ForceTriad FT0022WRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521062099), received between Nov 1, 2021 and Oct 25, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL EVALUATED THE TRANSFER OF STRAY ENERGY DURING LAPAROSCOPIC VS. ROBOTIC TRANSABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA REPAIR BETWEEN 2019 AND 2022. IT WAS NOTED THAT MONOPOLAR ENERGY WAS DELIVERED BY A FORCE TRIAD. A MONOPOLAR SCISSOR WAS USED TO DELIVER ENERGY AT 30W COAGULATION FOR ALL CASES. AT COMPLETION OF THE PROCEDURE, SKIN BIOPSIES WERE TAKEN FROM ALL THE PORT SITES. A PICRO-SIRIUS RED STAIN WAS UTILIZED TO IDENTIFY THERMAL INJURY BY A BLINDED PATHOLOGIST. HOWEVER, NO CLINICAL MANIFESTATIONS WERE NOTED.

  Patient problems: Pain; Seroma

  MAUDE report 18005732 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A STUDY EVALUATED OUTCOMES OF PATIENTS WHO UNDERWENT TRANSVAGINAL SPECIMEN EXTRACTION AFTER LAPAROSCOPIC GASTRECTOMY FOR TUMORS BETWEEN NOVEMBER 2014 AND NOVEMBER 2018. THE LIGASURE DEVICE OR A COMPETITOR DEVICE WAS USED TO DIVIDE THE OMENTUM. THE DUODENUM WAS TRANSECTED WITH AN ENDOGIA (60 MM). IF TOTAL OR SUBTOTAL GASTRECTOMY, A 60MM STAPLER WAS USED TO DIVIDE THE ESOPHAGUS OR STOMACH WAS DIVIDED WITH 60 MM ENDOSCOPIC STAPLERS. THERE WERE 24 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED: DUODENAL STUMP LEAK AND BLEEDING. LEAK WAS TREATED BY TOTAL PARENTERAL NUTRITION. TREATMENT FOR BLEEDING INCLUDED BLOOD TRANSFUSION AND ONE PATIENT REQUIRED ENDOSCOPIC INTERVENTION AND REOPERATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15132088 ↗
• MalfunctionApr 19, 2022Fire; Melted; Fire; Melted

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGIC HYSTEROSCOPY PROCEDURE, THE CABLE CAUGHT FIRE AND MELTED DURING THE INTERVENTION. THERE WAS NO PATIENT INJURY BUT THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141927 ↗
• MalfunctionNov 1, 2021Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SEAL WAS NOT PROPERLY COMPLETED FROM THE BEGINNING OF USE. NO BLEEDING AFTER PROCEDURE. THERE WAS A REGRASP ALARM AND END TONE WAS UNKNOWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728677 ↗