ForceTriad FT0021SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20884521062082), received between Jun 7, 2016 and Feb 24, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN AN OLD BIPOLAR RESECTION CORD (LOT: X240X) WAS CONNECTED TO A NEWLY INSTALLED GENERATOR (SN: (B)(6)), IT DID NOT WORK/NON-COMPATIBILITY, ANOTHER FT0021S (LOT: Y180X) WAS USED FOR WHICH ALSO DID NOT WORK WITH THE VLFT10GEN (SN: (B)(6)) AND THREE OTHER VLFT10GEN. THE PATIENT WAS ALREADY UNDER ANESTHESIA, THE SURGEON HAD TO USE THE MONOPOLAR CUTTING LOOP CONNECTED TO THE MONOPOLAR CORD, INSTEAD OF USING THE BIPOLAR CUTTING LOOP ELECTRODE CONNECTED THE BIPOLAR CORD TO RESECT THE TUMOR. AFTER THE PROCEDURE, THE PATIENT WAS EXTUBATED AND TRANSFERRED TO PACU (POST-ANESTHESIA CARE UNIT) FOR RECOVERY FROM ANESTHESIA. AFTER RECOVERY, THE PATIENT WAS TRANSFERRED BACK TO HIS ROOM.

  Patient problems: Insufficient Information

  MAUDE report 24429550 ↗
• MalfunctionAug 8, 2024Fire; Material Integrity Problem; Fire; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD A CORD/CABLE ISSUE. DURING BIPOLAR PHOTOVAPORIZATION OF THE PROSTATE: BLACK SMOKE AND FLAME ON THE CONNECTORS OF THE BIPOLAR CABLE AND ON THE RESECTOR. SURGEON'S GOT BURNS.

  Patient problems: Burn(s)

  MAUDE report 19943124 ↗
• MalfunctionJun 27, 2024Electrical Shorting; Material Integrity Problem; Electrical Shorting; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THEY NOTICED AN ELECTRICAL LEAK; THERE WAS A SMALL CRACK ON THE PROXIMAL PORTION, ONE CONNECTED TO HANDPIECE CONNECTOR. PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19626921 ↗
• MalfunctionMay 6, 2024Overheating of Device; Inappropriate/Inadequate Shock/Stimulation; Arcing; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Inappropriate/Inadequate Shock/Stimulation; Arcing; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING CYSTODIATHERMY WITH ROLLERBALL VIA RESECTOSCOPE, THE DEVICE WAS WORKING AND THEN IT STOPPED. THE SURGEON EXPERIENCED ELECTRIC SHOCK WHEN THE DEVICE WAS USED. REATTACHED AND CHECKED ATTACHMENT AT MACHINE AND THE ROLLERBALL ATTACHMENT WAS CHECKED AND OK. THEY TRIED TO RE-USE ROLLERBALL, BUT WHITE SPARK AND HEAT CAME FROM CABLE. CABLE WAS CHECKED AND LOOKED FRAYED AT SITE OF INSERTION AT HANDPIECE, WIRES EXPOSED AND IN HALF - NEW - WAS NOT LIKE THIS AS PART OF CHECK. THE SURGEON WAS WEARING SURGICAL GLOVE AT TIME, BLACK DEBRIS AND BREAK IN GLOVE THAT CAUSED 1ST DEGREE BURN TO FINGER OF SURGEON. THE BURN WAS TREATED BY GIVING MEDICAL FIRST AID.

  Patient problems: Electric Shock; Superficial (First Degree) Burn

  MAUDE report 19248560 ↗
• MalfunctionJul 27, 2023Fire; Melted; Fire; Melted

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN CONNECTING THE CABLE TO THE UNIT, A SHORT CIRCUIT OCCURRED THAT CAUSED A DEVICE FIRE THAT BURNT/MELTED THE CORD/CABLE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402647 ↗
• MalfunctionJul 21, 2022Fire; Fire

  ACCORDING TO THE REPORTER, DURING A HYSTERO-RESECTION, THE UNIT'S CABLE CAUGHT FIRE AT THE CONNECTION WITH THE RESECTOSCOPE. THE DOCTOR ACTIVATED THE HANDLE VIA THE FOOT CONTROL; AND THE CABLE WAS SEVERED.

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

  MAUDE report 15074949 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE SURGEON PERFORATED THE PROSTATE WALL THAT CAUSED 250 TO 500 CC OF BLEEDING. THE SURGEON THEN NOTICED THAT THE DEVICE WAS DAMAGED, SAW A BURN, AT THE CONNECTION END OF THE HAND PIECE. NEW DEVICES (INSTRUMENTS) WERE OPENED DUE TO BURN DAMAGE ON THEM TO COMPLETE THE PROCEDURE, AND THERE WAS ONLY A SMALL AREA OF TISSUE DAMAGE/PERFORATION WITH BLEEDING NOTED ¿ WHICH WAS RESOLVED WITH CAUTERY.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8457455 ↗
• MalfunctionMar 2, 2019Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CABLE WAS BURNT BUT NO FLAME AT THE CONNECTOR THAT PLUGS INTO THE STORZ RESECTOSCOPE TO CONNECT TO OUR GENERATOR. ANOTHER CABLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384385 ↗
• InjuryNov 16, 2017Arcing; Flare or Flash; Adverse Event Without Identified Device or Use Problem; Arcing; Flare or Flash; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD AN ISSUE WITH THE LOOP. AFTER CONNECTING A RESECTOSCOPE, A BLAZING SOUND WAS HEARD FROM THE CABLE TIP DURING A SECOND ACTIVATION. SPARKING WAS ALSO NOTED. THE ISSUE RESULTED IN DAMAGE TO THE SURGEONS HAND AND A BURN TO THE TIP OF THE PATIENT'S URINARY OPENING. THE PATIENT EXPERIENCED BETWEEN 250-500 CC'S OF BLEEDING, REQUIRING A TRANSFUSION. THE PATIENT ALSO HAD A SECOND DEGREE BURN ON THE WALL OF THE SURGICAL SITE, REQUIRING ADDITIONAL SURGICAL TREATMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE ISSUE CAUSED PATIENT HOSPITALIZATION TO BE EXTENDED BY THREE ADDITIONAL DAYS.

  Patient problems: Blood Loss; Burn(s)

  MAUDE report 7036264 ↗
• MalfunctionJun 7, 2016Hole In Material; Arcing; Sparking; Arcing

  THE CUSTOMER REPORTED THAT WHEN THE PRODUCT WAS ACTIVATED, A SPARK WAS ACTIVATED OUT OF THE CABLE. THE PRODUCT WAS REVIEWED AND WAS FOUND DAMAGED, THE SURGEON CONTINUED THE SURGERY IN MONOPOLAR MODE. THE PATIENT WAS NOT INJURED. THIS CABLE WAS USED 8 TIMES . INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A SMALL HOLE ON THE SIDE OF THE CONNECTOR AT RESECTOSCOPE END AND THE DEVICE FAILED HIPOT TESTING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5705041 ↗