Voyant Open Fusion DeviceRecalls & reported problems across all models

We found 2 models of Voyant Open Fusion Device by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Aug 18, 2026 — classified as 13 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Voyant Open Fusion Device problems

Voyant Open Fusion Device models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Voyant Open Fusion Device EB240

  Electrosurgical, Cutting & Coagulation & Accessories
  41 reports
• Voyant Open Fusion Device EB040

  Electrosurgical, Cutting & Coagulation & Accessories
  4 reports

Recent Voyant Open Fusion Device adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Mechanical Jam

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 50304566 ↗
• MalfunctionJul 27, 2026Excessive Heating

  Procedure Performed: Open Cystectomy + Small Bowel Obstruction. Event Description: "[Name]" (b)(6) was present as was attending cases in Adelaide helping out. The Gynecologist was sealing consecutively around an ovarian trying to mobilize it and then he placed it down on top of a drape and the plastic jaws burnt a hole through the sterile drape. No issue recorded as they continued using the device and it was sealing well. After the case the colorectal surgeon who was present was unhappy with the amount of thermal spread the device put out. No clinical impact to the patient. They continued using the device and didn't raise the situation as a fault but rather as the devices feature overall. Additional information received from "[Name]" (Snr Territory Manager) via email on 23July26: When the jaws burnt through the drapes, everyone in the room just contributed it consecutive sealing without letting the jaws cool down. In future when the device was put down it was then laid over a wet sponge to prevent it from happening again. Intervention: Continued on. Patient Status: Not affected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50010776 ↗
• MalfunctionApr 11, 2026Mechanical Jam

  PROCEDURE PERFORMED: ABDOMINOPLASTY. EVENT DESCRIPTION: DEVICE WAS USED FOR ABDOMINOPLASTY PROCEDURE. USER HAS BEEN USING FOR SEVERAL YEARS AND IT IS A COMMON PROCEDURE AT THIS ACCOUNT. NO KNOWN LOT OR SERIAL NUMBER DUE TO NOT REGISTERED DURING PROCEDURE AND PACKAGING THROWN AWAY. 2 EB240 DEVICES WERE USED DURING THE PROCEDURE AS DESCRIBED BELOW. THE OPERATION STARTED AND WENT SMOOTHLY UNTIL THE EXCESS WAS TO BE REMOVED, WHEN THE LEVER THAT DIVIDES THE TISSUE (BLADE LEVER & KNIFE) GOT STUCK AND COULD NOT BE MOVED. A NEW ONE (EB240 DEVICE) IS BROUGHT UP AND WE CONTINUE TO BURN AND CUT UNTIL THE SAME THING HAPPENS AGAIN. WE CAN OPEN THE JAWS NOW AND WE CONTINUE TO USE THE VOYANT TO ONLY SEAL VESSELS, NOT CUT. THE OPERATION IS COMPLETED WITHOUT ANY PROBLEMS. NOTED BY SURGEON AND OR NURSE WAS THAT THE PATIENT HAS A HARDER FAT LAYER AND MANY STRONG VESSELS. INTERVENTION: THEY BROUGHT OUT ANOTHER DEVICE AS DESCRIBED ABOVE. NEW DEVICE WORKED IN THE BEGINNING AND THEN THE SAME RESULT EXCEPT THAT WITH THE SECOND DEVICE THEY COULD REOPEN THE JAWS. THEY CONTINUED USING THE DEVICE AS A SEALING DEVICE ONLY WITHOUT CUTTING. PATIENT STATUS: NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851927 ↗
• MalfunctionFeb 20, 2026Mechanical Jam

  PROCEDURE PERFORMED: BREAST REDUCTION AND ABD PLASTIQUE. EVENT DESCRIPTION: 2 PRODUCTS LOCKED IN THE MIDDLE OF SURGERY, NOT POSSIBLE TO USE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 20NOV2025: LOT NUMBER UNKNOWN. THE JAWS WERE LOCKED IN BOTH CLOSED AND OPEN POSITION. NO AUDIBLE OR VISUAL DAMAGE NOTICED PRIOR TO THE EVENT. THE JAWS WERE UNRESPONSIVE WHEN THE SURGEON ACTUATED THE HANDLE LEVER. THE BLADE LEVER WAS NOT ABLE RETURN TO POSITION AUTOMATICALLY. THEY HAD TO USE A PLIERS IN ONE OF THE INCIDENT TO REMOVE THE DEVICE FROM THE TISSUE. NO TISSUE DAMAGE. NO TISSUE BLEEDING. INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: SUCCESSFUL PROCEDURES WITH NEW INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402120 ↗
• MalfunctionFeb 20, 2026Mechanical Jam

  PROCEDURE PERFORMED: BREAST REDUCTION AND ABD PLASTIQUE. EVENT DESCRIPTION: 2 PRODUCTS LOCKED IN THE MIDDLE OF SURGERY, NOT POSSIBLE TO USE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 20NOV25: LOT NUMBER UNKNOWN. THE JAWS WERE LOCKED IN BOTH CLOSED AND OPEN POSITION. NO AUDIBLE OR VISUAL DAMAGE NOTICED PRIOR TO THE EVENT. THE JAWS WERE UNRESPONSIVE WHEN THE SURGEON ACTUATED THE HANDLE LEVER. THE BLADE LEVER WAS NOT ABLE RETURN TO POSITION AUTOMATICALLY. THEY HAD TO USE A PLIERS IN ONE OF THE INCIDENTS TO REMOVE THE DEVICE FROM THE TISSUE. NO TISSUE DAMAGE. NO TISSUE BLEEDING. INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: SUCCESSFUL PROCEDURES WITH NEW INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401436 ↗
• MalfunctionOct 28, 2025Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: DURING A GYNECOLOGIC ONCOLOGY SURGERY, THE PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY UNDER GENERAL ANESTHESIA. ONCE THE INSERTION OF THE TROCAR BEGAN, AS DESCRIBED IN THE TECHNIQUE, THE ABDOMINAL WALL BECAME FIRM; HOWEVER, THE USUAL INSERTION CONTINUED WITH CONSIDERABLE DIFFICULTY. AFTER THE PERITONEUM WAS PENETRATED, THE OBTURATOR WAS REMOVED, AND A FRACTURE WAS OBSERVED. UPON INSERTING THE LAPAROSCOPE, THE TIP OF THE OBTURATOR WAS SEEN INSIDE THE CAVITY AND WAS IMMEDIATELY RETRIEVED. IMPACT: PROLONGED SURGICAL TIME AND INCREASED RISKS ASSOCIATED WITH THE PRESENCE OF THE OBTURATOR TIP INSIDE THE CAVITY. OUTCOME: RETRIEVAL OF THE OBTURATOR TIP FROM THE CAVITY. SAMPLE AVAILABLE: YES. PATIENT STATUS: PROLONGED SURGICAL TIME AND INCREASED RISKS ASSOCIATED WITH THE PRESENCE OF THE OBTURATOR TIP INSIDE THE CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405413 ↗
• MalfunctionJun 4, 2025Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: APRONECTOMY. EVENT DESCRIPTION: SEALING AND CUTTING ACROSS SUBCUTANEOUS FAT. AFTER TRANSECTING, THE TISSUE STARTED TO PART WITHIN THE JAWS BUT THE JAWS FAILED TO REOPEN AFTER RELEASING THE KNIFE ASSEMBLY AND HENCE COULD BE PULLED OFF THE TISSUE BUNDLE UNTIL THEY FORCED IT OFF AS THE KNIFE ASSEMBLY HADN'T RETRACTED. THERE IS NO CLINICAL IMPACT TO THE PATIENT. INTERVENTION: REPLACED THE DEVICE. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142404 ↗
• InjuryDec 5, 2024Excessive Heating; Excessive Heating

  PROCEDURE PERFORMED: PROCEDURE OPEN STRANGULATED FEMORAL HERNIA REPAIR AND SMALL BOWEL RESECTION. EVENT DESCRIPTION: ON (B)(6) 2024: [NAME REDACTED] (RSM) ADVISED VIA PHONE CALL THAT SHE WAS ADVISED THE COMPLAINT HAPPENED ¿A COUPLE OF WEEKS AGO¿, IT INVOLVED A BURN TO THE BOWEL DURING A COLORECTAL PROCEDURE. THE DEVICE MODEL IS UNKNOWN AT THIS STAGE. ON (B)(6) 2024: [NAME REDACTED] ADVISED THE FOLLOWING VIA EMAIL, AS NOTIFIED BY [NAME REDACTED], NURSE UNIT MANAGER: I HAVE LIMITED INFORMATION. PRODUCT NAME: VOYANT OPEN FUSION DEVICE WAS USED. WE DO NOT RECORD LOT NUMBERS FOR THESE DEVICES. PROCEDURE OPEN STRANGULATED FEMORAL HERNIA REPAIR AND SMALL BOWEL RESECTION DATE ON (B)(6) 2024. UNFORTUNATELY, I AM UNABLE TO PROVIDE A COPY OF THE VHIMS. THE PATIENT SUSTAINED AN IATROGENIC SKIN BURN ABOVE WOUND SITE 6CM X 2CM. THE BURN EVOLVED OF SUBSEQUENT DAYS REQUIRING X3 RETURNS TO THEATRE FOR DEBRIDEMENT AND EVENTUALLY CLOSURE. THE SAMPLE WILL NOT BE RETURNED AS IT WASN'T PLACED TO ONE SIDE. ON (B)(6) 2024: [NAME REDACTED] ADVISED BY PHONE THAT SHE BELIEVES, BASED ON COMMENTS FROM HER CONVERSATION WITH THE NUM THAT IT MAY BE USER ERROR: THE NUM ASKED WHETHER THE JAWS GET WARM. [NAME REDACT

  Patient problems: Bowel Burn; Burn(s)

  MAUDE report 20858666 ↗
• MalfunctionAug 26, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: OPEN HYSTERECTOMY. EVENT DESCRIPTION: THE DEVICE WAS BEING USED NORMALLY, ACTIVATION AND CUT. THE SURGEON WAS USING THE DEVICE NORMALLY BY COMPLAINING FROM THE DISSECTION. AT CERTAIN POINT, THE KNIFE WAS BROKEN, AND THE JAWS WERE NOT ABLE TO OPEN BUT FORTUNATELY OUTSIDE THE PATIENT. THE SURGEON TRIED SEVERAL TIMES TO OPEN AND CLOSES THE HANDLE AND THE KNIFE BUT NOT WORKING. NO CLINICAL IMPACT TYPE OF INTERVENTION: THE SURGEON CONTINUED THE CASE USING STANDARD BIPOLAR PATIENT STATUS: NO CLINICAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072240 ↗
• InjuryJul 22, 2024Temperature Problem; Temperature Problem

  PROCEDURE PERFORMED: HEMORRHOIDECTOMY. EVENT DESCRIPTION: [SURGEON NAME REDACTED] WAS PERFORMING A HEMORRHOIDECTOMY WITH EB240. THE PROCEDURE WAS FINISHED AND DEVICE THROWN AWAY. ONLY LATER THE PATIENT DISCOVERED TO HAVE 8CM THERMAL BURN LEADING TO PERFORATION. THIS HAPPENED OVER 6 WEEKS AGO AND THERE HAS BEEN AN INDEPENDENT INVESTIGATION. [NAME REDACTED] EXPLAINED THAT THEY NEED TO PROVE WHETHER THIS WAS USER ERROR OR DEVICE FAILURE. THE SCRUB NURSE HAS SAID THAT THERE WERE NO ERROR CODES. THE PATIENT HAD AN 8CM THERMAL BURN LEADING TO PERFORATION. THE PROCEDURE WAS FINISHED AND DEVICE THROWN AWAY. THE PATIENT RETUNED AND PRESENTED WITH THE SYMPTOMS. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 9JUL24: THE PATIENT REMAINS IN ITU CURRENTLY. INTERVENTION: THE PROCEDURE WAS FINISHED AND DEVICE THROWN AWAY. THE PATIENT RETUNED AND PRESENTED WITH THE SYMPTOMS. PATIENT STATUS: THE PATIENT HAD AN 8CM THERMAL BURN LEADING TO PERFORATION.

  Patient problems: Burn(s)

  MAUDE report 19797814 ↗
• MalfunctionJul 12, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: ABDOMINOPLASTY. EVENT DESCRIPTION: DIVIDING THE EXCESS SKIN AND FAT. THE INSTRUMENT PERFORMED WELL INITIALLY. AFTER ABOUT ONE HOUR THE KNIFE GOT STUCK AT THE OUTER PART OF THE JAWS. THEY TRIED TO ACTIVATE AND BURN POTENTIAL TISSUE STUCK BEHIND THE KNIFE AND ALSO FORCING THE BLADE LEVER TO COME BACK OUT BUT NOTHING WORKED. THEY SPENT ABOUT 15 MINUTES TRYING TO GET IT TO WORK. FINALLY, THEY DECIDED TO OPEN A NEW EB240 AND PROCEED. IT PERFORMED WELL AND THEY COULD FINISH THE SURGERY. TYPE OF INTERVENTION: REPLACED THE DEVICE AFTER SEVERAL ATTEMPTS TO GET RID OF THE TISSUE STUCK BEHIND THE KNIFE. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731424 ↗
• MalfunctionMay 10, 2024Failure to Deliver Energy; No Apparent Adverse Event; Failure to Deliver Energy; No Apparent Adverse Event

  PROCEDURE PERFORMED: OPEN CHOLECTOMY EVENT DESCRIPTION: TWO RELATED COMPLAINTS OCCURRED IN THE SAME PROCEDURE. COMPLAINT 1 OF 2: # (B)(4) COMPLAINT 2 OF 2: # (B)(4). THE REP WAS NOT PRESENT IN THE CASE. THE STAFF RELAYED TO THE REP THAT THE FUSE BUTTON WAS NOT WORKING AND THE DEVICE WAS NOT SEALING. NO ENERGY WAS BEING DELIVERED AND THE CASE WAS EXTREMELY BLOODY. THIS ISSUE WAS OBSERVED AT THE BEGINNING OF THE CASE, APPROXIMATELY 2-5 ACTIVATIONS INTO THE CASE. AFTER THIS EB240 ISSUE OCCURRED, A SECOND EB240 WAS OPENED BUT THE SAME ISSUE WITH THE FUSE BUTTON NOT WORKING OCCURRED AGAIN. THE CASE WAS COMPLETED WITH [COMPETITOR DEVICE]. THE TYPE OF TISSUE BEING GRASPED DURING THE EVENT IS UNKNOWN, BUT IT IS POSSIBLE THAT IT WAS MESENTARY TISSUE. THEY DID HEAR THE ACTIVATION TONE AND END TONE. IT IS UNKNOWN IF THERMAL EFFECTS WERE VISIBLE AT THE SITE. IT IS UNKNOWN IF THE BLADE WAS DEPLOYED DURING THE EVENT. THE PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: OPENED [COMPETITOR DEVICE] PATIENT STATUS: FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293540 ↗
• MalfunctionMay 10, 2024Failure to Deliver Energy; No Apparent Adverse Event; Failure to Deliver Energy; No Apparent Adverse Event

  PROCEDURE PERFORMED: OPEN CHOLECTOMY. EVENT DESCRIPTION: TWO RELATED COMPLAINTS OCCURRED IN THE SAME PROCEDURE. COMPLAINT 1 OF 2: (B)(4). COMPLAINT 2 OF 2: (B)(4). THE REP WAS NOT PRESENT IN THE CASE. THE STAFF RELAYED TO THE REP THAT THE FUSE BUTTON WAS NOT WORKING AND THE DEVICE WAS NOT SEALING. NO ENERGY WAS BEING DELIVERED AND THE CASE WAS EXTREMELY BLOODY. THIS ISSUE WAS OBSERVED AT THE BEGINNING OF THE CASE, APPROXIMATELY 2-5 ACTIVATIONS INTO THE CASE. AFTER THIS EB240 ISSUE OCCURRED, A SECOND EB240 WAS OPENED BUT THE SAME ISSUE WITH THE FUSE BUTTON NOT WORKING OCCURRED AGAIN. THE CASE WAS COMPLETED WITH [COMPETITOR DEVICE]. THE TYPE OF TISSUE BEING GRASPED DURING THE EVENT IS UNKNOWN, BUT IT IS POSSIBLE THAT IT WAS MESENTARY TISSUE. THEY DID HEAR THE ACTIVATION TONE AND END TONE. IT IS UNKNOWN IF THERMAL EFFECTS WERE VISIBLE AT THE SITE. IT IS UNKNOWN IF THE BLADE WAS DEPLOYED DURING THE EVENT. THE PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: OPENED [COMPETITOR DEVICE] PATIENT STATUS: FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288805 ↗
• MalfunctionMar 5, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY EVENT DESCRIPTION: WE HAD A DEFECTIVE DEVICE THIS MORNING IN SURGERY. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 28JUN2023 VIA EMAIL FROM ASSISTANT DIRECTOR OF SURGERY: THERE WAS NO PATIENT INJURY FROM THE DEFECTIVE DEVICE. THE SURGERY WAS COMPLETED BY OPENING AN ADDITIONAL VOYANT OPEN FUSION. IN TERMS OF MALFUNCTION, THIS DEVICE WOULD CLAMP DOWN AND WOULD NOT BURN. WAS ALSO STICKING AND DIFFICULT TO UNCLAMP. ADDITIONAL INFORMATION RECEIVED ON 29JUN2023 VIA EMAIL FROM ASSISTANT DIRECTOR OF SURGERY: THE DEVICE MALFUNCTIONED WHILE GRASPING FALLOPIAN TUBE ON THE FIRST ACTIVATION. THE ACTIVATION AND END TONES WERE HEARD, WITH THERMAL EFFECTS VISIBLE AT THE SEAL SITE. SOME MINOR BLEEDING AND OOZING WAS CAUSED WHEN TRYING TO OPEN THE JAWS, SINCE THE DEVICE HAD TO BE REMOVED WHILE STILL CLAMPED DOWN. TENSION WAS APPLIED TO THE VESSEL AND BUNDLE BEING SEALED. NO ESCHAR BUILT UP ON THE JAWS. THERE WERE NO GENERATOR ALARMS THAT INTERRUPTED THE SEAL CYCLE. THE DEVICE WAS NOT ACTIVATED ON DISEASED OR INFLAMED TISSUE. TYPE OF INTERVENTION: THE SURGERY WAS COMPLETED BY OPENING AN ADDIT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18841927 ↗
• MalfunctionOct 18, 2023Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: EXPLORATORY LAPAROTOMY AND COLOSTOMY REVISION. EVENT DESCRIPTION: SURGEON USED A SURGICAL RULER DURING THE OPEN CASE AND MENTIONED THAT HAVING CENTIMETER MARKINGS ON THE SHAFT OF VOYANT DEVICES COULD BE BENEFICIAL. THERE WERE ~4 ACCIDENTAL BUTTON PRESSES GIVING "CHECK DEVICE" ALARMS OUTSIDE THE PATIENT AS THE SURGEON WAS MOVING AROUND AND WOULD EASILY BUMP THE ACTIVATION BUTTON BUT SURGEON SAID THAT OVERALL OPEN FUSION DEVICE WORKED WELL IN THIS CASE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 12OCT2023 FROM APPLIED MEDICAL REPRESENTATIVE EVENT OCCURRED OUTSIDE THE PATIENT WHILE THE DEVICE WAS NOT NEEDED TO BE USED. OTHER DEVICES USED THROUGHOUT THE CASE WERE ENDO GIA STAPLER, METAL RETRACTOR, MONOPOLAR PENCIL, SURGICAL RULER. NO PATIENT INJURY. NO RESOLUTION WAS NEEDED. THE CASE WAS COMPLETED WITH THE SAME DEVICE. ~ 11 ACTIVATIONS HAD ALREADY OCCURRED ON TISSUE PRIOR. YES, THE DEVICE JAWS WERE CLEANED TWICE WITH GAUZE. TYPE OF INTERVENTION: NO RESOLUTION WAS NEEDED. THE CASE WAS COMPLETED WITH THE SAME DEVICE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961997 ↗

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