ForceTriad FT6009Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884524002903), received between Jun 2, 2023 and Apr 23, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED THE OUTCOMES OF PATIENTS WHO UNDERWENT ROBOTIC DISTAL GASTRECTOMY WITH A SINGLE-PORT ROBOTIC PLATFORM FOR THE TREATMENT OF GASTRIC CANCER BETWEEN MARCH 2023 AND APRIL 2024. IT WAS NOTED THAT A LIGASURE DEVICE OR COMPETITOR PRODUCT WAS UTILIZED INTRA-OPERATIVELY TO DIVIDE THICK TISSUE AND VESSELS. THERE WERE 20 PATIENTS INCLUDED IN THE STUDY AND COMPLICATIONS INCLUDED PLEURAL EFFUSION AND CHYLE ASCITES. NO RE-OPERATION OR MORTALITY WAS REPORTED; HOWEVER, INTERVENTIONS AND PATIENT OUTCOMES ARE UNKNOWN.

  Patient problems: Ascites; Pleural Effusion

  MAUDE report 21893010 ↗
• MalfunctionApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PROCEDURE, PATIENT HAD A FIRST-DEGREE BURN ON THE BUTTOCKS WHICH ALSO SHOWED IN THE PHOTO.

  Patient problems: Burn(s)

  MAUDE report 21852930 ↗
• MalfunctionJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD A FIRST-DEGREE BURN AROUND THE RETURN ELECTRODE MONITORING PLATE (REM) ON THE RIGHT SIDE OF THE PATIENT AND IT WAS TREATED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19445161 ↗
• MalfunctionJan 29, 2024Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING PROCEDURE, ACTIVATION AND END TONE WERE HEARD BUT SEALING WAS INADEQUATE PARTIAL. BLEEDING WAS OBSERVED DIRECTLY FROM THE LIGASURE SEAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18602682 ↗
• MalfunctionDec 14, 2023Break; Inaccurate Delivery; Break; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING SERVICING, THE UNIT WAS CLEANED AND DISINFECTED ACCORDING TO MANUFACTURER¿S GUIDELINE. THE UNIT WAS RECEIVED IN GOOD VISUAL CONDITION. THE REM FUNCTION FAILED ON 1 OHM TEST, DRY SOLDER ON REM CONNECTOR AT STEERING RELAY PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) SIDE, CURRENT SOFTWARE VERSION: 4.00.03. THE REM CONNECTOR SOLDERING WAS REFLOWED ON STEERING RELAY PCBA. OUTPUTS TESTED IN ALL MODES OF OPERATION TEST: PASSED. REM-SYSTEM TEST: PASSED. HIGH FREQUENCY LEAKAGE TEST: PASSED. LOW FREQUENCY ELECTRICAL SAFETY TEST: PASSED. CROSS COUPLING TEST: PASSED. FUNCTIONAL TEST OF ALL HAND SWITCH PORTS, FOOTSWITCH CONNECTIONS AND TOUCHSCREEN TEST: PASSED. THE UNIT HAS BEEN TESTED SUCCESSFULLY AND WAS FULLY CHECKED FOR FUNCTIONALITY AND PATIENT ELECTRICAL SAFETY ACCORDING TO MANUFACTURER¿S GUIDELINES AND NORM. DEVICE WAS TECHNICALLY EFFICIENT AND SAFE TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327915 ↗
• MalfunctionJun 2, 2023Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING BIPOLAR HYSTEROSCOPY RESECTION, THE FOOTSWITCH STOPPED WORKING AND DOES NOT POWER UP, IT STOPPED THE PROCEDURE AND POSTPONED PATIENT WAS UNDER ANESTHESIA ALL THE TIME. THEY PERFORMED AROUND 10 TO 12 PROCEDURES WITH THE FOOTSWITCH. USED THE SAME GENERATOR WITH ANOTHER FOOTSWITCH AND IT WAS WORKING. THE PROCEDURE WAS RESCHEDULED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054731 ↗