Voyant® Fine Fusion Device EB030Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00607915127428), received between Feb 24, 2016 and Sep 30, 2019 — classified as 1 death, 12 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Sticking” (39 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 87 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  PROCEDURE PERFORMED: LEFT THYROIDECTOMY. INCIDENT DESCRIPTION: THE REP WAS PRESENT FOR THE CASE. THE SURGEON WENT TO SEAL A LARGER VESSEL WHEN THE JAWS GOT STUCK. HE TRIED VARIOUS METHODS TO REMOVE THE JAWS, BUT COULD NOT REMOVE THEM. HE HAD TO RIP THE VESSEL TO REMOVE THE JAWS. HE CUT AND SUTURED TO REPAIR THE VESSEL. A NEW HANDPIECE WAS OPENED TO COMPLETE THE CASE. WHEN DISCUSSING THE CASE WITH THE REP HE MENTIONED THAT HE HAD SEALED THROUGH MUSCLE AND HAD MORE STICKING AFTER DOING SO. PATIENT IS STABLE AND WAS FINE AFTER VESSEL WAS REPAIRED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 20SEP2019, APPLIED MEDICAL ACCOUNT MGR I'VE ANSWERED ALL OTHER QUESTIONS WITH THE CER I STARTED YESTERDAY WITH YOU. TO TRY TO REMOVE THE JAWS FROM THE VESSEL, THEY POURED SALINE ON THE VESSEL ATTACHED TO JAWS. USED CLAMPS TO REMOVE JAWS FROM TISSUE. THE JAWS DID NOT GET LOCKED ON THE LATCHED POSITION. THE HANDLE WAS NOT GETTING STUCK IN THE LATCHED POSITION PREVENTING THE JAWS FROM OPENING. THE BLADE LEVER WAS NOT RETURNING TO THE FORWARD POSITION WHEN RELEASED. THERE WAS TISSUE DAMAGE AND BLEEDING. THERE WAS ONE INCIDENT OF THIS. THE SURGEON HAD TO REMOVE THE VESSEL THAT WAS STUCK TO THE JAWS WIT

  Patient problems: Tissue Damage

  MAUDE report 9136882 ↗
• InjuryApr 16, 2019Output Problem; Output Problem

  PROCEDURE PERFORMED: INTERVENTION ON HEMORRHOIDS YES I HAD THE OPPORTUNITY TO USE THE DEVICE FOR SURGERY ON HEMORRHOIDS. THE OPERATION WENT WELL, IN AN EXTREMELY SIMPLE WAY. UNFORTUNATELY THE PATIENT RETURNED 8 DAYS LATER FOR BLEEDING. THAT SAID, I DO NOT QUESTION THE MATERIAL AT ALL AND I WOULD LIKE TO CONTINUE TO BE ABLE TO USE IT. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY EMAIL ON 21MAR19: SURGEON RECENTLY TRIED VOYANT EB030 ON HEMORRHOIDS WITH MILLIGAN MORGAN TECHNIC. AS WRITTEN, PROCEDURE WENT WELL AND HANDPIECE WAS EASY TO USE. HOWEVER 8DAYS LATER, PATIENT CAME BACK FOR BLEEDING. DR DOESN'T INCRIMINATE (QUESTION) THE TECHNOLOGY NOR THE DEVICE. HE'D LIKE TO TRY AGAIN. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY EMAIL ON 8APR19: PATIENT STATUS IS FINE. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY EMAIL ON 18APR19: THE SURGEON DID A SUTURE WITH THREAD PATIENT STATUS: PATIENT STATUS IS FINE

  Patient problems: Injury

  MAUDE report 8520664 ↗
• MalfunctionFeb 14, 2019Output Problem; Output Problem

  PROCEDURE PERFORMED: TOTAL THYROIDECTOMY. INCIDENT DESCRIPTION: THE INTERVENTION ON THE RIGHT LOBE OF THE THYROID WENT WELL BUT ONCE ARRIVED ON THE DISSECTION OF THE SUPERIOR POLE OF THE LEFT LOBE AND AFTER HAVING ACTIVATED THE FUSION THEN SECTIONED, THERE WAS A BLEEDING AS IF THE FUSION HAD NOT WORKED. THE GENERATOR DID NOT REPORT ANY MALFUNCTION. THE SURGEON HAD TO STOP THE BLEEDING (CLASSIC BI-POLAR) WHICH WAS LONG AND COMPLICATED. IT WOULD SEEM, ACCORDING TO THE SURGEON AND HIS OPERATIVE ASSISTANCE, THAT A SUSPICIOUS NOISE WOULD HAVE BEEN HEARD JUST BEFORE THIS ACTIVATION. AN ELEMENT OF THE DEVICE WOULD HAVE BROKEN PREVENTING THE OPERATION OF THE FUSION BUT WITHOUT IT BEING REPORTED BY THE GENERATOR THE DEVICE HAS UNFORTUNATELY NOT BEEN PRESERVED. A SECOND EB030 WAS GIVEN TO THE SURGEON TO FINISH THE INTERVENTION. THERE WERE NO CONSEQUENCES FOR THE PATIENT OTHER THAN BLOOD LOSS AND THIS GENERATED A LOT OF STRESS FOR THE SURGEON AND HIS ENTIRE TEAM. ADDITIONAL INFORMATION RECEIVED BY PHONE FROM THE SALES REP ON 5FEB19: THERE WAS NO TENSION APPLIED TO A VESSEL OR BUNDLE THAT WAS BEING SEALED. WHEN THE SURGEON STARTED NOTICING THE INSUFFICIENT HEMOSTASIS, THE DEVICE WAS BEING USED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8340019 ↗
• MalfunctionApr 6, 2018Output Problem; Output Problem

  PROCEDURE PERFORMED: TRANSLATION AME: HEMORRHOIDECTOMY. TRANSLATION AME: THE SURGERY WENT WELL. AFTER A WHILE (EXACT TIME TO BE CONFIRMED) THERE WAS HEMORRHAGING. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY PHONE ON 15 MAR 2018: THERE WAS NO BLEEDING OBSERVED DURING THE SURGERY. SEALING A VESSEL OR TISSUE BUNDLE DID NOT DIRECTLY LEAD TO BLEEDING. SMALL ARTERIES AND HEMORRHOID TISSUE BUNDLE WERE BEING SEALED. DURING THE SURGERY THERE WAS NO INSUFFICIENT HEMOSTASIS OBSERVED. THERE WAS NO TENSION APPLIED TO A VESSEL OR BUNDLE THAT WAS BEING SEALED. THE PATIENT DID NOT EXHIBIT ANY VASCULAR PATHOLOGY. THE DEVICE WAS ACTIVATED ON SOME INFLAMED TISSUES. THE PATIENT WAS NOT GIVEN ANTICOAGULATION MEDICINE. THE HOSPITAL CONFIRMED THAT THESE INCIDENTS OCCURRED WITH 3 PATIENTS BETWEEN (B)(6) 2018 .PATIENT 3 WILL BE ASSOCIATED TO (B)(4). PATIENT STATUS: TODAY THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7403888 ↗
• MalfunctionApr 6, 2018Output Problem; Output Problem

  PROCEDURE PERFORMED: HEMORRHOIDECTOMY. INCIDENT DESCRIPTION: THE SURGERY WENT WELL. AFTER A WHILE (EXACT TIME TO BE CONFIRMED) THERE WAS HEMORRHAGING. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY PHONE ON 15 MAR 2018: THERE WAS NO BLEEDING OBSERVED DURING THE SURGERY. SEALING A VESSEL OR TISSUE BUNDLE DID NOT DIRECTLY LEAD TO BLEEDING. SMALL ARTERIES AND HEMORRHOID TISSUE BUNDLE WERE BEING SEALED. DURING THE SURGERY THERE WAS NO INSUFFICIENT HEMOSTASIS OBSERVED. THERE WAS NO TENSION APPLIED TO A VESSEL OR BUNDLE THAT WAS BEING SEALED. THE PATIENT DID NOT EXHIBIT ANY VASCULAR PATHOLOGY. THE DEVICE WAS ACTIVATED ON SOME INFLAMED TISSUES. THE PATIENT WAS NOT GIVEN ANTICOAGULATION MEDICINE. THE HOSPITAL CONFIRMED THAT THESE INCIDENTS OCCURRED WITH 3 PATIENTS BETWEEN (B)(6) 2018. PATIENT 2 WILL BE ASSOCIATED TO (B)(4). PATIENT STATUS: TODAY THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7403878 ↗
• MalfunctionApr 6, 2018Output Problem; Output Problem

  PROCEDURE PERFORMED: HEMORRHOIDECTOMIES. TRANSLATION: HEMORRHOIDECTOMY INCIDENT DESCRIPTION: TRANSLATION AME: THE SURGERY WENT WELL. AFTER A WHILE (EXACT TIME TO BE CONFIRMED) THERE WAS HEMORRHAGING. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY PHONE ON 15 MAR 2018: THERE WAS NO BLEEDING OBSERVED DURING THE SURGERY. SEALING A VESSEL OR TISSUE BUNDLE DID NOT DIRECTLY LEAD TO BLEEDING. SMALL ARTERIES AND HEMORRHOID TISSUE BUNDLE WERE BEING SEALED. DURING THE SURGERY THERE WAS NO INSUFFICIENT HEMOSTASIS OBSERVED. THERE WAS NO TENSION APPLIED TO A VESSEL OR BUNDLE THAT WAS BEING SEALED. THE PATIENT DID NOT EXHIBIT ANY VASCULAR PATHOLOGY. THE DEVICE WAS ACTIVATED ON SOME INFLAMED TISSUES. THE PATIENT WAS NOT GIVEN ANTICOAGULATION MEDICINE. THE HOSPITAL CONFIRMED THAT THESE INCIDENTS OCCURRED WITH 3 PATIENTS BETWEEN (B)(6) 2018. PATIENT 1 WILL BE ASSOCIATED TO (B)(4). PATIENT STATUS: TODAY THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7403843 ↗
• MalfunctionMar 13, 2018Output Problem; Output Problem

  PROCEDURE PERFORMED: TOTAL THYROIDECTOMY INCIDENT DESCRIPTION: PATIENT: FEMALE, (B)(6), HYPERTENSION, HYPERTHYROIDISM, NICOTINE ABUSE, OBESITY, NO ANTICOAGULANT MEDICATION, NO SPECIAL BLEEDING TENDENCY. SURGEONS USED THE EB030 FOR THE TOTAL THYROIDECTOMY. SURGEON USUALLY USES OVERHOLTS AND LIGATURES, BECAUSE OTHER SEALING DEVICES ARE TOO EXPENSIVE. THE INSTRUMENT WAS CLEANED REGULARLY DURING THE PROCEDURE AND WORKED RELIABLY. LARGE VESSELS WERE SUPPLIED WITH LIGATURES AND / OR SUTURES, BECAUSE BOTH SURGEONS HAVE GOOD EXPERIENCE WITH THIS. EB030 WAS USED FOR SMALLER VESSELS AND FOR PREPARATION. INSERTION OF A 10 CH REDON DRAINAGE. WOUND CLOSURE. DURING THE PROCEDURE, THE SURGEON TOUCHED THE SKIN ON THE EDGE OF THE WOUND WITH THE OUTSIDE OF THE BRANCH WHILE SEALING TISSUE, CAUSING TO BURNS (ATTACHED YOU´LL FIND A PHOTO) ADDITIONAL POINTS OF CRITICISM: THE HANDPIECE SHOULD BE MORE STABLE, ESPECIALLY AT THE TWO RING HANDLES. AFTER ACTIVATING THE BLADE, IT GETS STUCK SOMETIMES. ANYWAY I RECEIVED A POSITIVE FEEDBACK AFTER THIS CASE (SEE ATTACHED THE FEEDBACK FORM). AFTER ABOUT 1 HOUR, THE PATIENT HAD TO RETURN INTO THE OR, AS SHE HAD A LOT OF BLEEDING (ROUGHLY 400 ML). A FEW SMALL VEINS

  Patient problems: Burn(s); Injury

  MAUDE report 7336492 ↗
• MalfunctionJan 24, 2018Sticking; Sticking

  PROCEDURE PERFORMED: THYROIDECTOMY. TRANSLATION: SECOND TEST HIGHLIGHTS THE TENDENCY OF THE JAWS TO ADHERE TO TISSUES RAPIDLY, WITH CHARCOAL AND THEREFORE TO "BREAK"COAGULATION. THE CLAMP MUST BE CLEANED TOO OFTEN WHAT MAKES HIM LOSE TIME. GENERATOR & DEVICE SETUP: WANTED A COMPATIBLE GENERATOR WITH MONOPOLAR AND BIPOLAR STANDARD. HANDLE ERGONOMICS: VERY GOOD. SEALING PERFORMANCE: THERMAL SPREAD - GOOD. SEALING PERFORMANCE: HEMOSTASIS - GOOD. PATIENT STATUS: NI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7217430 ↗
• MalfunctionJan 24, 2018Sticking; Sticking

  PROCEDURE PERFORMED: THYROIDECTOMY. PROCEDURE MINUTES - 30. ORIGINAL: GENERATOR AND DEVICE SETUP: "BON" SEALING PERFORMANCE: "CHARBONNAGE; IMPORTANT ET RAPIDE, LES MORS SE SALISSENT TRES RAPIDEMENT MALGRE NETTOYAGE PERMANENT" HANDLE ERGONOMICS: "BON" "PROBLEME IMPORTANT AVEC LES MORS, APRES FUSION LES TISSUS RESTENT COLLES SUR LA PINCE ,LE CHIRURGIEN TROUVE CET INCONVENIENT TRES ENNUYANT. LORS DISSECTION NERF RECURRENT LE CHIR A FUSIONNE VAISSEAU PROCHE, AU MOMENT D'ENLEVER LA PINCE CELLE CI EST RESTE FIXEE AU TISSU ET LE CHIR A EVITE DE PEU DE SECTIONNER LE NERF PAR ARRACHEMENT. IL A DONC CONSIDERE LE DISPOSITIF COMME DANGEREUX ET A UTILISE LA COVIDIEN . IL N'A PAS AVEC CELLE CI RENCONTRE CE PROBLEME DE TISSUS ADHERENTS AUX MORS ET N'A PAS NON PLUS DU NETTOYER CEUX CI. POUR LUI IL EXISTE UN REEL PROBLEME D'ADHERENCE DES TISSUS APRES FUSION, IL M'A SIGNALE QUE LES PREMIERES GENERATIONS DE COVIDIEN AVAIT POSE LE MEME SOUCIS ET QUE CECI AVAIT ETE CORRIGE.....J'AI DONC DECIDE DE FAIRE UN CER SUR LE DISPOSITIF....ANTOINE BOULE EST PREVENU" SEALING PERFORMANCE: "MOINS RAPIDE QUE COVIDIEN" TRANSLATION: GENERATOR AND DEVICE SETUP - "GOOD" SEALING PERFORMANCE - ""CHARRING" SIGNIFICANT AND

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7217423 ↗
• MalfunctionDec 5, 2017Sticking; Failure to Cut; Sticking; Failure to Cut

  PROCEDURE PERFORMED: THYREOIDEKTOMIE. TRANSLATION AME: THYROIDECTOMY. WÄHREND DES OP-VERLAUFS LIESS DIE SCHNEIDEQUALITÄT LAUT AUSSAGE VON FRAU DR. NACH. DAS GEWEBE WURDE NICHT MEHR KOMPLETT (15MM SCHNITTLÄNGE) GESCHNITTEN, SONDERN DAS GEWEBE KLEBTE AN DEN BRANCHEN UND STATT 2 MM (DIFFERENZ ZWISCHEN SCHNITT- UND VERSIEGELUNGSLÄNGE) WAREN ES LAUT FRAU DR. SPARLA CA. 4 MM. WÄHREND DES EINGRIFFS AUF DAS REINIGEN DER BRANCHEN HINGEWIESEN, AUSSAGE VON FRAU DR. "BEIM SMALL JAW MÜSSTE MAN DIE BRANCHEN NICHT REINIGEN". DIE REINIGUNG DER BRANCHEN WURDE TROTZ MEHRFACHER HINWEISE DURCH DEN TM AUCH NUR SPARSAM VOM OP-TEAM UMGESETZT. ZUDEM KAM ES ZU PROBLEMEN BEIM SCHNEIDEN, DA DIE KLINGEN BLOCKIERTEN. DIES KONNTE DURCH MEHRMALIGES AKTIVIEREN DER KLINGEN IM GESCHLOSSEN ZUSTAND BEHOBEN WERDEN. AUSSAGE VON FRAU DR. "IHR PRODUKT SCHNEIDET NICHT RICHTIG, ES TUT NICHT DAS WAS ES TUN SOLL". TRANSLATION AME: DURING THE SURGERY, THE CUTTING QUALITY DECREASED ACCORDING TO DOCTOR. THE TISSUE WASN'T CUT COMPLETELY ANYMORE (15 MM CUTTING LENGTH), AND THE TISSUE STUCK TO THE JAWS. INSTEAD OF 2 MM (DIFFERENCE BETWEEN CUTTING AND SEALING LENGTH) IT WERE APPROXIMATELY 4 MM ACCORDING TO DOCTOR. INDICATED DURING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085430 ↗
• MalfunctionOct 23, 2017Sticking; Sticking

  PROCEDURE PERFORMED: THYROIDECTOMY. "THE EB030 WAS CONSTANTLY STUCK TO THE TISSUE AND WHEN THEY OPEN THE JAWS IT WAS BLEEDING . IT IS CLEANED REPEATEDLY BUT STILL THE SAME. FEELING THAT IT PRODUCED TOO MUCH ENERGY AND A LOT OF ESCHAR. AT THE END THE CUT GOT STUCK. WE CHANGE TO ANOTHER EB030, WITH THE SAME LOT SERIAL, AND ONLY PASTE ONCE TIME. THE PATIENT IS WITH DYSPHONIA NOW. THE SURGEON DOUBTS IF IT´S DUE TO EXCESSIVE MANIPULATION OR EXCESS OF ENERGY THAT HAS AFFECTED THE RECURRENT NERVE. PATIENT WILL BE MONITORED ON SUBSEQUENT DAYS. THERE ARE NO BLEEDING PROBLEMS." ADDITIONAL INFO RECEIVED FROM REGIONAL SALES MANAGER BY EMAIL ON 23OCT2017: TERRITORY MANAGER FOLLOWED UP WITH DOCTOR THIS MORNING. THE PATIENT IS NOW AT HOME AND HAS APPOINTMENTS NEXT WEEK. THE DOCTOR DOES NOT KNOW IF THE DYSPHONIA IS STILL PRESENT, PROBABLY NOT, BUT NEXT WEEK SHE WILL INFORM US. IF THERE IS ANY NEWS, SHE WILL INFORM US TOO. PATIENT STATUS: "SOME DYSPHONIA, THEY DON´T KNOW IF IT´S TO MANIPULATION TISSUE OR EXCESSIVE ENERGY." UPDATED PATIENT STATUS RCVD 23OCT2017: PATIENT IS AT HOME, UNKNOWN IF DYSPHONIA IS STILL PRESENT. INTERVENTION: CHANGE TO ANOTHER EB030.

  Patient problems: Injury

  MAUDE report 6970603 ↗
• MalfunctionOct 16, 2017Sticking; Sticking

  PROCEDURE PERFORMED: TOTAL THYROIDECTOMY. THE EB030 DEVICE WORKED VERY WELL WHEN REMOVING THE RIGHT THYROID LOBE. ON THE OTHER HAND, ONCE THE SURGEON HAS PASSED ON THE LEFT LOBE, SEVERE ADHESIONS HAVE TAKEN PLACE, WEAKENING THE HAEMOSTASIS WHICH HAD BEEN DONE BEFOREHAND, SINCE IT WAS NECESSARY TO PULL THE TISSUES IN ORDER TO DETACH THE JAWS OF THE DEVICE. AND THIS DESPITE THE REGULAR CLEANING OF THE JAWS. THE SURGEON DECIDED TO TAKE A NEW DEVICE TO REMEDY THESE ADHERENCES OF THE TISSUES TO THE JAWS OF THE DEVICE. THERE WERE NO CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP ON 02 OCT 2017: THERE WAS SMALL BLEEDING AFTER THE SURGEON TOOK OFF THE SEALED TISSUS FROM THE JAW. PATIENT STATUS: THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6953253 ↗
• MalfunctionOct 6, 2017Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: PAROTIDECTOMY. DURING THE PROCEDURE, 1 HOUR AFTER THE START OF THE PROCEDURE, THE BUTTON OPERATING THE KNIFE HAS BROKEN, DISENGAGED FROM THE SPRING ACTUATING THE KNIFE, THE BLADE CAME OUT WHILE THE JAWS WERE OPEN. THIS INCIDENT MADE IMPOSSIBLE THE USE OF THE DEVICE, ANOTHER VOYANT DEVICE WAS GIVEN TO THE SURGEON. THERE WAS NO CONSEQUENCE ON THE PATIENT. THE DEVICE HAS BEEN PRESERVED AND CAN BE COLLECTED AT THE PHARMACY. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP ON 02 OCTOBER 2017: THE SURGEON USES REGULARLY OUR EB030 SINCE MORE THAN A YEAR AND I DID NOT NOTICE ANY MODIFICATION IN THE WAY THAT HE HAD TO USE IT. THE SURGEON RESPECTS THE APPLIED MEDICAL RECOMMENDATIONS AND DOES NEVER SEAL VESSELS WITH DIAMETER GREATER THAN 7MM. I DID NOT OBSERVE ANY TORQUE BEING APPLIED WHEN THE SURGEON POSITIONED THE DEVICE ON TISSUES. THE SURGEON WAS MANIPULATING VESSELS NEARBY THE PAROTID. THE SIZE OF THE VESSELS IS UNKNOWN. PATIENT STATUS: NO CONSEQUENCE ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6925715 ↗
• MalfunctionJun 13, 2017Break; Break

  ADDITIONAL INFO RECEIVED FROM APPLIED TEAM MEMBER, 31ST JULY: "AS FAR AS I AM AWARE THE TISSUE BEING GRASPED AT THE TIME WAS THE VAGINAL CUFF WHERE THERE SHOULDN'T HAVE BEEN ANY TUMOUR DUE TO THE MARGINS TAKEN DURING THE LAVH. I AM FAIRLY CERTAIN IT WAS SOFT TISSUE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6638961 ↗
• MalfunctionMay 26, 2017Sticking; Sticking

  PROCEDURE PERFORMED: HEMITHYROIDECTOMY. HEMITHYROIDECTOMY PERFORMED IN A (B)(6) PATIENT BECAUSE OF GOITER. SHE IS NOT UNDER ANY SPECIAL MEDICATION (IBUPROFENO). SHE HAD BEEN UNDER SURGERY IN THE PAST, FALLOPIAN TUBES WERE REMOVED. DR. STARTS SURGERY USING EB030 BOTH DISSECTING AND SEALING ALL THE TIME. AFTER AROUND 35 ACTIVATIONS IN THE PEDICLE AREA, TISSUE GETS STICKED TO THE JAWS. AT THIS POINT JAWS HAD BEEN CLEANED ONCE (EVEN THOUGH I INSISTED ON THEM BEING CLEANED MORE OFTEN). BECAUSE OF THE STICKING MINOR BLEEDING TOOK PLACE WHEN BE TRIED TO REMOVE THE JAWS ATTACHED TO THE TISSUE. AFTER THIS FIRST INCIDENT ANOTHER 10 ACTIVATIONS TOOK PLACE. JAWS WERE CLEANED ANOTHER 3 TIMES BUT STILL 3 OTHER STICKING EPISODES TOOK PLACE. AGAIN, WHEN DR. REMOVED THE DEVICE JAWS FROM THE TISSUE MINOR BLEEDINGS WOULD HAPPEN. AT THIS POINT DR. REFUSED TO KEEP ON USING VOYANT AND HE ASKED FOR LIGASURE SMALL JAW TO BE OPENED. PARAPHRASING THE DR. "FROM ZERO TO TEN, THE CONFIDENCE THAT YOUR DEVICE GIVES ME IS ZERO, WE USED LIGASURE WITHOUT CLEANING IT EVEN ONCE TO FINISH THE PROCEDURE AND YOU COULD SEE IT NEVER GOT STICKED". PATIENT STATUS- NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6595071 ↗
• MalfunctionApr 25, 2017Failure to Cut; Failure to Cut

  TOTAL THYROIDECTOMY "TOTAL OF THREE DEVICES WERE OPENED. FIRST DEVICE HAD SEVERAL CHECK DEVICE ALARMS AND WAS NOT CUTTING PROPERLY. SECOND DEVICE WAS OPENED, PLUGGED INTO GENERATOR, AND WOULD NOT ACTIVATE. THIRD DEVICE HAD SEVERAL CHECK DEVICE ALARMS ON THIN TISSUE AND DID NOT SEAL TISSUE PROPERLY, DURING THE SEAL CYCLE, THE TISSUE FELL OUT OF THE JAWS INCOMPLETELY ON OCCASION." PATIENT STATUS- NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6520592 ↗
• MalfunctionApr 22, 2017Sticking; Sticking

  SURGERY STARTED AT 12.30, PATIENT WAS A (B)(6) OBESE WOMAN. HALF LEFT THYROID BEING REMOVED DUE TO GOITER DISEASE. SURGEON DECIDED TO TRY BOTH LIGASURE SMALL JAW AND VOYANT FINE FUSION AT THE SAME TIME TO COMPARE THEM SIDE BY SIDE. BOTH DEVICES' JAWS WERE BEING CLEANED NONSTOP EVERYTIME THE SURGEON WOULD PLACE THEM DOWN BY THE SCRUB NURSE. NURSE WOULD COMPLAIN ABOUT VOYANT GETTING TOO MUCH "SCHAR" ATTACHED. SHE REALLY TRIED TO CLEAN IT IN DEEP EVERY SINGLE TIME DEVICE WAS NOT BEING USED. DURING THE FIRST 25-30 ACTIVATIONS SOME ERRORS TOOK PLACE. MAYBE (ACCORDING TO WHAT I WAS ABLE TO SEE) BECAUSE OF SURGEON OPENING THE JAWS BEFORE CYCLE BEING COMPLETED. AROUND THE 30TH ACTIVATION FIRST STICKING ISSUE TOOK PLACE. NOT TOO SEVERE BUT NOTICEABLE. THE NEXT 25 ACTIVATIONS MANY ERRORS WOULD TAKE PLACE. IT SEEMED THE SURGEON WAS PRESSING THE JAWS FIRMLY. STICKING STARTED ALSO OCCURRING EVERY 4-5 ACTIVATIONS. AT SOME POINTS STICKING WAS SO SEVERE IT WOULD TURN INTO AN ERROR OR SURGEON HAD TO USE SCALPEL TO SEPARATE THE TISSUE IN BETWEEN THE JAWS. ALL THE PROCEDURE WAS PERFORMED 50-50 BY LIGASURE SMALL JAW AND VOYANT FINE. WITH AROUND 60 ACTIVATIONS EACH. SURGEON WOULD BRING UP THE FACT OF S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6513669 ↗
• InjuryApr 13, 2017Output Problem; Output Problem

  PROCEDURE PERFORMED- THYROIDECTOMY: PATIENT UNDER PREVISCAN (OBJECTIVE INR 2-3). RELAY 5 DAYS BEFORE THE INTERVENTION BY LOVENOX. TOTAL THYROIDECTOMY ON (B)(6) FOR GOITRE MULTI HETERO NODULAR BASEDOWIFIED. RESUMPTION OF THE PREVISCAN AT THE REMOVAL OF THE REDONS, AT DAY 2. SURGICAL RECOVERY ON (B)(6) 2017 ORIGINAL: PATIENT SOUS PREVISCAN (OBJECTIF INR 2-3). RELAIS 5 JOURS AVANT L'INTERVENTION PAR LOVENOX. THYROÏDECTOMIE TOTALE LE (B)(6) POUR GOÎTRE MULTI HÉTÉRO NODULAIRE BASEDOWIFIÉ. REPRISE DU PREVISCAN À L'ABLATION DES REDONS, À J2. REPRISE CHIRURGICALE LE (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED FROM CLINICAL AND SALES REP ON 12 APR 2017: BEFORE CONVERTING TO THE VOYANT FINE FUSION DEVICE THE SURGEONS WERE USING STANDARD BIPOLAR AND SOMETIMES CLIPS FOR THESE SURGERIES. THE ACCOUNT HAS BEEN USING VOYANT FINE FUSION DEVICE FOR ROUGHLY 3 MONTHS NOW. INITIAL EVENT DESCRIPTION COMMUNICATED BY THE SALES REP IS DESCRIBING THE RETURN OF THE PATIENT TO OPERATING ROOM AFTER DAY 7. COMPLAINT: BLEEDING 7 DAYS AFTER THE SURGERY. PATIENT STATUS:SURGICAL RECOVERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6492358 ↗
• InjuryApr 13, 2017Output Problem; Output Problem

  PROCEDURE PERFORMED: THYROIDECTOMY PATIENT UNDER PREVISCAN (OBJECTIVE INR 2-3). RELAY 5 DAYS BEFORE BY LOVENOX 0.7ML 2 / D. TOTAL THYROIDECTOMY ON (B)(6) 2017 FOR THYROID GLAND BASED. RESUMPTION OF PREVISCAN ON DAY 2 IN RELAY. SURGICAL RECOVERY ON (B)(6) 2017 ORIGINAL: PATIENT SOUS PREVISCAN (OBJECTIF INR 2-3). RELAIS 5 JOURS AVANT PAR LOVENOX 0.7ML 2/J. THYROIDECTOMISE TOTALE LE (B)(6) 2017 POUR GOÏTRE THYROÏDIEN BASEDOWIFIÉ. REPRISE DU PREVISCAN À J2 EN RELAIS. REPRISE CHIRURGICALE LE (B)(6) 2017 ADDITIONAL INFORMATION RECEIVED FROM CLINICAL AND SALES REP ON (B)(6) 2017: BEFORE CONVERTING TO THE VOYANT FINE FUSION DEVICE THE SURGEONS WERE USING STANDARD BIPOLAR AND SOMETIMES CLIPS FOR THESE SURGERIES. THE ACCOUNT HAS BEEN USING VOYANT FINE FUSION DEVICE FOR ROUGHLY 3 MONTHS NOW. INITIAL EVENT DESCRIPTION COMMUNICATED BY THE SALES REP IS DESCRIBING THE RETURN OF THE PATIENT TO OPERATING ROOM AFTER DAY 6. COMPLAINT: BLEEDING 6 DAYS AFTER THE SURGERY. PATIENT STATUS: SURGICAL RECOVERY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6492355 ↗
• InjuryApr 13, 2017Output Problem; Output Problem

  ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 19 APRIL 2017 : THE DEVICE FUNCTION NORMALLY DURING THE PROCEDURE. THERE ISN'T MORE BLEEDING THAN USUAL. THERE WAS NO ALARM TONE DURING ANY OF THE PROCEDURE. THERE WAS NOT CONDUCTIVE FLUID OR BLOOD POOLING AROUND THE JAWS BEFORE SEALING. THE NURSE USE TO CLEAN THE DEVICES AFTER ONE OR TWO FUSION CYCLES - NOT EXCESSIVE ESCHAR ON THE JAWS. THE PATIENT WAS ON ANTICOAGULANT. HE USES THE VOYANT SINCE A FEW MONTHS, SO HE MAKES A CONNECTION - IT'S DIFFICULT TO KNOW IF THE BLEEDING COMES FROM SPECIFICALLY FROM VESSELS SEALED WITH FINE FUSION ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 27 APRIL 2017 : THE SURGEON IS USED TO TAKE SCISSORS AND BIPOLAR IN ADDITION TO THE FINE FUSION VOYANT, FOR ALL THYROIDECTOMY. BEFORE USING FINE FUSION HE USED SOME CLIPS FOR THE BIGGEST VESSELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6492354 ↗
• InjuryApr 13, 2017Output Problem; Output Problem

  PROCEDURE PERFORMED: THYROIDECTOMY USUAL TREATMENT: ASPEGIC 100 MG AND PREVISCAN (OBJECTIVE INR 2-3) THYROIDECTOMY FOR GOITRE BASED ON THE (B)(6) 2017. STOP OF PREVISCAN 5 DAYS BEFORE, RELAY LOVENOX 0.6 ML 2 / D. STOP THE LOVENOX THE DAY BEFORE THE INTERVENTION. RESUMPTION IN IMMEDIATE POST-OP. STOP ASPÉGIC STOPPED THE (B)(6), RESUMED AT D2. SURGICAL RECOVERY ON (B)(6) 2017 ORIGINAL: TRAITEMENT HABITUEL : ASPEGIC 100 MG ET PREVISCAN (OBJECTIF INR 2-3) THYROÏDECTOMIE POUR GOÎTRE BASEDOWIFIÉ LE (B)(6) 2017. ARRÊT DU PREVISCAN 5 JOURS AVANT, RELAIS LOVENOX 0.6 ML 2/J. STOP LE LOVENOX LA VEILLE DE L'INTERVENTION. REPRISE EN POST-OP IMMÉDIAT. ARRÊT ASPÉGIC STOPPÉ LE (B)(6), REPRIS À J2. REPRISE CHIRURGICALE LE (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED FROM CLINICAL AND SALES REP ON 12 APR 2017: BEFORE CONVERTING TO THE VOYANT FINE FUSION DEVICE THE SURGEONS WERE USING STANDARD BIPOLAR AND SOMETIMES CLIPS FOR THESE SURGERIES. THE ACCOUNT HAS BEEN USING VOYANT FINE FUSION DEVICE FOR ROUGHLY 3 MONTHS NOW. INITIAL EVENT DESCRIPTION COMMUNICATED BY THE SALES REP IS DESCRIBING THE RETURN OF THE PATIENT TO OPERATING ROOM AFTER DAY 5. COMPLAINT: BLEEDING 5 DAYS AFTER THE SURGERY. PATIENT STA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6492353 ↗
• InjuryApr 13, 2017Output Problem; Output Problem

  PROCEDURE: LOBOISTHMECTOMY. NO ANTICOAGULANT TREATMENT. LOBOISTHMECTOMY LEFT FOR GOITER MULTI HETERO NODULAR ON "(B)(6) 2017." RETURN AT DAY 0. ORIGINAL: PAS DE TREATMENT ANTICOAGULANT. LOBOISTHMECTOMIE GAUCHE POUR GOÎTRE MULTI HÉTÉRO NODULAIRE LE "(B)(6) 2017." REPRISE À J0. ADDITIONAL INFORMATION RECEIVED FROM CLINICAL AND SALES REP ON 12 APR 2017: BEFORE CONVERTING TO THE VOYANT FINE FUSION DEVICE THE SURGEONS WERE USING STANDARD BIPOLAR AND SOMETIMES CLIPS FOR THESE SURGERIES. THE ACCOUNT HAS BEEN USING VOYANT FINE FUSION DEVICE FOR ROUGHLY 3 MONTHS NOW. COMPLAINT: BLEEDING AFTER SURGERY. INITIAL EVENT DESCRIPTION COMMUNICATED BY THE SALES REP IS DESCRIBING THE RETURN OF THE PATIENT TO OPERATING ROOM ON SAME DAY AS THE SURGERY. PATIENT STATUS- SURGICAL RECOVERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6492352 ↗
• MalfunctionApr 7, 2017Failure to Cut; Failure to Cut

  PROCEDURE PERFORMED UNKNOWN- AFTER 10 MINUTES THE DEVICE WOULDN'T CUT ANYMORE. TO FINISH THE PROCEDURE THE DEVICE HAS BEEN REPLACED BY ANOTHER ONE WITH A DIFFERENT LOT NUMBER AND EVERYTHING WENT FINE. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 24 MARCH 2017: STANDARD TISSUE, SECTION OF THE PARAMETER DURING A VAGINAL HYSTERECTOMY. HE EXPERIENCED A SMALL RESISTANCE WHEN HE TRIED TO ACTIVATE THE BLADE. THERE WAS NO SEPARATION BUT HE NOTICED THAT THE HANDLE DIDN'T SEEMED TO BE WELL IN THE AXIS, EVEN TO LAUNCH A FUSION CYCLE HE TOLD ME THAT HE HAD TO BE CAREFUL TO BE ABLE TO MAKE THE CONTACT BETWEEN THE TWO PARTS. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6474309 ↗
• MalfunctionMar 30, 2017Failure to Cut; Failure to Cut

  MASTECTOMY WITH AXILLARY NODE - "DURING USE OF THE VOYANT DEVICE, THE SCISSORS DID NOT CUT OR CUT LESS, DESPITE REGULAR CLEANING OF THE DEVICE." ORIGINAL:LORS DE L'UTILISATION DE LA PINCE THERMOFUSION VOYANT, LE CISEAU NE COUPAIT PAS OU PEU, MALGRÉ LE NETTOYAGE DE LA PINCE. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP ON 27 MARCH 2017: "DESPITE THE BAD QUALITY OF CUTTING SHE USED THE EB030 HAND PIECE DURING ALL THE PROCEDURE SHE JUST USED A SCISSORS TO HAVE A GOOD CUTTING => THE TIME PROCEDURE WAS LONGER. ALL TYPE OF TISSUE (FAT, MUSCLES, VASCULAR...) WERE CUT DURING THE EVENT. SHE NOTICED THE BAD CUTTING QUALITY FROM THE BEGINNING OF THE PROCEDURE." PATIENT STATUS - "NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6448036 ↗
• MalfunctionMar 27, 2017Sticking; Failure to Cut; Sticking; Failure to Cut

  HEMI THYROIDECTOMY - "START PROCEDURE; SKIN WAS INCISED WITH KNIFE BLADE. DISSECTION OF SUBCUTANEOUS TISSUE WAS DONE WITH A NEEDLE ELECTRODE UNTIL THE THYREOID GLAND WAS VISIBLE. BLUNT DISSECTION WAS PERFORMED WITH A DISSECTOR TO FREE UP THE BLOOD VESSELS AND SMALL TISSUE BUNDELS. VOYANT WAS USED TO SEAL AND DISSECT. DURING THE FIRST 10 ACTIVATIONS SEALING AND DISSECTION OF THE SEAL WAS NORMAL. AFTER EVERY 2 TO 3 ACTIVATIONS THE JAWS WERE CLEANED WITH A WET GAUZE BECAUSE OF ESCHAR BUILUP. AFTER 10 ACTIVATIONS THE SURGEON AND SCRUB NURSE STARTED TO NOTICE THAT TISSUE BEGAN TO STUCK TO THE JAWS. THEY HAD TO USE A FORECEPS TO GET THE SEALED TISSUE FROM THE JAWS. THEY STARTED CLEANING THE JAWS AFTER EVERY ACTIVATION. STICKINESS KEPT HAPPENING. IT WAS ALSO NOTICED THAT THE KNIFE BLADE DIDN'T CUT THE SEAL COMPLETELY. MEANING THAT THEY HAD TO USE A SCISSOR TO DEVIDE SOME REMANING SEALPARTS. IT WAS NOTICED THAT THE COLOR OF THE JAWS OF THE VOYANT CHANGED, BECAME MORE GREY/BLACK AFTER 10/15 ACTIVATIONS. THE OPERATING TEAM DECIDED TO USE STANDARD BIPOLAR OR USING SCISSORS INSTEAD OF USING VOYANT BECAUSE THIS WAS LESS TIME CONSUMING." PATIENT STATUS - NO PATIENT INJURY OR ILLNESS OCCUR ASSOCI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6437719 ↗