VOYANT® 5mm Fusion Device EB011Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607915134754), received between Mar 4, 2017 and Dec 18, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2019Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAR. EVENT DESCRIPTION: REP. WASN'T PRESENT FOR THE CASE, BUT DID HAVE A CHANCE TO SPEAK WITH THE SURGEON AFTER THE CASE HAD BEEN COMPLETED. SURGEON TOLD REP. THAT AT THE BEGINNING OF THE CASE, AFTER 3 ACTIVATIONS, WHEN HE TRIED TO TRANSECT THE TISSUE, IT FAILED TO CUT. THE HANDPIECE DID SEAL CORRECTLY, BUT THERE WAS NO CUTTING. THE SURGEON DIDN'T EXPERIENCE ANY RESISTANCE OR DIFFICULTY WHEN ACTUATING THE BLADE LEVER. THE REP. IS UNSURE AS TO EXACTLY WHAT KIND OF TISSUE WAS BEING CUT AT THE TIME, BUT STATED THAT IT WAS THIN TISSUE (POSSIBLY MESENTERY TISSUE) THAT WASN'T GREATER THAN 7 MM. THE BLADE WASN'T CUTTING AT ALL AND HARDLY ANY TISSUE HAD BEEN CUT WHEN THE BLADE WAS ACTIVATED (PERCENTAGE INFORMATION WAS UNAVAILABLE). THE SURGEON SWITCHED TO USING ANOTHER EB011 TO COMPLETE THE CASE WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY AND THE PRODUCT IS EXPECTED TO RETURN. TYPE OF INTERVENTION: SWITCHED TO USING ANOTHER EB011 TO COMPLETE THE CASE WITHOUT ANY FURTHER ISSUES. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490800 ↗
• MalfunctionNov 7, 2019Unintended Power Up; Unintended Power Up

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY CONVERTED OPEN. EVENT DESCRIPTION: REP. WAS PRESENT FOR THE CASE. HE STATED THAT IT WAS A LONG CASE THAT STARTED AT 9:00 AM. THE VOYANT EB011 HANDPIECE WAS USED FOR AROUND 4 HOURS. AROUND THE 4 HOUR MARK, WHICH WAS THE LAST TIME IT WAS USED, THE "RE-ACTIVATE DEVICE" ERROR APPEARED. AFTER THE 10TH/11TH ATTEMPT TO RE-ACTIVATE THE DEVICE, IT MANAGED TO COMPLETE 1 SEAL CYCLE. AFTER THIS, THE DEVICE WAS SET ASIDE SINCE IT WAS THE LAST TIME THE SURGEON NEEDED TO USE THE HANDPIECE (PER THE REP., THE DOCTOR SWITCHED TO USING MONOPOLAR SINCE ADVANCED BIPOLAR WAS NO LONGER NEEDED). 1 HOUR LATER AFTER THE DEVICE HAD BEEN SET ASIDE, THE REP. NOTICED THAT THE HANDPIECE HAD MIRACULOUSLY DECIDED TO ACTIVATE ON ITS OWN WITH THE JAWS OPEN - IT EVEN MANAGED TO COMPLETE 1 SEAL CYCLE. IT ACTUALLY WENT THROUGH SEAL CYCLES 4 TIMES BEFORE BEING UNPLUGGED BY THE REP. AFTER IT WAS UNPLUGGED AND THEN RE-PLUGGED BACK IN BY THE REP, THE HANDPIECE, ONCE AGAIN, WENT THROUGH 1 SEAL CYCLE. ALL SEAL CYCLES HAPPENED OUTSIDE THE PATIENT (I.E. NO PATIENT CONTACT) SINCE IT WAS AFTER USE. THE PRODUCT IS AVAILABLE FOR RETURN AND THERE WAS NO PATIENT INJURY. TYPE OF INTER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9293838 ↗
• MalfunctionFeb 15, 2019Mechanical Problem; Mechanical Problem

  PROCEDURE PERFORMED: SIGMA RESECTION / SIGMOID RESECTION. DURING PREPARATION AND SEALING DUE TO INDUSTRIES DID NOT CLOSE ANYMORE AND THE BLADE MOVED FROM THE OUTSIDE VISIBLE TO THE FRONT. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE VIA PHONE ON 22JAN2019: AFTER ABOUT AN HOUR, AN HOUR AND A HALF, THERE WAS A CRACKING NOISE FROM THE HANDPIECE WHEN THE SURGEON WAS DOING THE PREPARATION OF THE TISSUE. AFTER THIS, THE JAWS WOULDN¿T CLOSE ANYMORE. THE BLADE COULD BE ADVANCED WITH THE JAWS OPEN. THE HANDPIECE WAS EXCHANGED FOR ANOTHER AND THE SURGERY COULD BE FINISHED WITHOUT ISSUES. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT. INTERVENTION: CHANGE OF DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8344728 ↗
• MalfunctionJun 13, 2017Output Problem; Output Problem

  PROCEDURE PERFORMED: GASTREKTOMIE-SLEEVE. ORIGINAL: IN LAUFE DER OP NAHM DIE ENERGIELEISTUNG UNSERES SYSTEMS AB, SO DASS AUCH KLEINLUMIGE GEFÄSSE NICHT KOMPLLETT VERSIEGELT WERDEN KONNTEN. IM WEITEREN VERLAUF DER OPERATION MUSSTE DR. HERRFUTH AUF EIN ETTBEWERBSPRODUKT INTRAOPERATIV UMSTELLEN. TRANSLATION BY REGIONAL SALES MANAGER: IN THE COURSE OF THE OPERATION, THE ENERGY OUTPUT OF OUR SYSTEM DECREASED, SO THAT EVEN SMALL-LUMEN VESSELS COULD NOT BE COMPLETELY SEALED. IN THE FURTHER COURSE OF THE OPERATION DR. HERRFUTH HAD TO SWITCH TO A COMPETITION PRODUCT INTRAOPERATIVELY. ADDITIONAL INFORMATION RECEIVED FROM REP ON 2JUN2017: THERE WERE HEMOSTASIS ISSUES; SHORTLY AFTER THE SEALING CYCLE WAS COMPLETED, THE BLOOD VESSELS STARTED BLEEDING AGAIN. THE USER NOTICED THE DECREASE IN RF-OUTPUT, BECAUSE AT THE BEGINNING OF THE SURGERY, THIS PROBLEM DIDN'T EXIST YET. THE GENERATOR DID EMIT THE TONE THAT THE SEAL CYCLE WAS COMPLETE, AND THERE WERE NO ALARMS. TYPE OF INTERVENTION: N/A. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6638944 ↗
• MalfunctionMay 22, 2017Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: SLEEVE GASTRECTOMY. DEVICE STAYED BLOCKED IN CLOSE POSITION AT THE THIRD SEALING. THE SURGEON WAS ABLE TO REMOVE THE DEVICE FROM THE TISSUES WITHOUT DIFFICULTY AND TOOK ANOTHER DEVICE TO COMPLETE THE PROCEDURE. LA PINCE EST RESTEE BLOQUEE EN POSITION FERMEE À LA TROISIEME COAGULATION. LE CHIRURGIEN A PU RETIRER LE DISPOSITIF DES TISSUS SANS DIFFICULTÉ PUIS A REPRIS UN AUTRE DISPOSITIF POUR FINIR SON INTERVENTION. ADDITIONAL INFORMATION RECEIVED FROM REP ON 3 MAY 2017: THE JAWS OF THE DEVICE COULD NOT BE REOPENED. THE SURGEON PULLED IT OUT, THEREBY TEARING THE TISSUE, AND REALIZED HEMOSTASIS WITH THE SECOND DEVICE. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 4 MAY 2017: THE INFORMATIONS GIVEN BY THE HOSPITAL ARE THE GOOD ONES. PRODUCT CODE EB011 LOT 1282637. DATE OF EVENT (B)(6) 2017. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6582004 ↗
• InjuryApr 20, 2017Output Problem; Output Problem

  PROCEDURE PERFORMED: GASTRIC SLEEVE. ORIGINAL: SANGRADO DIFERIDO TRAS GASTRIC SLEEVE CON GELPOINT Y VOYANT DE 44CM A UNA PACIENTE DE 32 AÑOS QUE NO TOMABA NINGÚN TIPO DE MEDICACIÓN Y CON NIVELES DE COAGULACIÓN NORMALES. TUVO QUE SER REINTERVENIDA A LAS 24 HORAS POR SANGRADO EN LA LÍNEA DE SECCIÓN DEL EPIPLÓN, NO EN LA DE GRAPAS (YA QUE LOS COÁGULOS FORMADOS SE ENCONTRABAN DEBAJO DE ÉSTA). LA PACIENTE SANGRÓ CASI 1 LITRO, TUVIERON QUE PONERLE UNAS 4 BOLSAS DE SANGRE. TRANSLATION: BLEEDING DEFERRED AFTER A SLEEVE GASTRECTOMY WITH GELPOINT AND VOYANT IN A PATIENT OF (B)(6) THAT SHE DIDN'T TAKE ANY MEDICATION AND WITH NORMAL LEVELS OF COAGULATION. IT HAD TO BE OPERATED AGAIN IN THE EPIPLON ( MESENTERY) NOT IN THE STAPLER LINE ( BECAUSE THE BLOOD CLOTS WERE BELOW OF THAT) THE PATIENT LOST 1 LITER OF BLOOD AND THEY USES 4 BAGS OF BLOOD TO RECOVER THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM TEAM MEMBER ON 18 APRIL 2017: THE HANDPIECE CANNOT BE RETURNED, BECAUSE IT WAS THROWN AWAY AFTER SURGERY. APRIL 6 WAS THE DATE OF THE FIRST SURGERY, APRIL 7 THE DATE OF THE SECOND SURGERY. THE SURGEON DID NOT NOTICE ANY DIFFICULTIES WITH THE DEVICE DURING THE FIRST SURGERY. NOR WERE THERE ANY ALA

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6507805 ↗
• MalfunctionMar 4, 2017Failure to Cut; Failure to Cut

  GASTRIC SLEEVE - "WHILE USING THE VOYANT 5MM FUSION IN A GASTRIC SLEEVE DR. (B)(6) WAS HAVING TO REGRASP AND REACTIVATE THE BLADE TO GET A COMPLETE CUT AS JUST FIRING ENERGY AND AND ACTIVATING THE BLADE WAS LEAVING THIN TISSUE STRANDS ACROSS ABOUT 30% OF HIS INITIAL SEALS. SEAL STRENGHT DID NOT APPEAR TO BE IMPACTED." PATIENT STATUS - PATIENT STATUS NOT IMPACTED BY EXPERIENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6378802 ↗