Voyant Open Fusion Device EB240Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00607915138455), received between Feb 18, 2020 and Aug 18, 2026 — classified as 11 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (16 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, 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 ↗
• MalfunctionOct 3, 2023Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: WHIPPLE. EVENT DESCRIPTION: "SURGEON FEEDBACK FOR TRANSECTION TRIGGER IS A BIT HARD. EASY TO UNINTENTIONALLY PRESS THE ACTIVATE BUTTON DURING MANIPULATION." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 19SEP2023 FROM TERRITORY MANAGER" THE SURGEON SAID THE BLADE LEVER REQUIRED MORE FORCE TO ACTIVATE COMPARING TO [COMPETITOR DEVICE]. SO, HE JUST APPLIED MORE FORCE. THIS ISSUE WAS OBSERVED WITHIN THE FIRST CASE. THE DEVICE WAS ACTIVATED AROUND 3 TIMES BEFORE THE EXPERIENCE OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 25SEP2023 FROM TERRITORY MANAGER: THE DATE THE FEEDBACK WAS ORIGINALLY COLLECTED WAS ON THE DATE OF THE EVENT, 29AUG2023, NOT 30MAY2023. PRODUCT NOT AVAILABLE FOR RETURN TYPE OF INTERVENTION: "YES". PATIENT STATUS: NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865768 ↗
• MalfunctionApr 7, 2023Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: GENERATOR BUTTONS ARE STICKING. TYPE OF INTERVENTION: NI PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704504 ↗
• InjuryMar 30, 2023Self-Activation or Keying; Mechanical Jam; Self-Activation or Keying; Mechanical Jam

  PROCEDURE PERFORMED: SIGMOIDECTOMY. EVENT DESCRIPTION: THE SURGEON RECEIVED A "CHECK STUCK BUTTON" ERROR WHEN THE DEVICE WAS INITIALLY PLUGGED IN. THE ALARM WAS CLEARED, AND THE SURGEON PROCEEDED WITH THE CASE. THE DEVICE WAS WORKING FINE FOR 16 ACTIVATIONS. ON THE 17TH ACTIVATION, THE JAWS WOULD NOT OPEN WHEN THEY WERE SEALING ON THE MESENTERY OF THE RECTAL WALL. THE DEVICE WOULD NOT UNLATCH AGAIN WHEN THE SURGEON WAS SEALING A SMALL BUNDLE ON THE 18TH ACTIVATION. THE DEVICE MADE NOISES THAT INDICATED THAT THE DEVICE WAS UNLATCHING BUT THE JAWS WERE UNRESPONSIVE TO THE HANDLE MECHANISM. NO AUDIBLE NOISE OR VISUAL DAMAGE TO THE DEVICE WAS OBSERVED PRIOR TO THE EXPERIENCE. IT IS UNKNOWN IF THE BLADE LEVER WAS NOT RETURNING TO THE FORWARD POSITION WHEN RELEASED. NO BLEEDING OCCURRED. THE SURGEON STITCHED AROUND THE DEVICE AND CUT THE DEVICE TO THE REMOVE IT FROM THE PATIENT. NO PATIENT INJURY OCCURRED AS A RESULT OF THE EVENT. TYPE OF INTERVENTION: THE SURGEON STITCHED AROUND THE DEVICE AND CUT THE DEVICE TO REMOVE IT FROM THE PATIENT. PATIENT STATUS: NO PATIENT INJURY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16649877 ↗
• InjuryJan 9, 2023Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: PROSTATECTOMY. EVENT DESCRIPTION: DURING A PROSTATECTOMY, TO ACHIEVE HEMOSTASIS DISSECTION BETWEEN THE PROSTATE AND THE PLEXUS OF SANTORINI, THE SURGEON USED THE VOYANT. THIS ONE COAGULATED BUT DID NOT LOOSEN THE JAWS ANYMORE. CURRENT CONDITION OF THE PATIENT: THE PROSTATE WAS INJURED, TORN ON THE ANTERIOR SURFACE. ACTIONS TAKEN IN THE HEALTH CARE FACILITY TO MANAGE THE PATIENT: IMMEDIATELY CHANGED THE INSTRUMENT AND CHECK HEMOSTASIS AND SURROUNDING ORGANS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 2JAN23: INDICATION FOR THE SURGERY WAS PROSTATECTOMY FOR ADENOCARCINOMA IT WAS A FULL PROSTATECTOMY + LYMPH NODES. THE MANIFESTATION OF THE INJURY LEAD TO EXTENDED OPERATING TIME, NO ADDITIONAL DIAGNOSTICS OR MEDICAL/MEDICINAL TREATMENT, NO ADMISSION TO ICU OR EXTENDED HOSPITALIZATION. DIFFICULT TO EXPLAIN ADDITIONAL SURGICAL TREATMENT, BUT THE ANASTOMOSIS FOR THE URETER WAS PROCEED DIFFERENTLY AND MAY OCCUR LEAKS. NOTHING NOTIFY FOR THE MOMENT ABOUT UPDATED PATIENT STATUS. THE DEVICE WAS REMOVED BY CUTTING AROUND THE JAW WITH A SCALPEL. THERE WAS TISSUE BLEEDING AS A RESULT FROM DEVICE REMOVAL. THE BLEEDING WAS CORRECTED WITH A M

  Patient problems: Rupture

  MAUDE report 16123629 ↗
• MalfunctionNov 21, 2022Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: OPEN COLOSTOMY TAKEDOWN. EVENT DESCRIPTION: THE SURGEON WAS ATTEMPTING TO SEAL TISSUE AND THE JAWS GOT STUCK TO THE TISSUE. WHEN THEY ATTEMPTED TO REMOVE THE JAWS, IT RIPPED THE TISSUE AND CAUSED EXTRA BLEEDING. THE SURGEON COMPLETED THE SURGERY USING LAPAROSCOPIC DEVICES AND SUTURING. THE BLEEDING WAS OBSERVED FROM A SPECIFIC VESSEL SEAL. ADDITIONAL INFORMATION CANNOT BE PROVIDED. THE REP WAS NOT PRESENT FOR THE CASE. PATIENT IS FINE. TYPE OF INTERVENTION: THE SURGEON COMPLETED THE SURGERY USING LAPAROSCOPIC DEVICES AND SUTURING. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15840565 ↗
• MalfunctionNov 19, 2022Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: LOW ANTERIOR RESECTION (LAR). EVENT DESCRIPTION: THE REP WAS PRESENT FOR THE CASE, AND IT WAS AN OPEN CASE USED WITH AN ALEXIS. ON THE VERY FIRST ACTIVATION THE DEVICE DID NOT SEAL. THE JAWS CLAMPED BOTH SIDES WITH IMA IN BETWEEN. THE GENERATOR BEEPED A NUMBER OF TIMES DURING THE SEAL CYCLE AND THE END TONES WERE HEARD BUT IT TOOK LONGER THAN USUAL TO COMPLETE THE SEAL CYCLE. THE DEVICE DID NOT SEAL AT ALL. THE VESSEL WAS CUT AND TIED WITH SUTURES. THE DEVICE WAS NOT USED FOR SOME TIME AS THE SURGEON WAS TEACHING HOW TO CUT & TIE WITH SUTURES. LATER IN THE CASE, THE DEVICE WAS USED AGAIN AND FOR THE SECOND AND THIRD ACTIVATIONS IT WORKED FINE. THEY COMPLETED THE CASE WITH THE SAME DEVICE. THERE WAS NO ADVERSE PATIENT INJURY. THE PRODUCT WILL NOT RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 10NOV2022 FROM [VOYANT PROJECT MANAGER, APPLIED MEDICAL]: "NO ALARMS SOUNDED". THE BLADE WAS ACTIVATED AFTER HEARING THE END TONE. YES, BLEEDING WAS EXPERIENCED AFTER ACTIVATING THE BLADE. THE PATIENT DID NOT EXHIBIT ANY VASCULAR PATHOLOGY, NOR WAS THE DEVICE ACTIVATED ON DISEASED OR INFLAMED TISSUE. ZERO TISSUE EFFECTS WERE OBSERVED AT THE SEAL SITE. TYPE OF INTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15830541 ↗
• MalfunctionNov 11, 2022Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: COLOSTOMY CLOSURE & SECUM SMALL BOWEL RESECTION. EVENT DESCRIPTION: THIS WAS AN OPEN CASE THAT THE REP WAS PRESENT FOR. THERE WAS A TOTAL OF 22 ACTIVATIONS. ON THE 18TH ACTIVATION, WHILE ON THE ILEOCOLIC ARTERY, WITH THE DEVICE ABOUT "75-80%" FULL, INSUFFICIENT HEMOSTASIS WAS EXPERIENCED. THE SURGEON ATTEMPTED TO ACTIVATE THE DEVICE ON THE TISSUE AND VESSEL AGAIN, BUT THE PROBLEM PERSISTED FOR 4 ADDITIONAL ACTIVATIONS AND THE BLEEDING WAS STILL UNCONTROLLED. WHILE A NEW EB240 WAS BEING UNPACKAGED TO BE SWAPPED WITH THE PROBLEMATIC EB240, THE SURGEON CUT AND TIED THE OPEN LUMEN WITH SUTURES AND THE BLEEDING WAS CONTROLLED. NO PATIENT INJURY OCCURRED. THE DEVICE WAS CLEANED 9 TIMES THROUGHOUT THE CASE. NO IMPROVEMENT WAS NOTED AFTER CLEANING THE JAWS, POST INSUFFICIENT HEMOSTASIS. THE NEW EB240 WAS USED ONLY ON "AVASCULAR PLANES". AS THE CASE CONTINUED, OOZING WAS NOTICED FROM PREVIOUS SEAL SITES AND THE NEW EB240 WAS USED TO RESEAL THOSE AREAS. THE SURGEON NOTED THAT THIS ADDED "SIGNIFICANT TIME" TO THE CASE. THE CASE TOOK APPROXIMATELY 6 HOURS. THE PATIENT WAS DIAGNOSED WITH DIVERTICULITIS AND HAD A RECENT SIGMOIDECTOMY. THE SURGEON HAD 1 ACCIDENTAL RELEASE EAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15784710 ↗
• MalfunctionNov 9, 2022Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: COLOSTOMY TAKEDOWN EVENT DESCRIPTION: "THIS IS THE FOURTH TIME I'VE USED OPEN FUSION AND HAD A MESENTERY BLEED. IT'S THE SAME THING EACH TIME. IN STANDARD TISSUE FOR PATIENT DISEASE STATE. NONE HAVE BEEN CROHN'S PATIENTS, MORBIDLY OBESE, ON BLOOD THINNERS, OR HAD CHALLENGING TISSUE OTHERWISE. AFTER ONE OR TWO ACTIVATIONS - THE DEVICE STOPS SEALING PROPERLY. YOU CAN SEE WHERE THE FAT FUSED BUT VESSELS DID NOT. THEY WEREN'T LARGE VESSELS (2-3MM MAX). THE DEVICE FEELS LIKE IT'S MADE "CHEAP", TOO EASY TO HIT THE ACTIVATION BUTTON, WHEN I CLOSE THE JAWS, IT FEELS TOO SMOOTH, LIKE IT'S NOT CLOSING DOWN WITH ENOUGH PRESSURE, AND IT HASN'T PERFORMED CONSISTENTLY FOR ME SINCE I AGREED TO TRIAL IT" WHEN ASKED IF BLEEDING WAS OBSERVED FROM A SPECIFIC VESSEL SEAL OR IF THERE WAS GENERAL OOZING OBSERVED AROUND THE SEAL AREA, THE RESPONSE WAS "THE MESENTERY FAT FUSED OK BUT THE VESSEL DIDN'T SEAL AT ALL. THERE ARE PHOTOS I SUBMITTED TO THE CD TEAM IN ADDITION TO THE DEVICE I SENT IN FOR TESTING. LEFT COLIC WAS THE VESSEL." THERE WAS NO TENSION APPLIED TO A VESSEL OR BUNDLE BEING SEALED. WHEN ASKED IF THERE WAS ESCHAR BUILDUP ON THE JAWS WHEN THE INSUFFICIENT HEMOSTASIS WAS O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15763864 ↗
• InjurySep 29, 2022Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: BELOW THE KNEE AMPUTATION. EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. ABOUT 3/4 OF THE WAY THROUGH THE CASE THE JAWS AND HANDLES GOT STUCK IN THE CLOSED POSITION WITH THE BLADE EXPOSED. IT WAS NOTED THAT THE SURGEON TOOK A BIGGER BITE OF TISSUE THAN WAS RECOMMENDED. TO REMOVE THE DEVICE, THE SURGEON CUT AROUND IT USING SUTURING AND TYING TO CONTROL ANY BLEEDING. THERE WAS NO ADDITIONAL TISSUE DAMAGE THAN WHAT WAS EXPECTED WITH A BKA. THE SURGEON DID TRY TO OPEN THE HANDLES OF THE DEVICE BUT WAS NOT ABLE TO SO THEY DECIDED TO CUT THE DEVICE OFF OF THE TISSUE. THE BLADE LEVER WAS NOT ABLE TO RETURN TO THE FORWARD POSITION. THERE WAS NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 27SEP2022 FROM ACCOUNT MANAGER ONCE THE VOYANT WAS REMOVED THE SURGEON COMPLETED THE CASE WITH A [MONOPOLAR DEVICE] THEN CUT AND TIE METHOD. TYPE OF INTERVENTION: CASE WAS COMPLETED WITH A [MONOPOLAR DEVICE] AND THEN CUT/TIE METHOD. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506681 ↗
• MalfunctionSep 29, 2022Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: OPEN COLECTOMY EVENT DESCRIPTION: VOYANT COMPLAINT OCCURRED. THE ISSUE, WHICH I WAS ABLE TO UNCOVER, IS THE POSITION OF THE ENERGY ACTIVATION BUTTON COMBINED WITH THE SENSITIVITY OF THE ENERGY ACTIVATION BUTTON. THE SURGEON HAS SHORT FINGERS WHICH REQUIRES HIM TO POSITION HIS HAND IN SUCH A WAY THAT IT MAKES ACCIDENTAL/UNINTENTIONAL CONTACT WITH THE ENERGY ACTIVATION BUTTON. PRODUCT IS NOT RETURNING. TYPE OF INTERVENTION: CASE WAS COMPLETED USING [COMPETITOR DEVICE]. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505734 ↗