Force EZ ForceEZ8CRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884521512085), received between Oct 12, 2017 and Jun 15, 2026 — classified as 3 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (17 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Self-Activation or Keying; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE UNIT WAS ABLE TO ACTIVATE AUTOMATICALLY EVEN THOUGH THE CIRCUIT HAD NOT BEEN COMPLETED AND THE GLOVE WAS FOUND TO BE BURNED. THIS RESULTED IN MILD BURNS TO THE HANDS OF THE PHYSICIAN. THE USE OF THE UNIT WAS IMMEDIATELY STOPPED AFTER DISCOVERY AND THE UNIT WAS REPLACED.

  Patient problems: Burn(s)

  MAUDE report 25504841 ↗
• InjuryNov 25, 2024Break; Inappropriate or Unexpected Reset; Appropriate Device Problem Term/Code Not Available; Break; Inappropriate or Unexpected Reset; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD FREQUENTLY AUTOMATIC RESTARTED. THE REPLACEMENT MAIN UNIT HAD COMPLETED THE SURGERY. PRELIMINARY ACTION WAS TO REPLACE THE POWER BOARD. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773219 ↗
• MalfunctionOct 21, 2024Self-Activation or Keying; Failure to Cut; Self-Activation or Keying; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE CUT FUNCTION CONTINUED TO BE ACTIVATED AUTOMATICALLY WHEN NO OPERATION WAS PERFORMED. IT WAS IMMEDIATELY DISCONTINUED AND ANOTHER DEVICE WAS REPLACED FOR USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494116 ↗
• MalfunctionOct 2, 2024Break; Image Display Error/Artifact; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Break; Image Display Error/Artifact; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY FOR PATIENT WITH MULTIPLE GALLSTONES AND CHOLECYSTITIS, THE UNIT SUDDENLY LOST POWER DURING USE, AND THE SCREEN HAD NO DISPLAY. AFTER CHECKING THE POWER CORD AND POWER INTERFACE, THERE WAS NO ABNORMALITY. THE PANEL WAS TURNED ON AND OFF AGAIN AND THE DISPLAY WAS RESTORED, BUT THE POWER OUTAGE OCCURRED AGAIN IN A SHORT TIME. STOPPED USING THE ELECTROSURGICAL GENERATOR IN THE OPERATING ROOM AND REPLACED IT WITH ANOTHER ELECTROSURGICAL GENERATOR TO CONTINUE THE SURGERY ON THE PATIENT. IT RESULTED IN PROLONGED SURGERY AND ANESTHESIA TIME.

  Patient problems: Insufficient Information

  MAUDE report 20350732 ↗
• MalfunctionAug 21, 2024Inaccurate Delivery; Failure to Align; Inaccurate Delivery; Failure to Align

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RETURN ELECTRODE MONITORING (REM) WAS ABNORMAL. IT REMAINED GREEN WHEN IT SHOULD NOT. ANOTHER DEVICE WAS USED WITH THE SAME ACCESSORIES AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011095 ↗
• MalfunctionAug 20, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RETURN ELECTRODE MONITORING (REM) REMAINED GREEN WHEN IT SHOULD NOT. ANOTHER DEVICE WAS USED WITH THE SAME ACCESSORIES AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20008752 ↗
• MalfunctionFeb 23, 2024Device Alarm System; Inaccurate Delivery; Failure to Align; Device Alarm System; Inaccurate Delivery; Failure to Align

  ACCORDING TO REPORTER, PRIOR TO USE, HAD REM ALARM ISSUE AND SIGNAL REMAINED GREEN EVEN IF ITS SHOULD NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18771100 ↗
• MalfunctionFeb 23, 2024Device Alarm System; Inaccurate Delivery; Failure to Align; Device Alarm System; Inaccurate Delivery; Failure to Align

  ACCORDING TO REPORTER, PRIOR TO USE, HAD REM ALARM ISSUE AND REMAINED GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769374 ↗
• MalfunctionFeb 22, 2024Failure to Deliver Energy; Connection Problem; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SELF-TEST OF THE UNIPOLAR GENERATOR BEFORE USE WAS NORMAL. THEN USING THE UNIPOLAR GENERATOR TO STOP BLEEDING, IT WAS FOUND THAT THE ELECTROSURGICAL HAND SWITCHING PENCIL HAD NO OUTPUT. THE PATIENT FAILED TO GET BLOOD COAGULATION AT THE FIRST TIME DURING THE OPERATION. AFTER REPLACING THE ELECTROSURGICAL HAND SWITCHING PENCIL WITH A NEW ONE, THERE WAS STILL NO OUTPUT. AFTER REPLACING THE GENERATOR MAIN UNIT, THE ELECTROSURGICAL HAND SWITCHING PENCIL COULD WORK NORMALLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18758706 ↗
• MalfunctionJan 18, 2024Energy Spectrum Incorrect; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Energy Spectrum Incorrect; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING USE, THE POWER WAS UNSTABLE AND OFTEN LOW, WHICH AFFECTED THE EFFECT OF SURGICAL TREATMENT. A FLASHING SCREEN APPEARED DURING THE USE OF THE ELECTROSURGICAL GENERATOR. RESTARTED AND RE-ADJUSTED THE POWER SO THAT IT COULD BE USED NORMALLY. HOWEVER, IT APPEARED MULTIPLE TIMES, IT HAD A SAFETY HAZARD AND STOPPED USING. THE POWER USED NEEDED TO BE ADJUSTED HIGHER THAN OTHER SIMILAR MODELS TO ACHIEVE THE SAME EFFECT.

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

  MAUDE report 18540256 ↗
• MalfunctionJan 10, 2024Device Alarm System; Inaccurate Delivery; Device Alarm System; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD REM ALARM. REM SIGNAL REMAIN GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484590 ↗
• MalfunctionNov 6, 2023Inaccurate Delivery; Failure to Align; Inaccurate Delivery; Failure to Align

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT'S REM HAD AN ABNORMAL CONDITION. THE REM SIGNAL REMAINED GREEN. RECONNECTED THE CABLE ,AND CALIBRATED THE FX GENERATOR, BY STEP4 -CHECKING AND ADJUST THE REM OSCILLATOR FREQUENCY AND IMPEDANCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075970 ↗
• MalfunctionSep 12, 2023Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S REM SIGNAL REMAINED GREEN WHEN IT SHOULD BE RED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732907 ↗
• MalfunctionSep 11, 2023Inaccurate Delivery; Inaccurate Delivery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720904 ↗
• MalfunctionAug 1, 2023Inaccurate Delivery; Inaccurate Delivery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431702 ↗
• MalfunctionJun 15, 2023Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UNIT REM WAS ABNORMAL. REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. ANOTHER GENERATOR WAS TESTED BY THE SAME ACCESSORIES AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134615 ↗
• MalfunctionMay 3, 2023Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD AN ABNORMAL REM ALARM, THE REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. ANOTHER GENERATOR WAS TESTED AND USED WITH THE SAME ACCESSORIES AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862057 ↗
• MalfunctionFeb 20, 2023Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S REM TEST FAILED AS THE REM SIGNAL STAYED GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404270 ↗
• MalfunctionJan 20, 2022Electrical Shorting; Electrical Shorting

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT WAS FOUND TO HAVE AN ABNORMAL HIGH-FREQUENCY LEAKAGE CURRENT. IN ORDER TO AVOID INJURY TO THE PATIENT, THE ENGINEER IMMEDIATELY DISASSEMBLED THE MACHINE AND FOUND THAT THE INTERNAL DUST WAS EXCESSIVE. DEALT WITH THE DUST IN TIME AND RESUMED NORMAL USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13302904 ↗
• MalfunctionJan 20, 2022Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S CUTTING WAS THE ISSUE, IT HAD AUTOMATIC CUTTING. ANOTHER GENERATOR WAS USED WITH THE SAME HANDPIECE AND IT WORKED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13300687 ↗
• MalfunctionSep 8, 2021Electrical Shorting; Electrical Shorting

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD LEAKAGE CURRENT DETECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440091 ↗
• MalfunctionSep 1, 2021Leak/Splash; Electrical Shorting; Leak/Splash; Electrical Shorting

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD CURRENT LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407181 ↗
• MalfunctionJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT WAS SCALDED WHEN THE UNIT WAS USED. PATIENT HAD 6CM BY 6CM BURN DEALT BY OINTMENT.

  Patient problems: Burn(s)

  MAUDE report 12235116 ↗
• MalfunctionMar 31, 2021Fire; Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RADICAL GASTRIC CANCER SURGERY, THE ELECTROCOAGULATION HOOK WAS FIRED, EXPLODED AND THE WIRE WAS BLOWN OFF WHEN USED FOR HEMOSTASIS. THE DEVICE WAS STOPPED AND REPLACED WITH OTHER HIGH-FREQUENCY DISSECTOR FOR SURGERY. THE EXPLOSION OF THE WIRE WAS IN THE GRIP OF SURGEON'S RIGHT HAND THAT CAUSED THE PHYSICIAN TO BE FRIGHTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600482 ↗
• MalfunctionDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THEY HAD TO TURN THE CLOTTING LEVEL OF THE UNIT HIGHER THAN USUAL TO GET ENOUGH ENERGY FOR THE PROCEDURE. AS A RESULT THE NON MEDTRONIC ELECTRODE WAS TOO HOT AND THIS LED TO THE SURGICAL FIELD AND THE PATIENT BEING BURNT. NO FLAMES WAS NOTED BUT SMOKED WAS SEEN. THERE WAS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 11088576 ↗