Force FX Force FX-8CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 10884524002590), received between Jun 12, 2017 and Mar 23, 2026 — classified as 5 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (13 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 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BURN.

  Patient problems: Burn(s)

  MAUDE report 24671586 ↗
• MalfunctionJul 10, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT THE UNIT WAS CUTTING WHEN IT WAS SUPPOSED TO BE COAGULATING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467436 ↗
• MalfunctionJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE UNIT NEEDED TO BE INSPECTED DUE TO PATIENT INJURIES.

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

  MAUDE report 21191841 ↗
• MalfunctionSep 18, 2024Failure to Calibrate; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD A GROUND/LEAKAGE/HIPOT FAILURE. THE PATIENT HAD SECOND DEGREE BURN ON THE LEFT SHOULDER BLADE. THE PATIENT RECEIVED TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20250304 ↗
• MalfunctionSep 9, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD REM FAILURE, THE DEVICE FAIL IN A WAY THAT WOULD ALLOW FOR DEVICE ACTIVATION WHEN IT SHOULD NOT OCCUR. IN OTHER WORDS, THE REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173445 ↗
• MalfunctionAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE ORTHOPEDIC PROCEDURE, THE PHYSICIAN FOUND A 10 CM LONG BURN MARK ON THE PATIENT'S BUTT WHERE THE PLATE WAS ATTACHED.

  Patient problems: Burn(s)

  MAUDE report 19905666 ↗
• MalfunctionJun 28, 2024Failure 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 ORTHOPEDIC SURGERY, THE GENERATOR SUDDENLY FAILED AND COULD NOT STOP THE BLEEDING IN TIME. THE INTRAOPERATIVE COAGULATION DID NOT WORK AND THE CONSUMABLES WERE REPLACED. THE USE WAS RESUMED AFTER RESTARTING. BLOOD TRANSFUSION WAS NOT NECESSARY. PATIENT WAS NOT ON ANY MEDICATIONS. CURRENTLY THERE ARE NO ISSUES ON THE PATIENT'S CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19639038 ↗
• MalfunctionApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A BURN.

  Patient problems: Burn(s)

  MAUDE report 19024176 ↗
• MalfunctionJan 1, 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.

  Patient problems: Burn(s)

  MAUDE report 18423122 ↗
• MalfunctionDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE PATIENT'S HAIR WAS BURNT.

  Patient problems: Burn(s)

  MAUDE report 18248373 ↗
• MalfunctionJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

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

  MAUDE report 17297606 ↗
• MalfunctionJun 6, 2023Adverse 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. CHECKED AND FOUND OUT THAT THE CAUTERY MACHINE WAS WORKING AND ALL OUTPUT PARAMETERS ARE WITHIN THE RANGES.

  Patient problems: Burn(s)

  MAUDE report 17075564 ↗
• MalfunctionMay 4, 2023Adverse 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.

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

  MAUDE report 16868142 ↗
• MalfunctionMay 3, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT WAS RUNNING AUTOMATICALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860303 ↗
• MalfunctionApr 14, 2023Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, THE UNIT GREEN REM INDICATOR LIGHT WAS ON EVEN IF THE REM ELECTRODE WAS NOT ATTACHED TO THE PATIENT AND SECOND WAS POSSIBLE INTERFERING WITH LAPARO TOWER DISPLAYS.

  Patient problems: Insufficient Information

  MAUDE report 16747134 ↗
• MalfunctionApr 14, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT AUTOMATICALLY RAN WITHOUT OPERATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743244 ↗
• MalfunctionMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THREE DAYS AFTER THE SURGERY, THE PATIENT HAD A 1ST DEGREE BURN ON FINGER AND WAS TREATED BY THE HOSPITAL STAFF. THE BURNING ISSUE WAS NOT CAUSED BY REM PAD OR HANDPIECE. PATIENT HAS RECOVERED. PHOTO WAS SUBMITTED SHOWING BLISTER ON PATIENT'S FINGER INDICATING SECOND DEGREE BURN.

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

  MAUDE report 16635782 ↗
• MalfunctionMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SURGEON HAD A HAND BURN. THE HAND PIECE AND REM PAD USED WERE A COMPETITOR'S DEVICE.

  Patient problems: Burn(s)

  MAUDE report 16622346 ↗
• MalfunctionOct 25, 2022Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, THE LEDS WERE GREEN EVEN WHEN THERE WAS NO PATIENT PLATE, THEY CHANGED THE CABLE BUT STILL GAVE THE ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670097 ↗
• MalfunctionJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD PALM-SIZED BURN.

  Patient problems: Burn(s)

  MAUDE report 15122346 ↗
• MalfunctionMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SURGEON RECEIVED A SMALL BURN.

  Patient problems: Burn(s)

  MAUDE report 14472101 ↗
• MalfunctionMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Burn(s)

  MAUDE report 14455693 ↗
• MalfunctionMay 16, 2022Device 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, THE UNIT HAD A BURNING ISSUE. UNIT DISPLAYED ERROR 18.

  Patient problems: Burn(s)

  MAUDE report 14408450 ↗
• MalfunctionMay 14, 2022Electromagnetic Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Electromagnetic Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A COLPOSCOPY PROCEDURE, THE UNIT WAS CUT OUT AND HAD A BURNING SMELL. IT WAS REPORTED THAT THEY WERE USING BLEND 50 AND FULGURATE 50 WHEN THE DEVICE TRIPPED AND ALL THE OTHER DEVICES IN THE ROOM WERE TURNED OFF. IT WAS ALSO REPORTED THAT THE DEPARTMENT RESET THE TRIP SWITCH ON THE MAIN SUPPLY. THERE WAS NO PATIENT INJURY BUT THE PROCEDURE WAS STOPPED AND RE SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403486 ↗
• MalfunctionMay 8, 2022Inaccurate Delivery; Failure to Align; Inaccurate Delivery; Failure to Align

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S REM LIGHT WAS NOT GREEN. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC INITIAL INVESTIGATION FOUND THAT THE REM INDICATOR WAS GETTING GREEN AUTOMATICALLY WITHOUT ATTACHING REM PADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14332556 ↗