurate Delivery; Failure to Calibrate

  IT WAS REPORTED THAT PRIOR TO USE, UNIT WAS FAILING THE HIGH-RESISTANCE TEST (>135 OHMS). IT WAS ONLY TRIGGERING THE LOW-RESISTANCE ALARM. CONFIRMED THE OSCILLATOR WAS FUNCTIONING AT 82KHZ AND RE-CALIBRATED REM CALIBRATION VALUES. IT STILL DID NOT ALARM WHEN ADDED RESISTANCE WITH THE DECADE BOX. TRIED A DIFFERENT DECADE BOX AND CONFIRMED BOTH WERE PROPERLY FUNCTIONING WITH A MULTIMETER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093077 ↗
• MalfunctionJul 22, 2025Connection Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Connection Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, AN INCIDENT OCCURRED WITH THE NON-MEDTRONIC MONOPOLAR CABLE. THIS SHORT-CIRCUITED THE CABLE, FRACTURING IT AND CAUSING A MINOR BURN TO PART OF THE DOCTOR'S SURGICAL GOWN AND THE PATIENT HAD A BURN IN THE SKIN.

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

  MAUDE report 22563080 ↗
• InjuryJun 16, 2025Failure to Calibrate; Connection Problem; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SURGICAL REMOVAL OF A MALIGNANT AND/OR BENIGN NEOFORMATION, THE UNIT WAS USED IN A DISCONTINUOUS MANNER THROUGHOUT THE PROCEDURE. A FEW HOURS AFTER SURGERY, AN EXTENSIVE BLISTER APPEARED ON THE PATIENT'S LEFT LEG. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT(ICU). THE UNIT HAD MONOPOLAR MODE ISSUE (VALLEYLAB MODE) AND CURRENT LEAKAGE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22211956 ↗
• MalfunctionMar 3, 2025Energy Output Problem; Device Remains Activated; Intermittent Energy Output; Energy Output Problem; Device Remains Activated; Intermittent Energy Output

  IT WAS REPORTED THAT THE UNIT¿S BIPOLAR FOOT PEDAL HAD A DAMAGED CABLE, CAUSING THE ACTIVATION TO FUNCTION RANDOMLY DUE TO A BROKEN WIRE INSIDE THE CABLE SLEEVE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT INITIATION OF THE FUNCTIONAL PROTOCOL, NOTING THAT DURING THE CROSS COUPLING TEST, THE PURE CUT POWER REMAINS ACTIVATED ONCE THE BUTTON IS NO LONGER PRESSED.

  Patient problems: Insufficient Information

  MAUDE report 21510352 ↗
• MalfunctionMar 3, 2025Inappropriate/Inadequate Shock/Stimulation; Failure to Calibrate; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Calibrate; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE ELECTROCOAGULATION HOOK FOR HEMOSTASIS HAD LEAKAGE OF ELECTRICITY, AND THE ANES THESIOLOGIST'S HAND WAS ELECTROCUTED AND A BLISTER FORMED.

  Patient problems: Electric Shock; Partial thickness (Second Degree) Burn

  MAUDE report 21506199 ↗
• MalfunctionJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CUSTOMER SUFFERED BURNS DURING THE USE OF AN ELECTROSURGICAL DEVICE IN A PROCEDURE. A NEW GENERATOR WAS USED WITH THE SAME HANDPIECE AND IT WORKED SUCCESSFULLY.

  Patient problems: Burn(s)

  MAUDE report 21240616 ↗
• MalfunctionJan 3, 2025Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING THORACOSCOPIC PARTIAL LUNG RESECTION PROCEDURE, THE RADIOFREQUENCY ELECTROSURGICAL GENERATOR FAILED TO OUTPUT COAGULATION AND COULD NOT STOP BLEEDING IN TIME. REPLACED WITH ANOTHER RADIOFREQUENCY ELECTROSURGICAL GENERATOR TO COMPLETE THE HEMOSTASIS OPERATION. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21064960 ↗
• MalfunctionDec 9, 2024Image Display Error/Artifact; Self-Activation or Keying; Device Displays Incorrect Message; Image Display Error/Artifact; Self-Activation or Keying; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS SELF-CHECKED NORMALLY. WHEN USING THE UNIT TO CUT TISSUE FOR THE PATIENT, THE UNIT¿S SCREEN SUDDENLY BEGAN TO FLASH, HAD AN ALARM CODE AND COULD NOT WORK PROPERLY. AFTER THE UNIT WAS TURNED ON, RELEASING THE FOOT PEDAL OR RELEASING THE HAND KNIFE COULD NOT STOP THE UNIT, SO THE UNIT WAS IN A CONTINUOUS ACTIVATION STATE AND THE UNIT ENTERED AN ALARM. THE UNIT WAS RESTARTED BUT COULD NOT BE RESTORED TO NORMAL COMPLETELY. THE NURSE IMMEDIATELY REPLACED THE SPARE E LECTROSURGICAL GENERATOR TO CONTINUE THE SURGERY, RESULTING IN A DELAY IN THE SURGERY TIME. THE PATIENT WAS IN AN OPEN CAVITY STATE, BUT SURGERY HAD BEEN COMPLETED WITHOUT CAUSING FURTHER IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20883890 ↗
• MalfunctionNov 27, 2024Fire; Fire

  ACCORDING TO THE REPORTER, DURING USE, THE ELECTROCOAGULATION WIRE CONNECTED TO THE ELECTROCOAGULATION HOOK CAUGHT FIRE WITH A "POP" SOUND, AND SOON THE ELECTROCOAGULATION WIRE WAS BURNED OFF. THE OPERATOR HURRIED TO PUT OUT THE FIRE.

  Patient problems: Insufficient Information

  MAUDE report 20800712 ↗
• MalfunctionNov 19, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY UNDER GENERAL ANESTHESIA, THE INSULATION LAYER OF THE COMPETITOR'S ELECT ROSURGICAL PEN WAS DAMAGED. WHEN THE SURGEON WAS USING A GENERATOR TO DETACH THE TISSUE, THE SURGEON SUDDENLY FELT A TINGLING SENSATION IN HAND. IMMEDIATELY CHECKED AND FOUND THAT THE SHELL OF THE ELECTRODE WIRE HAND-HELD PART WAS DAMAGED. THE EXPOSED IRON FIBERS PIERCED THE SURGEON'S GLOVES, CAUSING MINOR NEEDLE-LIKE SLIGHT BURNS TO THE SURGEON'S HANDS WHEN THE GENERATOR WAS ACTIVATED. THE E LECTROSURGICAL PEN WITH A NEW ONE WAS REPLACED IMMEDIATELY. THE SURGEON APPLIED MEDICINE TO THE BURNED AND TREATED THE WOUND. THE FACILITY REPLACED THE ELECTROSURGICAL PEN WITH A NEW ONE TO RESOLVE THE ISSUE.

  Patient problems: Burn(s); Paresthesia

  MAUDE report 20723781 ↗
• MalfunctionNov 4, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE UNIT'S RETURN ELECTRODE MONITORING (REM) WAS ABNORMAL AND REM SIGNAL REMAIN GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604065 ↗
• MalfunctionOct 29, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD A REM TEST FAILURE AND THAT THE REM SIGNAL REMAINED GREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563610 ↗
• MalfunctionOct 21, 2024Communication or Transmission Problem; Inappropriate or Unexpected Reset; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Inappropriate or Unexpected Reset; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PARTIAL SMALL INTESTINAL RESECTION, THE UNIT FAILED AND RESTARTED, CAUSING THE RADIATION TO FAIL TO WORK AND RESTART SWITCH WAS DAMAGED. AFTER THE DISPOSAL MEASURE OF REPLACING THE EQUIPMENT, THE SURGERY WAS COMPLETED. THE PROCEDURE WAS PROLONGED FOR 15 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20494167 ↗
• MalfunctionSep 23, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S REM MONITORING HAD ABNORMALITY. THE REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278298 ↗
• MalfunctionSep 17, 2024Break; Inaccurate Delivery; Communication or Transmission Problem; Break; Inaccurate Delivery; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE UNIT'S FRONT INDICATOR LIGHTS DOES NOT LIGHT UP AND THERE WAS A BROKEN ACCESSORY CONNECTOR ON THE MAIN PCB (PRINTED CIRCUIT BOARD) ALSO LOCATED AT THE FRONT UNDERNEATH THE KEYPAD. THE PAD INDICATOR LIGHT GOES GREEN WITHOUT PAD. THE CUT AND COAGULATION INDICATOR LIGHTS SOMETIMES STUCK AT 119 AND 999. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242399 ↗
• MalfunctionSep 9, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S REM REMAINED GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20174962 ↗
• MalfunctionAug 28, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD AN ANOMALY ALARM FOR THE NEGATIVE BOARD INTERFACE. THE REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089502 ↗
• MalfunctionAug 9, 2024Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AN ELECTROSURGICAL GENERATOR WAS USED. THE HOST CAUGHT FIRE, CAUSING THE MAINBOARD TO BURN OUT, AFFECTING THE SURGICAL PROCESS AND THE SAFETY OF THE PERSONNEL DURING THE OPERATION. THE PROBLEMATIC EQUIPMENT WAS DEACTIVATED AND AN EMERGENCY ALTERNATIVE WAS SELECTED TO REPLACE IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949526 ↗
• MalfunctionAug 6, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD REM FAILURE. THE REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. THEY USE A NEW GENERATOR WITH THE SAME HANDPIECE AND IT WORKED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921531 ↗