ForceTriadRecalls & reported problems

Summary

The FDA's MAUDE database contains 345 adverse event reports that list this exact device (DI 10884524001531), received between Mar 20, 2017 and Jun 29, 2026 — classified as 1 death, 21 injuries, 323 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (121 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 345 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Energy Output Problem; Self-Activation or Keying; Failure to Cut; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE UNIT STARTED CUTTING ON ITS OWN AND THEN AN ERROR MESSAGE ABOUT THE PEDAL APPEARED.

  Patient problems: Insufficient Information

  MAUDE report 25652219 ↗
• MalfunctionMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT GOT FIRST DEGREE BURN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24720916 ↗
• MalfunctionJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FIRST-DEGREE BURN AFTER THE PROCEDURE. A NON-MEDTRONIC REM PAD WAS USED ALONG WITH THE GENERATOR.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24091915 ↗
• MalfunctionNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING POSTERIOR CERVICAL LAMINOPLASTY, WHEN THE SURGEON WAS BEGINNING THE CASE, HE ACTIVATED THE BIPOLAR CAUTERY AND NOTICED SMOKE, A SPARK AND THEN A FLAME COME OUT OF THE BIPOLAR FORCEPS WHEN THE FOOTSWITCH WAS ACTIVATED. WHEN THE FOOTSWITCH WAS LET OFF THE ISSUE WAS RESOLVED. HE WAS HOLDING THE TIP IN THE AIR AND NOTHING ON THE SURGICAL FILED IGNITED. THE SURGEON WAS USING A NON-MEDTRONIC BIPOLAR FORCEPS. THE DISPOSABLE TUBING USED NON-MEDTRONIC AS WELL. THE MEDTRONIC GENERATOR WAS ON A SETTING OF 35. THE SERVICE COORDINATOR REMOVED THE GENERATOR, NON-MEDTRONIC BIPOLAR TIP, NON-MEDTRONIC BIPOLAR TUBING AND PACKAGING FROM SERVICE AND CONTACTED BIOMED. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643101 ↗
• MalfunctionAug 26, 2025Failure to Deliver Energy; Self-Activation or Keying; Failure to Deliver Energy; Self-Activation or Keying

  IT WAS REPORTED THAT DURING PROCEDURE; COAGULATION DID NOT STOP DESPITE THE CHANGING THE FOOT PEDAL AND HANDLE SCALPEL. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892537 ↗
• MalfunctionJun 27, 2025Failure to Calibrate; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD A LEAKAGE AND AN ERROR MESSAGE. THE PATIENT HAD FIRST DEGREE BURN THAT WAS CAUSED BY A NON-MEDTRONIC REM PAD.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 22350025 ↗
• MalfunctionJun 4, 2025Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE HANDPIECE HAD NO SEAL WHEN USED ON A NORMAL ARTERIOLE BETWEEN STOMACH AND SPLEEN. THERE WAS NO EVIDENCE OF ENERGY DELIVERY AND END TONES WERE HEARD. THERE WAS NO RE-GRASP ALERT OR ERROR. THE HANDPIECE WAS ABLE TO COMPLETE 3 GOOD SEALS BEFORE THE ISSUE OCCURRED AND WAS CLEANED NORMALLY. THE SURGERY WAS EXTENDED FOR 15 MINUTES AND BIPOLAR AND HEMOSTASIS WAS USED TO STOP ARTERIAL BLEEDING. BLOOD TRANSFUSION WAS NOT REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22143236 ↗
• MalfunctionMay 19, 2025Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A FACE GROWTH REMOVAL, THE DEVICE ACTIVATED SMALL FLAME AS SOON AS THE BUTTON WAS PRESSED. IT WAS EXTINGUISHED BY WATER. PHOTOS WERE SUBMITTED SHOWING DRAPE CAUGHT ON FIRE. THE PATIENT SUFFERED A MILD REDNESS AND SLIGHT BURN TO THE TIP OF THE NOSE AND THE BASED OF THE NOSTRILS (2 CM). DAILY MEDICATION WAS THE TREATMENT DONE TO THE PATIENT. THE PATIENT HAD BEEN DISCHARGED AND IS FINE.

  Patient problems: Burn(s)

  MAUDE report 22043682 ↗
• MalfunctionMay 5, 2025Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, THE HANDPIECE HAD NO COAGULATION. THE GENERATOR WAS CHANGED FROM FORCETRIAD TO LS10 BUT THE ISSUE WAS NOT RESOLVED. THE OPERATION TIME WAS EXTENDED FOR AT LEAST 5 TO 10 MINUTES. THE PATIENT HAD BLEEDING AND WAS RESOLVED BY USING BIPOLAR ENERGY. THE PATIENT WAS NOT TAKING ANY MEDICATIONS AND BLOOD TRANSFUSION WAS NOT NECESSARY. THE PATIENT IS DOING GOOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21960534 ↗
• MalfunctionMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER A TOTAL HYSTERECTOMY TO SEAL THE UTERINE ARTERY. POST-OPERATIVELY, PATIENT COMPLAINED OF ABDOMINAL PAIN, FEVER AND THE C-REACTIVE PROTEIN (CRP) LEVEL WAS HIGH, SO THE PATIENT WAS STILL ADVISED TO STAY IN THE HOSPITAL BUT WAS DISCHARGED AT THE PATIENT'S STRONG DESIRE. THE NIGHT AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT WAS TRANSPORTED IN EMERGENCY TO THE HOSPITAL DUE TO ABDOMINAL PAIN. IT WAS DISCOVERED THAT THE PATIENT HAD EXCESSIVE INTRAPERITONEAL HEMORRHAGE WITH NO PROXIMAL LIGATION FROM THE LOCATION WHERE THE UTERINE ARTERY WAS SEALED WITH LIGASURE. PATIENT WAS TREATED WITH HEMOSTASIS AND THE PATIENT'S LIFE WAS SAVED. THE SURGEON NOTED THAT BOTH LIGASURE AND TRIAD COULD BE USED WITHOUT ANY PROBLEMS DURING THE INITIAL CASE.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fever; Intra-Abdominal Hemorrhage

  MAUDE report 21695274 ↗
• MalfunctionMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT SUFFERED A SECOND DEGREE BURN. THE BURN WAS ABOUT 10 CM LONG IN THE HIP AREA AND WAS TREATED. THE NON-ORIGINAL ATTACHMENT AND NON-MEDTRONIC PATIENT PLATE WERE USED IN THE CASE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21676743 ↗
• MalfunctionFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE A NON-MEDTRONIC REM (RETURN ELECTRODE MONITORING) PAD OF THE UNIT HAD CAUSED AN UNKNOWN STAGE OF BURN TO THE PATIENT. AT THE BEGINNING OF THE PROCEDURE, ALERTS WERE RECEIVED INDICATING THAT THE ELECTRODE PAD WAS NOT PROPERLY ADHERED TO THE PATIENT. AFTER ATTEMPTING TO REAPPLY IT, THE PROCEDURE CONTINUED. IT WAS POSSIBLE THAT THE PAD DID NOT ADHERE PROPERLY DUE TO LOTION ON THE PATIENT'S SKIN. THE DEVICE WORKED FINE, ONLY THE REM PED HAD THE ISSUE.

  Patient problems: Burn(s)

  MAUDE report 21472989 ↗
• MalfunctionDec 10, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL GASTRECTOMY, AT THE BEGINNING, THE DEVICE WAS UNABLE TO COAGULATE THE MESENTERIC BLOOD VESSEL ALTHOUGH THE HARDWARE SCREEN SHOWED THE CIRCLE WAS COMPLETED. VESSEL THICKNESS WAS 2-3 MILLIMETERS. ENERGY DELIVERY WAS NOTED AND NO ERROR TONES WERE HEARD. TRIED SEVERAL TIMES TO CHANGE THE LOTS OF DEVICE, GENERATORS, AND EVEN POWER CHARGING LINES BUT THE EFFECT WAS THE SAME. THERE WAS A BLOOD LOSS OF 20 MILLILITERS; NO BLOOD TRANSFUSION WAS REQUIRED. THE JAWS WERE CLEAN AND FRESH, WITHOUT ESCHAR. THE PROCEDURE WAS NOT COMPLETED IN A VERY PLEASANT MOOD. THE GENERATOR HAS BEEN UPDATED TO SOFTWARE 4.0.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20892660 ↗
• MalfunctionDec 9, 2024Self-Activation or Keying; Connection Problem; Self-Activation or Keying; Connection Problem

  ACCORDING TO THE REPORTER, DURING SERVICING, THE UNIT HAD AUTOBIPOLAR ISSUE, WON'T TURN OFF AFTER ACTIVATION UNTIL THE INSTRUMENT WAS REMOVED. SCRAP DUE TO DEVICE END OF SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879661 ↗
• MalfunctionDec 5, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAP HEMICOLECTOMY, THE HANDPIECE HAD A SEALING INADEQUATE/PARTIAL WITH EVIDENCE OF ENERGY DELIVERY, END TONES HEARD AND NO RE-GRASP ALERT. BUT THERE WAS NO BLEEDING AFTER CUTTING WHEN USED WITH COLORECTAL ADHESIONS. THE TISSUE BEING SEALED WAS LESS THAN 7 MM AND HAD MORE THAN 10 GOOD SEALS BEFORE THE ISSUE OCCURRED. THE JAWS WERE CLEANED EVERY FEW MINUTES. THE DEVICE WAS CONNECTED TO THE GENERATOR. THE SURGEON CONTINUED TO USE IT DESPITE IT NOT SEALING WELL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855250 ↗
• MalfunctionSep 18, 2024Self-Activation or Keying; Connection Problem; Self-Activation or Keying; Connection Problem

  ACCORDING TO THE REPORTER, THE BIPOLAR SOCKET OF THE UNIT DID NOT STOP COAGULATING. IT CONTINUES TO COAGULATE EVEN IF THE BIPOLAR PEDAL WAS NO LONGER PRESSED.

  Patient problems: Insufficient Information

  MAUDE report 20250782 ↗
• MalfunctionSep 4, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A OPEN ESOPHAGECTOMY, THE SEALING WAS NOT GOOD IN DIFFERENT VESSELS AND THICKNESS. THERE WAS NO RE-GRASP ALERT BUT ACTIVATION TONE AND END TONE WERE HEARD. THE SURGEON NEEDED MORE SEALING CYCLES AND MORE CLIPS THAN USUAL FOR A GOOD RESULT. THE DEVICE WAS CLEANED 15 TIMES. PATIENT HAD OOZING/MINIMAL/MODERATE BLEEDING AROUND THE ESOPHAGUS AND STOMACH. THE PROCEDURE WAS EXTENDED FOR 30 MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20140088 ↗
• MalfunctionAug 22, 2024Computer Software Problem; Image Display Error/Artifact; Self-Activation or Keying; Computer Software Problem; Image Display Error/Artifact; Self-Activation or Keying

  ACCORDING TO THE REPORTER, THE UNIT AUTOMATICALLY TRIGGERED AND GOT HANG. THE TOUCHSCREEN WAS FROZEN. THIS HAPPENED AS SOON AS THE BIPOLAR MODE GOES TO SETTINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036070 ↗
• InjuryJul 12, 2024Device Alarm System; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER,5 TO 8 DAYS POST TONSILLECTOMY, PATIENT HAD MODERATE, CONTINUOUS BILATERAL AND DIFFUSE BLEEDING ABOUT 250 - 500 CC AT THE SITE OF THE SEALED DISSECTION. THE BLEEDING OCCURED IN VARIOUS AREAS AROUND THE SURGICAL SITE WHERE THE DEVICE WAS USED. BLOOD TRANSFUSION WAS NOT REQUIRED BUT IT WAS NECESSARY TO RE-OPERATE PATIENT FOR ADDITIONAL SUTURE. DURING THE REVISION SURGERY, SURGEON CLAIMED THAT THE SPECIFIC TISSUE AROUND THE SURGICAL SITE WAS ALREADY DAMAGED FROM THE DEVICE IN THE PREVIOUS SURGERY. PATIENT WAS TREATED BY SEALING TONSILLAR PILLARS AND WITH TACHOSIL PATCH. DURING THE ORIGINAL PROCEDURE, THERE WAS NO ACTIVATION TONE AND END TONE BUT THERE WERE INCOMPLETE CYCLE ERROR OCCURRED. PATIENT WAS NOT TAKING ANY MEDICATIONS PRIOR TO PROCEDURE AND DID NOT RECEIVED CHEMOTHERAPY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 19735916 ↗
• InjuryJul 12, 2024Device Alarm System; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER,7 TO 8 DAYS POST TONSILLECTOMY, PATIENT HAD MODERATE, CONTINUOUS BILATERAL AND DIFFUSE BLEEDING ABOUT 250 - 500 CC AT THE SITE OF THE SEALED DISSECTION. THE BLEEDING OCCURED IN VARIOUS AREAS AROUND THE SURGICAL SITE WHERE THE DEVICE WAS USED. BLOOD TRANSFUSION WAS NOT REQUIRED BUT IT WAS NECESSARY TO RE-OPERATE PATIENT FOR ADDITIONAL SUTURE. DURING THE REVISION SURGERY, SURGEON CLAIMED THAT THE SPECIFIC TISSUE AROUND THE SURGICAL SITE WAS ALREADY DAMAGED FROM THE DEVICE IN THE PREVIOUS SURGERY. PATIENT WAS TREATED BY SEALING TONSILLAR PILLARS AND WITH BIPOLAR ENERGY. DURING THE ORIGINAL PROCEDURE, THERE WAS NO ACTIVATION TONE AND END TONE BUT THERE WERE INCOMPLETE CYCLE ERROR OCCURRED. PATIENT WAS NOT TAKING ANY MEDICATIONS PRIOR TO PROCEDURE AND DID NOT RECEIVED CHEMOTHERAPY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 19735898 ↗
• DeathJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-TONSILLECTOMY PROCEDURE AND FROM AN ADDITIONAL INFORMATION, IT WAS FOUND OUT THAT THE SURGEON HAS USED THE BIZACT DEVICE FOR ABOUT SIX WEEKS. IN THAT TIME, HE HAD THREE BLEEDS. ONE WAS IMMEDIATELY POST-OP THAT HE STOPPED WITH CAUTERY, ONE WITH NO ADDITIONAL DETAIL, AND A PEDIATRIC PATIENT THAT RETURNED AFTER FIVE DAYS TO THE HOSPITAL WITH EXCESSIVE POST-OP BLEEDING AND EVENTUALLY PASSED AWAY DUE TO BLOOD LOSS. A FORCETRIAD WAS USED TOGETHER WITH THE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19721349 ↗
• MalfunctionJul 10, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE HAD A SEALING THAT WAS INADEQUATE OR PARTIAL (WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD). THE SEAL SHOWED EVIDENCE OF ENERGY DELIVERY, AND THERE WAS BLEEDING AFTER CUTTING. THE TISSUE OR VESSEL BEING SEALED WAS APPROXIMATELY THREE MM. THERE WAS NO ERROR MESSAGE. NO BLOOD TRANSFUSIONS WERE PERFORMED. THE COMPLETION OF THE PROCEDURE WAS DELAYED BUT IT WAS DONE BY SWITCHING TO ANOTHER GENERATOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 19711050 ↗
• MalfunctionJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PATIENT HAD FIRST DEGREE BURN APPROXIMATELY 10 CENTIMETERS IN LENGTH, LOCATED ON THE SIDE OF THE BACK, WHEN THE UNIT WAS USED. CREAM WAS RECOMMENDED FOR BURN TREATMENT. THE BURN WAS THOUGHT TO BE CAUSED BY THE REM PAD OR THE POVIDONE IODINE USED. THE REM PAD WAS NOT A MEDTRONIC PRODUCT. IT WAS ALSO REPORTED THAT THERE WAS A SIGNIFICANT ACCUMULATION OF POVIDONE IODINE IN THE BURNED AREA AND THAT THE SURGERY TOOK APPROXIMATELY 6 HOURS, SUGGESTING IT COULD BE POVIDONE IODINE-RELATED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19498201 ↗
• MalfunctionJun 3, 2024Failure to Align; Adverse Event Without Identified Device or Use Problem; Failure to Align; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE UNIT'S REM HAD A MALFUNCTION. THE PATIENT HAD A FIRST DEGREE BURN AROUND THE PATIENT PLATE/REM (ON THE RIGHT SIDE) AND WAS TREATED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19445141 ↗
• MalfunctionMay 28, 2024Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING SERVICING, OCCURRENCE OF THE REM TEST ALARM. UPPER AND MIDDLE REM ALARMS DID NOT OCCUR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404489 ↗