Force Triverse FT3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884524000084), received between Aug 21, 2017 and Jul 17, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Fire” (9 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K051627, K150735); they may or may not involve this specific model.

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.

Recalls naming this device

1. Feb 15, 2019Terminated

   Potential for the sterile packaging to be compromised

   Z-1020-2019 · Root cause: Equipment maintenance · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC PROCEDURE, THE PATIENT WAS NOT HARMED BUT THE PHYSICIAN WAS BURNED (MINOR BURN) ON THE HAND.

  Patient problems: Burn(s)

  MAUDE report 22529976 ↗
• MalfunctionMay 26, 2025Fire; Fire

  IT WAS REPORTED THAT DURING A BELOW KNEE AMPUTATION PROCEDURE, THE DEVICE LIT UP, INDICATING A DEVICE FIRE. NO MEDICAL OR SURGICAL I INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF A FUNCTION, AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO INJURY REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084813 ↗
• MalfunctionApr 30, 2025Fire; Fire

  ACCORDING TO THE REPORTER, DURING A BELOW KNEE AMPUTATION PROCEDURE, THE TIP LIT UP LIKE A CANDLE. TIP WAS REPLACED AND THE PENCIL WORKED FINE. LATER THE SAME CASE, ANOTHER PENCIL WAS USED AND THE TIP SPARKED AND BURNED LIKE CANDLE AGAIN. THEY USED NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO OPERATING ROOM FIRE AND IT EXTINGUISHED ON ITS OWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935244 ↗
• MalfunctionApr 30, 2025Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, DURING A BELOW KNEE AMPUTATION PROCEDURE, THE TIP LIT UP LIKE A CANDLE. TIP WAS REPLACED AND THE PENCIL WORKED FINE. LATER THE SAME CASE, ANOTHER PENCIL WAS USED AND THE TIP SPARKED AND BURNED LIKE CANDLE AGAIN. THEY USED NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO OPERATING ROOM FIRE AND IT EXTINGUISHED ON ITS OWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935196 ↗
• MalfunctionApr 11, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A LAPAROSOPIC PROCEDURE, IT WASN'T POSSIBLE TO SET UP THE AMPERAGE MANUALLY, THREE INSTRUMENTS HAD TO BE USED IN ONE OPERATION. THE FIRST DEVICE HAD SELF ACTIVATION. THERE WAS NO ACTIVATION ON THE 2ND DEVICE. THE SURGEON USED BOTH HAND SWITCH AND FOOT SWITCH. THE 3RD PENCIL WAS USED AND IT WORKED FINE. THERE WAS NO BURN INCIDENT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16714149 ↗
• MalfunctionMar 7, 2023Fire; Fire

  ACCORDING TO THE REPORTER, DURING A LIVER RESECTION, THE SURGEON WAS USING THE BOVIE, IT WAS SET DOWN. WHEN THEY WENT TO PICK IT UP AGAIN , THERE WAS A FLAME AT THE BOVIE TIP.

  Patient problems: Insufficient Information

  MAUDE report 16499317 ↗
• MalfunctionAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE ARE SEVERAL ACCOUNTS OF WHAT POTENTIALLY HAPPENED. THE SURGEON STATED THEY BELIEVED IT WAS A SPARK COMING FROM THE DEVICE. THE REM PAD PLACEMENT AND FAULTY FORCE TRIVERSE PENCIL COULD BE THE CAUSE. THE STAFF BELIEVES THE NORMAL PROTOCOLS FOR REM PAD PLACEMENT AND ENERGY SETTINGS WERE CORRECT. THEY BELIEVED THAT THE PENCIL WAS NOT PROPERLY HOLSTERED IN THE PROVIDED PLASTIC HOLSTER AND ITS POSSIBLE THAT DURING THE CASE AN THE BUTTON WAS INADVERTENTLY ACTIVATED BY THE PLACEMENT OF THE RETRACT OR SURGEONS ELBOW. THEY MANUALLY CHECKED THE GENERATOR ERROR AND EVENT LOGS AND THERE WAS NO EVIDENCE OF AN ERROR. THE PATIENT HAD SMALL FIRST DEGREE BURN TO EPIDERMIS TO THE RIGHT SIDE UPPER ABDOMEN NEAR NAVAL AND WAS TREATED WITH OINTMENT AND BANDAGE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15306320 ↗
• MalfunctionAug 2, 2022Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD AN INTERMITTENT ACTIVATION. WHEN THE DEFECTIVE PRODUCT WAS CONNECTED TO THE GENERATOR, THE CUT BECAME A STATUS THAT IT WAS CONTINUED TO OUTPUT ALL THE TIME. THE GENERATOR WAS DISCONNECTED AND CONNECTED AGAIN, BUT THE SITUATION DID NOT IMPROVE, SO A NEW FT3000 WAS TAKEN OUT AND THE OPERATION WAS STARTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15148270 ↗
• MalfunctionDec 10, 2021Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY LIVER RESECTION, THE POWER CONTROL ACTIVATED EVEN THOUGH IT WAS NOT TOUCHED. USED A NEW PENCIL AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976380 ↗
• MalfunctionApr 16, 2021Energy Output Problem; Device Remains Activated; Energy Output Problem; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD AN ACTIVATION ISSUE, THE ACTIVATION BUTTON STICK IN THE 'ON' POSITION. THE DOCTOR WAS UNABLE TO MANUALLY CHANGE THE POWER OF THE DEVICE PEN. AT THE END OF THE SURGERY, THE SAME PEN WAS TESTED ON ANOTHER GENERATOR, BUT IT WAS ALSO NOT ABLE TO CHANGE THE ENERGY POWER MANUALLY. THE DOCTOR ONLY MANAGED TO CHANGE THE POWER OF THE ENERGY IN THE GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678170 ↗
• MalfunctionOct 28, 2020Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A LEAD WAS BEING TESTED WHEN THERE WAS A FLAME THAT STARTED IN THE POCKET WHEN THE DEVICE WAS BEING USED. IT WAS ALSO NOTED THAT THERE WAS AN ARC CREATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10745863 ↗
• MalfunctionSep 17, 2020Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE ACTIVATED EVEN THE BUTTON WAS NOT BEING PRESSED. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10550327 ↗
• MalfunctionAug 19, 2020Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A BILATERAL BREAST REVISION WITH PLACEMENT OF IMPLANTS AND LIPOSUCTION, THE SURGEON JUMPED BACK AND A SPARK WAS OBSERVED. THE SURGEON WAS BURNED ABOVE THE WRIST THROUGH GOWN AT THE TIME THE INSTRUMENT WAS USED INSIDE THE CAPSULE, BREAST AREA. THE SCREEN SETTINGS WERE MONOPOLAR 2 RECEPTACLE, 25 CUT, 30 COAGULATION AND LEVEL 3. A NEW PEN WAS USED WITH NO RECURRENCE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 10427432 ↗
• MalfunctionMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL ABDOMINAL HYSTERECTOMY, WHILE PERFORMING HEMOSTASIS OF THE PERITONEAL AND MUSCULAR LAYERS. THE GAUZE NEAR THE BODY SPARKED AND HAD SMOLDERING COMBUSTION. WHEN FIRE WAS SMOLDERING AT THE OPERATION FIELD, GAUZE WAS IMMEDIATELY REMOVED AND DROPPED ON THE FLOOR, AND FIRE WAS PUT OUT. IT COULD NOT BE SPECIFIED HOW BIG THE FIRE WAS. AN ISOZINE, A DISINFECTANT, WAS FOUND TO BE ADHERED TO THE GAUZE. FT3000 WAS REPLACED AND SAME FT10 WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10038135 ↗
• MalfunctionMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN APRIL 2014 AND JUNE 2016 POST-OPERATIVE COMPLICATIONS OF WOUND HEALING DISORDERS OCCURRED IN A TOTAL OF 19 PATIENTS (33%), INCLUDING FAT NECROSIS AND INFECTIONS; HOWEVER THESE RATES WERE COMPARABLE BETWEEN GROUPS: 7 EP, 4 PEAK, 3 HS AND 5 APC, P=0.496. SEROMA OCCURRED IN 7 PATIENTS, WITH COMPARABLE NUMBERS BETWEEN GROUPS (P-VALUE NOT PROVIDED); THE HIGHEST NUMBER OF SEROMAS OCCURRED WITH THE USE OF HS (3), FOLLOWED BY 2 EP, AND IN 1 PEAK AND 1 APC PATIENT. HEMATOMAS OCCURRED IN 4 TOTAL PATIENTS: 3 EP AND 1 HS.

  Patient problems: Seroma

  MAUDE report 9819579 ↗
• MalfunctionAug 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE COATING ON THE TIP OF THE DEVICE CAME OFF WHILE IT WAS BEING USED. NOTHING FELL INTO THE PATIENT'S CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8928052 ↗
• MalfunctionAug 1, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING RIGHT BREAST LUMPECTOMY WITH AXILLARY NODE DISSECTION PROCEDURE, THE PENCIL'S ELECTRODE CAUGHT ON FIRE DURING ACTIVATION. THE SURGEON WAIVED THE DEVICE AND THE FLAME EXTINGUISHED. THEY OPENED ANOTHER DEVICE AND COMPLETED THE CASE. THERE WAS NO ISSUE ON THE GENERATOR AND NO PATIENT INJURY NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851516 ↗
• MalfunctionApr 24, 2019Loose or Intermittent Connection; Detachment of Device or Device Component; Loose or Intermittent Connection; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROXIMAL PANCREATICODUODENECTOMY, THE DEVICE WAS INSTALLED FROM THE BEGINNING, BUT THE SET-IN WAS LOOSE AND THE ELECTRODE CAME OFF IMMEDIATELY. NOTHING FELL INTO THE PATIENT'S CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546311 ↗
• MalfunctionDec 28, 2018Fire; Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DOCTOR WAS USING THE DEVICE AND A FLAME CAME OUT OF THE PENCIL TIP. THEY CHANGED THE TIP AND IT HAPPENED AGAIN. THEY OPENED A NEW DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8204199 ↗
• MalfunctionSep 11, 2018Fire; Device Remains Activated; Arcing; Fire; Device Remains Activated; Arcing

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS SPARKING AND SHOOTING FLAMES LIKE MATCH SIZE WHEN TURNED ON. MOREOVER, WHEN IT WAS SHUT OFF IT CONTINUED TO DO THE SAME. CORD OF THE DEVICE WAS CUT TO EXTINGUISH THE FLAME. REPLACED WITH SIMILAR DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7864133 ↗
• MalfunctionJul 24, 2018Fire

  ACCORDING TO THE REPORTER, DURING A OPEN FLAP, WHEN THEY WERE USING THE PENCIL, AFTER A FEW COAGULATION ACTIVATIONS, THE ELECTRODE TIP HAD A FLAME AND NOT A SPARK. THE FLAME WAS SAID TO BE A LITTLE LARGER THAN A QUARTER IN SIZE. THE FLAME WAS STOPPED WHEN THE PENCIL WAS DEACTIVATED. ANOTHER PENCIL WAS USED AND IT DID THE SAME THING ON THE FIRST ACTIVATION. THE SECOND PENCIL WAS TRIED ON A NEW GENERATOR AND THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7715308 ↗
• MalfunctionJun 29, 2018Fire; Fire

  ACCORDING TO THE REPORTER, DURING NEPHRECTOMY, THE ELECTRODE TIP CAUGHT FIRE LIKE A MATCH AND THE FIRE WAS PUT OUT TO CONTINUE THE PROCEDURE. THE ELECTRODE TIP WAS COVERED WITH INSULATION TUBE DURING USE. THE GENERATOR SETTING WAS 30W MOST OF THE TIME. THE SURGEON'S GLOVE BURNT BUT THERE WAS NO INJURY. ALSO NO PATIENT HARM. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7650272 ↗
• MalfunctionJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PRIOR THE PROCEDURE, THE DEVICE WAS CONNECTED TO GENERATOR BUT THE GENERATOR DISPLAY WAS NON RESPONSIVE INDICATING THE DEVICE WAS NOT RECOGNIZED. THE DEVICE WAS DISCONNECTED FROM THE GENERATOR AND CONNECTED REPEATEDLY FOR A FEW TIMES, BUT THE ISSUE WAS NOT SOLVED. WHILE DISCONNECTING AND CONNECTING THE DEVICE TO THE GENERATOR, THE CLINICAL ENGINEER'S HAND WAS IN CONTACT WITH THE CONNECTION TERMINAL OF THE HANDPIECE AND THE HAND GOT BURNT BECAUSE OF AN ELECTRIC SHOCK.

  Patient problems: Burn(s)

  MAUDE report 7645434 ↗
• MalfunctionJun 28, 2018Inappropriate/Inadequate Shock/Stimulation; Connection Problem; Inappropriate/Inadequate Shock/Stimulation; Connection Problem

  ACCORDING TO THE REPORTER, PRIOR THE PROCEDURE, THE DEVICE WAS CONNECTED TO A GENERATOR BUT THE GENERATOR DISPLAY WAS NON RESPONSIVE INDICATING THE DEVICE WAS NOT RECOGNIZED. THE DEVICE WAS DISCONNECTED FROM THE GENERATOR AND CONNECTED REPEATEDLY FOR A FEW TIMES, BUT THE ISSUE WAS NOT SOLVED. WHILE DISCONNECTING AND CONNECTING THE DEVICE TO THE GENERATOR, THE CLINICAL ENGINEER'S HAND WAS IN CONTACT WITH THE CONNECTION TERMINAL OF THE HANDPIECE AND THE HAND GOT BURNT BECAUSE OF AN ELECTRIC SHOCK.

  Patient problems: Burn(s)

  MAUDE report 7645422 ↗
• MalfunctionApr 20, 2018Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO A LAPAROSCOPIC PARTIAL NEPHRECTOMY, THE DEVICE WAS ACTIVATING ALTHOUGH THE ACTIVATION BUTTON WAS NOT BEING PRESSED AT THAT TIME. A NEW FT3000 WAS OPENED AND IT WORKED FINE. FOOT SWITCH WAS NOT BEING STEPPED ON AT THAT TIME OF ISSUE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7447320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051627, K150735. One submission often covers many models, so check the product and lot details in each record.

• Z-1446-2020 · Feb 10, 2020 · Terminated
  Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934