FORCE FX FORCEFXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10884524002613), received between Oct 13, 2017 and Jan 7, 2026 — classified as 8 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (18 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 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING THE PROCEDURE, THE DEVICE¿S TIP IGNITED (MATCH-SIZED FLAME) DURING USE. THE FLAME SELF-EXTINGUISHED AFTER ACTIVATION WAS STOPPED. NO OPERATING ROOM FIRE WAS REPORTED. FOLLOWING THE INITIAL INCIDENT, THE BIOMED DEPARTMENT CONDUCTED TESTING ON THE ESU AND IDENTIFIED HIGH-VOLTAGE ISSUES WITH THE GENERATOR. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990348 ↗
• MalfunctionOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A C-SECTION, THE FELLOW WAS USING THE BOVIE PENCIL AND WAS STARTING TO GO THROUGH THE PATIENT'S FASCIA WHILE THE SURGEON WAS HOLDING THE SKIN BACK. THE SURGEON WAS ON THE RIGHT SIDE OF THE PATIENT AS WELL AS THE GROUNDING PAD WHICH WAS PLACED ON THE RIGHT THIGH, AND THE GENERATOR WAS ALSO ON THE RIGHT SIDE. THE POWER ON THE FX WAS AT 35/35. THE SURGEON SAID THERE WAS A HOLE IN HER GLOVE AND SHE WAS DOUBLE GLOVED. THE SURGEON FELT HEAT AND A LITTLE JOLT. THE SURGEON FELT A PAIN THAT WENT UP HER RIGHT ARM AND ACROSS HER CHEST TO HER HEART. THE SURGEON REPORTED TO FEEL NOT RIGHT AND HER HEART STARTED TO RACE. THE SURGEON BACKED AWAY FROM THE TABLE AND THEY HAD TO CALL CODE BLUE, HOWEVER, THE SURGEON WAS ABLE TO AMBULATE OUT OF THE OPERATING ROOM INDEPENDENTLY, AND RESUSCITATION WAS NOT REQUIRED. A NEW GENERATOR AND BOVIE PENCIL WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT AND THE BABY WAS NOT HARMED/INJURED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Electric Shock; Tachycardia

  MAUDE report 23367536 ↗
• MalfunctionApr 7, 2025Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A COMPETITOR'S MONOPOLAR CORD ATTACHED TO A NON-MEDTRONIC LAP L-HOOK SPARKED AND CAUGHT THE DRAPE ON FIRE DURING A PROCEDURE. THE MONOPOLAR CORD BURNT OFF AND DETACHED FROM THE LAP L-HOOK END, ACCOMPANIED BY A LOUD POP AND SPARK. THE MONOPOLAR CORD WAS CONNECTED TO A FORCEFXC GENERATOR. THERE WAS NO INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785565 ↗
• MalfunctionJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TOTAL KNEE REPLACEMENT, THE PATIENT HAD SUFFERED BURNS ON THE SHOULDER AT THE PLATE ATTACHMENT AFTER USING THE GENERATOR EQUIPMENT.

  Patient problems: Burn(s)

  MAUDE report 21196720 ↗
• MalfunctionDec 27, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING DEMO, WHEN REM (RETURN ELECTRODE MONITORING) PAD WAS INSERTED IN RECEPTACLE LIGHT TURNED GREEN WHEN IT SHOULD REMAIN RED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21030149 ↗
• MalfunctionOct 2, 2024Inaccurate Delivery; Connection Problem; Inaccurate Delivery; Connection Problem

  ACCORDING TO REPORTER, DURING PREVENTIVE MAINTENANCE IN THE FACILITY, THE REM PORT WAS NOT ALARMING/LED TURNED GREEN. USING THE ANALYZER, THE REM CONNECTED EVERYTHING HOWEVER WAS NOT GETTING THE ALARM. IT WAS MENTIONED IT HAD THE REM CABLE BUT THE PLASTIC PIECE ON THE REM CABLE WAS NOT THERE. UNIT CAN USE REM WITH PIN AND WITH NO PIN HOWEVER WITH THE ONE WITH NO PIN, IT WILL ONLY ALARM WHEN 85% OF THE PAD WAS OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351858 ↗
• MalfunctionAug 26, 2024Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO REPORTER, DURING PROCEDURE, UNIT¿S BIPOLAR WAS USED AND BURN PATIENT.

  Patient problems: Burn(s)

  MAUDE report 20069807 ↗
• MalfunctionMay 22, 2024Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE STAFF PLUGGED IN A NON-MEDTRONIC SMOKE PENCIL INTO THE MONOPOLAR PORT ON THE FORCE FXC, THE PENCIL ACTIVATED WITHOUT IT BEING ACTIVATED BY THE SURGEON. THE SURGEON DID NOT HAVE THE PENCIL IN HIS OR HER HANDS. THE PENCIL WAS NEVER BEING USED ON THE PATIENT. THE STAFF GOT A DIFFERENT MEDTRONIC/COVIDIEN GENERATOR AND PROCEEDED WITH THE CASE WITHOUT AN ISSUE WITH THE PENCIL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372692 ↗
• MalfunctionApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO REPORTER, DURING USE, UNIT HAD AN INCIDENT REGARDING REM PADS CAUSING A BURN ON PATIENT¿S SKIN.

  Patient problems: Burn(s)

  MAUDE report 19169786 ↗
• MalfunctionJan 19, 2024Inaccurate Delivery; Failure to Align; Inaccurate Delivery; Failure to Align

  ACCORDING TO THE REPORTER, THE UNIT'S REM LIGHT DID NOT INDICATE GOOD CONTACT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544830 ↗
• MalfunctionOct 19, 2023Arcing; Appropriate Device Problem Term/Code Not Available; Arcing; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO REPORTER, DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE VIA LEFT FEMORAL ACCESS, THE DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO ADVANCE DUE TO ANGULATION OR KINKING IN THE AORTA. THE SYSTEM WAS WITHDRAWN FROM THE PATIENT, AND A DECISION WAS MADE TO ATTEMPT IMPLANT USING A SURGICAL LEFT SUBCLAVIAN APPROACH. THE INCISION WAS MADE USING AN ELECTRIC SCALPEL. SUBSEQUENTLY, THERE WAS A SPARK THAT CAUSED A SKIN BURN ON THE LATERAL SIDE OF THE LEFT HEMITHORAX AND THE INNER SIDE OF THE LEFT ARM. THE BURN WAS TREATED USING SALINE SOLUTION AND SILVER SULFADIAZINE. THE PROCEDURE WAS SUBSEQUENTLY ABORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE WOUNDS WERE HEALED WITH ANTIBIOTIC THERAPY. PATIENT WAS DISCHARGED FROM THE HOSPITAL.

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

  MAUDE report 17964964 ↗
• MalfunctionAug 31, 2023Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING PREVENTATIVE MAINTENANCE AT THE FACILITY, THE UNIT¿S REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT AND VICE VERSA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 17666942 ↗
• MalfunctionJul 18, 2023Inaccurate Delivery; Failure to Calibrate; Failure to Align; Inaccurate Delivery; Failure to Calibrate; Failure to Align

  ACCORDING TO THE REPORTER, THE UNIT DID NOT PASS THE HIGH REM QUEUE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND REM WAS FAILING THE HIGH TRIP POINT TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347357 ↗
• InjuryJul 18, 2023Adverse 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 LITERATURE, A PROSPECTIVE STUDY AIMED TO COMPARE THE OUTCOMES AFTER BIPOLAR ELECTROCAUTERY TONSILLECTOMY VERSUS COBLATION TONSILLECTOMY IN PEDIATRIC PATIENTS, AGE 3-12, BETWEEN FEBRUARY AND AUGUST 2022. A TOTAL OF 120 PATIENTS WERE RANDOMLY DIVIDED INTO TWO EQUAL GROUPS. SIXTY PATIENTS UNDERWENT COBLATION TONSILLECTOMY WITH A COMPETITOR DEVICE AND SIXTY PATIENTS UNDERWENT BIPOLAR ELECTROCAUTERY TONSILLECTOMY USING FORCE FX WITH STRAIGHT BIPOLAR FORCEPS WITH THE DEVICE SET AT 40 FOR BOTH DISSECTION AND CAUTERIZATION. ALL PATIENTS HAD THE PROCEDURE DONE UNDER GENERAL ANESTHESIA AND ORAL ENDOTRACHEAL INTUBATION. ACETAMINOPHEN AND IBUPROFEN WERE USED FOR PAIN CONTROL AND ANTIBIOTICS WERE GIVEN IN. ON THE LAST VISIT, THE OVERALL PAIN SCALE WAS SCORED OVER 40 REPRESENTED THE WORST PAIN SCALE (THE TOTAL NUMBER OF 4 VISITS). SIX PATIENTS IN THE BIPOLAR GROUP EXPERIENCED POSTOPERATIVE BLEEDING OR HEMORRHAGE. TWO PATIENTS BLED AFTER 24 H (REACTIONARY), TWO AFTER 48 H (REACTIONARY), ONE AFTER 4 DAYS (SECONDARY), AND ONE AFTER 1 WEEK (SECONDARY). ALL OF THEM WERE ADMITTED TO THE HOSPITAL, AND THE BLEEDING WAS CONTROLLED BY CONSERVATIVE METHODS. NONE OF THEM NEEDED REOPERATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 17345695 ↗
• MalfunctionMay 2, 2023Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT'S REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857519 ↗
• MalfunctionFeb 8, 2023Inaccurate Delivery; Failure to Calibrate; Inaccurate Delivery; Failure to Calibrate

  ACCORDING TO THE REPORTER, DURING TESTING, THE UNIT'S REM FUNCTION DID NOT FALL WITHIN THE MANUFACTURER SPECS AS PROVIDED IN THE SERVICE MANUAL. THE REM SIGNAL REMAINED GREEN WHEN INCREASING THE RESISTANCE FROM 120 OHMS AND UP AND REMAINED GREEN WHEN THE RESISTANCE DECREASED FROM 3 OHMS AND DOWN. THE REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT BE. AFTER CALIBRATING THE DEVICE AS PER MANUAL, THE REM DID NOT EXPERIENCE ANY IMPROVEMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323559 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS A ¿FLAMMATION¿ OCCURRED IN ONE EYE, LEAVING BURNS IN UPPER (2 INCHES INCLUDING LASHES) AND LOWER EYELIDS AND BURNING THE LASHES. THE PATIENT HAD A 1ST DEGREE BURN IN THE SKIN. THE PATIENT WAS TREATED BY APPLICATION OF COLD COMPRESSES EVERY 6 HOURS AND PAIN MEDICATION. THE PENCIL USED WAS A COMPETITORS DEVICE.

  Patient problems: Superficial (First Degree) Burn; Unspecified Tissue Injury

  MAUDE report 16067146 ↗
• MalfunctionDec 22, 2022Inaccurate Delivery; Failure to Align; Inaccurate Delivery; Failure to Align

  ACCORDING TO THE REPORTER, PRIOR TO USE, UNIT'S REM NOT PRODUCING CORRECT OUTPUT. REM SUPPOSED TO ALARM BETWEEN 135 +OR ¿ 5 OHMS BUT WHEN THE VALUE WAS RAISED FROM 120 OHM, IT DID NOT ALARM. WHEN BROUGHT THE RESISTANCE DOWN TO 60 OHMS IT SHOULD GO GREEN BUT IT DIDN¿T. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038163 ↗
• MalfunctionDec 8, 2022Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, UNIT WAS DEFECTIVE. THERE WAS UNKNOWN PATIENT INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15942500 ↗
• MalfunctionNov 14, 2022Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, THE REM WOULD NOT ALARM AT CORRECT RESISTANCE EVEN AFTER CALIBRATION. THE DEVICE REMAINED GREEN ALL THE WAY DOWN TO 1 OHM WHEN IT SHOULD ALARM AT 3 OHMS. A NEW/ANOTHER GENERATOR WAS USED WITH THE SAME ACCESSORIES AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789276 ↗
• MalfunctionNov 1, 2022Fire; Melted; Device Displays Incorrect Message; Connection Problem; Electromagnetic Compatibility Problem; Fire; Melted; Device Displays Incorrect Message; Connection Problem; Electromagnetic Compatibility Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD FIRE. IT WAS AT THE ENTRANCE WHERE THE MONOPOLAR 2 PEN WAS CONNECTED, WHEN YOU CONNECT THE TWEEZERS CABLE WITH THE HOOK WHEN TRYING TO USE THE EQUIPMENT THAT STARTED TO GIVE THE ERROR WHERE IT ENDED UP TAKING THE TWEEZERS CABLE AND REACHING THE SCALPEL ON THE 2 MONOPOLAR. THE PANEL WAS MELTED AS SHOWN IN THE PHOTO SUBMITTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712137 ↗
• MalfunctionOct 12, 2022Inaccurate Delivery; Material Deformation; Inaccurate Delivery; Material Deformation

  ACCORDING TO THE REPORTER, THE RETURN ELECTRODES ALARM (REM) DID NOT ILLUMINATE AND THE FRONT PANEL WAS DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 15587304 ↗
• MalfunctionJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AT THE END OF THE PROCEDURE, A BURN WAS DISCOVERED IN THE INFRAUMBILICAL OF THE PATIENT. THE DEGREE AND IF IT WAS TREATED WAS UNKNOWN.

  Patient problems: Burn(s)

  MAUDE report 14777729 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, BOVI CHANGED HEART RHYTHM FROM NORMAL TO TACH.

  Patient problems: Tachycardia

  MAUDE report 14569278 ↗
• MalfunctionApr 10, 2022Inappropriate/Inadequate Shock/Stimulation; Arcing; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE WHEN OPENING UP A POCKET FOR AN IMPLANT, THE UNIT HAD ARCING/SPARKING WHEREIN THE SCRUBS AND STERILE SCRUBS WAS BURNT AND HIT THE PHYSICIAN IN THE UPPER ABDOMEN. ALSO, THE UNIT SHOCKED THE PHYSICIAN AND HAD TO SIT DOWN AFTER THE SHOCK SINCE IT KNOCKED THE BREATH OUT OF DOCTOR AND HAD STAGGERED BACK AND NEEDED A FEW MOMENTS TO CATCH HIS BREATH.

  Patient problems: Electric Shock

  MAUDE report 14069414 ↗