Force FX Force FX-CS (UDI 10884524002620)Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10884524002620), received between Feb 15, 2018 and Oct 15, 2025 — classified as 12 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (10 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 89 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Failure to Calibrate; Failure to Align; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Failure to Align; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE TEMPLE BIOPSY, THE PATIENT WAS UNDER PARTIAL SEDATION. THE STAFF STARTED OFF WITH A CANNULA, THEN MOVED TO AN OXYGEN MASK. AFTER CHANGING TO THE MASK, THE DRAPE COVERING THE PATIENT, AS WELL AS THE MASK, CAUGHT ON FIRE. THE PATIENT WAS BURNT AND MASK THAT THE PATIENT WAS WEARING. THE DRAPE WAS THROWN TO THE FLOOR TO PREVENT ANY FURTHER INJURY. THE PATIENT WAS STABLE AFTER THE INCIDENT AND WAS CURRENTLY AT ANOTHER FACILITY RECOVERING FROM INJURIES SUSTAINED FROM THE BURNS. IT WAS PRESUMED THAT WHEN THE HANDPIECE WAS USED WITH THE OXYGEN MASK, IT MIGHT HAVE, CREATED AN OXYGEN RICH ENVIRONMENT, CAUSING THE FIRE. THE BIOMED PERFORMED OUTPUT TESTING USING TEST CABLES AND FOUND THAT ALL OUT FOR CUT, COAGULATION AND BIPOLAR WERE WITHIN SPECIFICATION. THE CUT WAS TESTED AT WATTAGE OF 75, COAGULATION AT A WATTAGE OF 30 AND BIPOLAR AT A WATTAGE OF 10. NO ISSUES FOUND. THE ONLY ISSUE BIOMED FOUND WAS DURING TESTING OF REM (RETURN ELECTRODE MONITOR) AT 135 OHMS--INSTEAD OF GETTING A VALUE OF 135 PLUS MINUS 5. THE BIOMED WAS GETTING A VALUE OF 143 OHMS WHICH IS 3 POINTS HIGHER THAN SPECIFICATION. THE PATIENT SUFFERED INJURIES FROM BURNS.

  Patient problems: Burn(s)

  MAUDE report 23292304 ↗
• MalfunctionJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BURN OCCURRED IN A PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22465184 ↗
• MalfunctionApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING SCALP LIPOMA EXERESIS SURGERY, THE ELECTRIC SCALPEL PEN HAD A TECHNICAL DEFECT (SPARKS), CAUSING SLIGHT BURN ON SCALP AND SOME HAIR STRANDS. THE NON-MEDTRONIC BRAND RETURN ELECTRODE PLATE WAS LOCATED AT THE BACK OF THE LEFT THIGH.

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

  MAUDE report 21858244 ↗
• MalfunctionJan 20, 2025Fire; Connection Problem; Fire; Connection Problem

  IT WAS REPORTED THAT THE UNIT'S MONOPOLAR 1 WAS TOAST-CABLE CAUGHT ON FIRE, AND THERE WAS A BURNT SIGNAL ON THE FRONT PART. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 21191009 ↗
• MalfunctionDec 13, 2024Self-Activation or Keying; Connection Problem; Self-Activation or Keying; Connection Problem

  ACCORDING TO THE REPORTER, CAUTERY TURNING OFF SHOOTING POWER; ACTIVATES THE COAG SPONTANEOUSLY. CUSTOMER EXPERIENCED THE ISSUE USING MULTIPLE PENS. CHECKED THE UNIT AND NO ERROR MESSAGE CAME UP WHEN TURNED ON. CHECKED THE KEYPADS AND FOOT PEDAL AND WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926555 ↗
• MalfunctionOct 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO REPORTER DURING USE, UNIT WAS USED IN AN ANIMAL CLINIC AND THE REM PAD WAS USED AT ITS LOWEST SETTING. PATIENT HAD 2 SMALL LESIONS ESU REM BURNS.

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

  MAUDE report 20380162 ↗
• MalfunctionOct 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO REPORTER DURING USE, UNIT WAS USED IN AN ANIMAL CLINIC AND THE REM PAD WAS USED AT ITS LOWEST SETTING. PATIENT HAD 2 SMALL LESIONS ESU REM BURNS.

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

  MAUDE report 20380137 ↗
• MalfunctionOct 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO REPORTER DURING USE, UNIT WAS USED IN AN ANIMAL CLINIC AND THE REM PAD WAS USED AT ITS LOWEST SETTING. PATIENT HAD 2 TO 6 INCHES LESIONS ESU REM BURNS.

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

  MAUDE report 20380135 ↗
• MalfunctionOct 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO REPORTER DURING USE, UNIT WAS USED IN AN ANIMAL CLINIC AND THE REM PAD WAS USED AT ITS LOWEST SETTING. PATIENT HAD 2 TO 6 INCHES LESIONS ESU REM BURNS.

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

  MAUDE report 20380079 ↗
• MalfunctionJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD A BURN. IN EVALUATING THE SUBSEQUENT DAYS, IMPROVEMENT WAS DETECTED IN THE PRIMARY LESIONS, THEREFORE NOT SHOWING INJURY CAUSED BY THE USE OF AN ELECTRIC SCALPEL.

  Patient problems: Burn(s)

  MAUDE report 19829665 ↗
• MalfunctionJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST RECONSTRUCTION WITH EXCHANGE OF TISSUE EXPANDERS FOR GEL IMPLANTS, PATIENT EXPERIENCED A BURN IN AN AREA NOT BEING CAUTERIZED. THE BURN APPEARED TO OCCUR BY ELECTRICAL CONDUCTIVITY THROUGH THE BASE OF WHERE THE TIP OF THE CAUTERY WAS CONNECTED TO THE HAND PIECE. SUPERFICIAL 2ND DEGREE BURN TREATED WITH TOPICAL OINTMENT. BACTRIACIN ZINC-POLYMYXIN B (POLYSPORIN) AND ANTIMICROBIAL WATER RESISTANT BANDAGE (MEPILEX) AND SURGICAL BRA WAS ALSO PLACED PER USUAL PROCEDURE. CUT/COAG SETTINGS WERE 30/30. CUSTOMER ALSO REPORTED THAT THE REMOVAL OF THE ELECTRODE HAS BEEN QUITE DIFFICULT. CUSTOMER EXCHANGED ELECTRODES OFTEN THROUGHOUT THE PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19626058 ↗
• MalfunctionJun 21, 2024Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST PROPHYLACTIC MASTECTOMY SKIN SPARING AND BILATERAL BREAST RECONSTRUCTION WITH TISSUE EXPANDERS AND BIOLOGIC MESH FOR SOFT TISSUE SUPPORT, DEVICE HAD ARCING/SPARKING ISSUE AND THE REMOVAL OF THE ELECTRODE HAS BEEN QUIET DIFFICULT. SURGEON EXCHANGE ELECTRODES OFTEN THROUGHOUT THE PROCEDURE. PATIENT EXPERIENCED A BURN ALONG THE INCISION DURING CAUTERY USE. THE BURN APPEARED TO OCCUR BY ELECTRICAL CONDUCTIVITY THROUGH THE BASE OF WHERE THE TIP OF THE CAUTERY WAS CONNECTED TO THE HAND PIECE. SURGEON NOTED BOVIE WAS NOT USED IN THAT AREA. AREA OF SKIN WAS REMOVED PER USUAL PROCEDURE NOT BECAUSE OF BURN. CUT/COAG SETTINGS WERE 40/40.

  Patient problems: Burn(s)

  MAUDE report 19584896 ↗
• MalfunctionJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST RECONSTRUCTION WITH EXCHANGE OF TISSUE EXPANDERS FOR GEL IMPLANTS, THE DEVICE HAD ARCING/SPARKING. THE STAFF REPORTED THAT WHEN THEY CHANGED OUT THE ELECTRODE FOR THE INSULATED TIP, THE ELECTRODE WAS EXTREMELY (AND UNUSUALLY) DIFFICULT TO REMOVE FROM BOVIE PENCIL. REMOVAL OF THE ELECTRODE HAS BEEN QUITE DIFFICULT. EXCHANGED ELECTRODES OFTEN TH ROUGHOUT THE PROCEDURE. THIS CAUSED PATIENT TO EXPERIENCE A BURN IN AN AREA NOT BEING CAUTERIZED. BURN APPEARED TO OCCUR BY ELECTRICAL CONDUCTIVITY THROUGH THE BASE OF WHERE THE TIP OF THE CAUTERY WAS CONNECTED TO THE HAND PIECE. SUPERFICIAL 2ND DEGREE BURN ON THE LEFT BREAST TREATED WITH TOPICAL OINTMENT. CUT/COAG SETTINGS WERE 40/40. BACITRACIN ZINC-POLYMYXIN B (POLYSPORIN) AND ANTIMICROBIAL WATER RESISTANT BANDAGE (MEPILEX) AND SURGICAL BRA ALSO PLACED PER USUAL PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19584499 ↗
• MalfunctionDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A BURN. PHOTO OBSERVATION NOTED THAT SKIN INJURY WAS CAUSED BY PRESSURE. THE INJURY WAS LOCATED ON THE INSIDE OF THE LEFT ARM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burn(s); Insufficient Information

  MAUDE report 18357044 ↗
• InjuryNov 27, 2023Failure to Deliver Energy; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Failure to Deliver Energy; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING TRANSURETHRAL RESECTION (TUR) OF THE BLADDER, WHILE USING NON-MEDTRONIC DEVICES, THE ENERGY DELIVERY OF THE UNIT STOPPED HALFWAY THROUGH THE PROCEDURE. BOTH THE RESECTOSCOPE AND THE GENERATOR ENERGY DEVICE WAS USED ONLY WITH THE DEVICE IN QUESTION AND COULD NOT TAKE AN ALTERNATIVE MEASURES, SO THE PROCEDURE WAS UNAVOIDABLY STOPPED. THERE WERE NO PROBLEMS UNTIL THE HALFWAY THROUGH THE PROCEDURE, SO IT WAS NOT A MISCONNECTION OR A MISTAKE IN THE ENERGY ACTIVATION SETTINGS. THE OPERATION WAS INTERRUPTED MIDWAY, SO A REPEAT SURGERY WAS REQUIRED. THE PATIENT WAS SCHEDULED FOR RE-SURGERY AND THE DATES WERE NOT KNOWN YET. THE PATIENT WAS UNDER ANESTHESIA WHEN THE PROCEDURE WAS ABORTED. IT WAS REPORTED THAT THE SURGERY WAS PERFORMED YESTERDAY WITH THE UNIT AND THAT THERE WAS NO PROBLEM WITH IT.

  Patient problems: Insufficient Information

  MAUDE report 18211726 ↗
• MalfunctionNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE UNIT WAS REPORTED WITH A PATIENT BURN.

  Patient problems: Burn(s)

  MAUDE report 18152246 ↗
• MalfunctionNov 13, 2023Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, UNIT ENCOUNTERED REM (RETURN ELECTRODE MONITORING) FAILURE. THE REM SIGNAL HAD REMAINED GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18127798 ↗
• MalfunctionOct 12, 2023Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD FAILED REM TEST. THE REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. OTHER UNITS WERE TESTED USING THE SAME CALIBRATORS AND THE OTHER UNIT PASSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17924985 ↗
• MalfunctionSep 26, 2023Inaccurate Delivery; Failure to Align; Inaccurate Delivery; Failure to Align

  ACCORDING TO THE REPORTER, THE UNIT'S REM FAILED. THE DEVICE WAS TURNING GREEN WHEN IT SHOULD¿VE BEEN RED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818426 ↗
• MalfunctionSep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING USE, THE EQUIPMENT WAS CAUSING HEMATOMAS ON PATIENT.

  Patient problems: Hematoma

  MAUDE report 17741890 ↗
• MalfunctionJul 19, 2023Failure to Deliver Energy; Inaccurate Delivery; Connection Problem; Failure to Deliver Energy; Inaccurate Delivery; Connection Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN CONNECTED TO OUR ESU (ELECTRO SURGICAL UNIT) ANALYZER, AND TESTED ACCORDING TO MEDTRONIC SERVICE MANUALS, THE MONOPOLAR 2 PORT DID NOT HAVE ANY OUTPUT AT ALL. MONOPOLAR 1 FUNCTIONED NORMALLY. THE REM STAYED GREEN UNTIL OVER 140OHMS, WHICH IS PAST WHAT IS STATED BY MEDTRONIC SERVICE MANUAL. THE REM LAMP STAYED GREEN WHEN IT SHOULD NOT. THEY USED ESU ANALYZER, AND MEDTRONIC SERVICE MANUAL. WE WERE ABLE TO REPLICATE STATED ISSUE AT WILL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17351411 ↗
• MalfunctionJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SURGEON HAD BURN.

  Patient problems: Burn(s)

  MAUDE report 17148925 ↗
• MalfunctionJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SURGEON HAD BURN.

  Patient problems: Burn(s)

  MAUDE report 17148923 ↗
• MalfunctionJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SURGEON HAD BURN.

  Patient problems: Burn(s)

  MAUDE report 17148914 ↗
• MalfunctionMay 5, 2023Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S REM FAILED AS IT'S SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. A NEW UNIT WAS USED WITH NO ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882249 ↗