VOYANT® 5mm Fusion Device EB010Recalls & reported problems

Summary

The FDA's MAUDE database contains 190 adverse event reports that list this exact device (DI 00607915117856), received between Feb 22, 2016 and Sep 29, 2022 — classified as 6 injuries, 184 malfunctions.

The most frequently reported specific device problem is “Output Problem” (64 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 190 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: SURGEON MENTIONED THE DEVICE WAS ACTIVATING ITS SEAL CYCLE WITHOUT HIM PRESSING THE ACTIVATION BUTTON AND AN UNRECOGNIZED SOUND WAS HEARD FROM THE DEVICE JAWS AT THE BEGINNING OF THE SURGERY. LAPAROSCOPIC TECHNICIAN SWITCHED THE VOYANT DEVICE KEY FROM ONE PORT TO THE OTHER ONE, WITHOUT RESOLVING THE MENTIONED EVENT, SHE THEN TURNED OFF THE GENERATOR AND BACK ON, BUT THE SURGEON MENTIONED IT REMAINED THE SAME. A NEW VOYANT DEVICE EB010 1445305 AND THE SURGERY WAS SUCCESSFULLY COMPLETED. PRODUCT AVAILABLE FOR RETURN. TYPE OF INTERVENTION: LAPAROSCOPIC TECHNICIAN SWITCHED THE VOYANT DEVICE KEY FROM ONE PORT TO THE OTHER ONE, WITHOUT RESOLVING THE MENTIONED EVENT, SHE THEN TURNED OFF THE GENERATOR AND BACK ON PATIENT STATUS: GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506267 ↗
• MalfunctionMar 19, 2021Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: IN THE SURGERY THEY WERE USING APPLIED MEDICAL KII Z-THREAD TROCARS AND OTHER LAPAROSCOPIC INSTRUMENTS SUCH AS LENS, ALSO A UTERINE MANIPULATOR WAS BEING USED. THE LAPAROSCOPIC TECHNICIAN ON THE CASE MENTIONS THE VOYANT DEVICE APPARENTLY WAS ACTIVATING BY ITSELF, WHEN A SEAL WAS NOT DESIRED, HENCE THEY STOPPED USING THE DEVICE. THIS DEVICE WAS OPENED ONCE ANOTHER VOYANT DEVICE FAILED. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 04MAR2021 FROM APPLIED MEDICAL SALES REPRESENTATIVE: "THE CASE WAS COMPLETED WITH THE DEVICE HAVING FAILURES." "IT [THE UNINTENDED ACTIVATION] OCCURRED SINCE THE DEVICE WAS OPENED, WITHOUT THE NEED TO ACTIVATE IT." "THIS HAPPENED DURING THE WHOLE PROCEDURE"" THE ISSUES OCCURRED "SINCE THE BEGINNING". TYPE OF INTERVENTION: THE PROCEDURE WAS COMPLETED WITH AN OPEN APPROACH, SINCE THE DEVICE WAS FAILING PATIENT STATUS: GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11532314 ↗
• MalfunctionSep 14, 2020Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: TOTAL LAPAROSCOPIC COLECTOMY. EVENT DESCRIPTION: WE WOULD LIKE TO SHARE WITH THE TEAM ONE CER OCCURRED ON (B)(6) 2020 AT [HOSPITAL] THROUGH OUR CUSTOMER. THE COMPLAINT IS ABOUT HANDPIECE OF VOYANT GENERATION I (EB010) BATCH 1365170. THE GENERATOR USE WAS THE SERIAL NUMBER (B)(4). THE PROCEDURE WAS DUE TO CANCER AT TWO DIFFERENT SITES. DURING THE PROCEDURE WAS UTILIZE LAPAROSCOPIC SURGERY INSTRUMENTS SUCH AS LENSES, INSTRUMENTS AND TROCARS, THE PATIENT SHOWS THE FOLLOWING COMORBIDITIES AT THE TIME OF SURGERY ANEMIA, CIRRHOSIS, HIGH BLOOD PRESSURE. AT THE END OF THE SURGERY, THE PATIENT'S HEALTH IS GOOD NOT INJURE OCCUR A CAUSE OF THE EB010 COMPLAINT. DR. [NAME] CAN PROVIDE US A VIDEO AS EVIDENCE OF THE FAILURE. THE EB010 IS AVAILABLE TO RETURN. THE PROCEDURE HAD BEEN GOING FOR ABOUT 1 HOUR WHEN THEY WERE PERFORMING SOME SEALS AND HAD NO SIGNS OF ENERGY OR HEAT DISSIPATION, THEY MADE ANOTHER SEAL AND THE SURGEONS NOTICED THE SAME IT WAS MAKING THE WHOLE CYCLE AND NO ALARMS WERE PRESENTED, BUT THERE WAS NO SEAL PERFORMANCE AT ALL, THEY ACTIVATED THE BLADE AND HAD SOME BLEEDINGS. THE TECHNICIAN AT THE SITE RESTARTED THE GENERATOR AND CHANGED THE DEVICE FORM PORT 1

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529135 ↗
• MalfunctionSep 2, 2020Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC HEMI-COLECTOMY RIGHTSIDE. INCIDENT DESCRIPTION: TRANSLATION AME: EB210 GIVES ERROR MESSAGE ON GENERATOR AND ACTIVATES WITHOUT PRESSING THE BUTTON. I HAVE ASKED ADDITIONAL QUESTIONS TO THE CUSTOMER. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10485390 ↗
• MalfunctionApr 8, 2020Mechanical Problem; Mechanical Problem

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: WHEN THE DR. TRY TO CUT, THE VOYANT DIDN´T CUT DURING ALL SURGERY. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 04FEB20: TOTAL LAPAROSCOPIC HYSTERECTOMY. THE SURGEON TOLD ME ABOUT 5 CUT, HE SAW THAT VOYANT DIDN´T CUT ANYTHING. HE DIDN´T TOLD ME THIS¿HE DON¿T REMEMBER¿BUT I KNOW THAT IN THIS SURGERIES THERE ARE A LOT OF CONNECTIVE TISSUE. HE TOLD ME THAT HE HAD RESISTANCE. THE VOYANT DIDN'T CUT ANYTHING. THE SURGEON DID NOT NOTICE ANY IMPROVEMENT IF/WHEN THE JAWS WERE CLEANED. THE SURGEON WAS NOT ABLE TO FIND A RESOLUTION, HE CHANGED THE HANDPIECE. PATIENT STATUS: PATIENT IS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935675 ↗
• MalfunctionDec 5, 2019Mechanical Problem; Mechanical Problem

  PROCEDURE PERFORMED: HYSTERECTOMY NON ROBOTIC. EVENT DESCRIPTION: AFTER APPROXIMATELY 5 TO 10 ACTIVATIONS AND CUTS THE BLADE BECAME STUCK WHILE CUTTING. THE SURGEON PULLED OUT THE DEVICE THROUGH THE TROCAR AND GRASPED THE BLADE LEVER AND THE BLADE STUCK OUT TO THE END OF THE JAW AND WOULD NOT RETRACT WHEN THE SURGEON SQUEEZED THE TRIGGER. THE SURGEON WAS CUTTING A FALLOPIAN TUBE WHEN HE NOTICED THE STUCK BLADE. THE DEVICE WAS REPLACED WITH A NEW APPLIED MEDICAL DEVICE AND THE CASE CONTINUED WITH NO FURTHER CONCERNS. THE DEVICE WAS NOT CLEANED PRIOR TO THE SURGEON NOTICING THE STUCK BLADE. NO PATIENT INJURY OCCURRED. THE DEVICE IS AVAILABLE FOR RETURN. THE REP WAS PRESENT FOR THE CASE. TYPE OF INTERVENTION: THE DEVICE WAS REPLACED WITH A NEW APPLIED MEDICAL DEVICE AND THE CASE CONTINUED WITH NO FURTHER CONCERNS. PATIENT STATUS: NO PATIENT INJURY OCCURRED AS A RESULT OF THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9416879 ↗
• MalfunctionSep 23, 2019Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: TAH BSO. EVENT DESCRIPTION: IT WAS USED BY ONE OF OUR NEW CONSULTANTS MR IN THEATRE 1 DOING A TAH BSO. THE DEVICE STUCK TO THE TISSUE AND WOULDN¿T OPEN BUT THERE WAS NO HARM TO THE PATIENT. UNFORTUNATELY THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL, 13 SEPTEMBER: I'VE JUST BEEN TO THE HOSPITAL AND SPOKEN TO ONE OF THE STAFF MEMBERS. THE ONLY CLARIFICATION I RECEIVED WAS, JAWS LOCKED IN ONE POSITION AND THEY WERE UNABLE TO OPEN IT. IT WASN'T DUE TO STICKY TISSUES BUT RATHER A FAULT MECHANICAL ASPECT ON THE HANDPIECE. THERE WAS ONLY ONE EVENT AND THAT'S JAWS LOCKED IN ONE POSITION, NOT NECESSARILY STICKING BUT THEY COULDN'T PULL IT AWAY FROM TISSUE. AM STILL WAITING ON THE OTHER ANSWERS AS THE STAFF WEREN'T ABLE TO REMEMBER. THEY HAVE EMAILED THE SURGEON TO GET MORE INFO. THEY HAVE APOLOGISED FOR NOT BEING ABLE TO GET ANY MORE DETAILS BUT HAVE ASSURED TO KEEP ME POSTED. WILL LET YOU KNOW AS SOON AS I GATHER MORE INFO. PATIENT STATUS: NO INJURY OCCURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9104464 ↗
• MalfunctionJul 12, 2019Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: LAP ULTRA LOW ANTERIOR RESECTION. THE COLON WAS MOBILISED AND THE IMA WAS FUSED WITH THE EB010. THE DEVICE WAS CLEANED BEFORE THIS STEP OF THE PROCEDURE. THE TECHNIQUE INVOLVED TRIPLE SEALING THRICE ADJACENTLY. THERE WERE THREE REGRASP ALARMS AMONGST THESE 9 ACTIVATIONS, AND THE SURGEON REGRASPED THE VESSEL AFTER THE SECOND AND THIRD REGRASP ALARM. AFTER THE FINAL ACTIVATION IN THE SERIES OF 9, THE TISSUE WAS TRANSECTED WITH EB010 BLADE. THE FELLOW THEN COULD NOT GET THE VOYANT JAWS OFF THE VESSEL. THE SURGEON SWAPPED POSITIONS, AND ASCERTAINED THAT THE EB010 JAWS WERE NOT STUCK TO THE TISSUE, BUT THAT THE BLADE WAS STUCK AFTER TRANSECTION. THE SURGEON USED HIS HAND TO PROGRESS THE BLADE LEVER TO ITS NORMAL POSITION, AND THE JAWS CAME AWAY FROM THE SEALED VESSEL. LATER IN THE CASE, WORKING DEEP IN THE PELVIS, THERE WAS A STUCK BUTTON ALARM, CLOSELY FOLLOWED BY A SECOND STUCK BUTTON ALARM. AFTER THE CASE THE SURGEON COMMENTED THAT A FUSE CYCLE COMPLETED WITHOUT THEIR THUMB BEING ON THE ACTIVATION BUTTON. THIS DID NOT CAUSE INJURY TO THE PATIENT. PATIENT STATUS: THIS DID NOT CAUSE INJURY TO THE PATIENT. TYPE OF INTERVENTION: UNK

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787326 ↗
• MalfunctionMay 30, 2019Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: SLEEVE GASTRECTOMY. "DURING THE SLEEVE GASTRECTOMY CASE, WHILE THE SURGEON WAS IN THE PROCESS OF STOMACH MOBILIZATION THE 5MM FUSION VOYANT DEVICE DIDN'T WORK PROPERLY. THE HANDLE GOT STUCK IN PLACE AFTER THE SURGEON GRASPED THE TISSUE EMITTING A STRANGE NOISE AND COULDN'T BE RELEASED ANYMORE. TO RESOLVE THIS ISSUE, THE SURGEON HAD TO USE ANOTHER BIPOLAR DEVICE TO SEPARATE THE STUCK TISSUE AND TO REMOVE THE VOYANT. WE HAVE THE SAMPLE DEFECTIVE, PLEASE ADVICE. NORMAL STATUS (HEALTHY PATIENT) - DOING SLEEVE GRATRECTOMY. PROCEDURE WAS COMPLETED WITH COMPETITOR DEVICE 5 MM LIGASURE CONVIDIEN. STANDARD LAPAROSCOPIC TECHNIQUE. APPLIED MEDICAL TROCAR 3( 5MM OPTICAL ), 1( 11MM OPTICAL) (15MM OPTICAL). NO PICTURES AVAILABLE, THE DEVICE IS WITH US. THANK YOU". PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH COMPLAINT EVENT. INTERVENTION: COMPETITOR DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656173 ↗
• MalfunctionMar 27, 2019Energy Output Problem; Energy Output Problem

  NAME OF PROCEDURE BEING PERFORMED: TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO OOPHORECTOMY. NEAR THE END OF THE CASE (AT 4-4.30PM GMT) THE EB010 WAS PLACED IN THE QUILL. THE CONSULTANT AND NURSE NOTICED THAT THE EB010 WAS REPEATEDLY GOING THROUGH A COMPLETE SEAL CYCLE. THE TONE CHANGED AT THE END AS IF A FULL CYCLE WAS COMPLETE AND THE BLADE COULD NOW BE ACTIVATED. I ASKED THE NURSE TO REMOVE IT FROM THE QUILL AND PLACE IT ON THE TABLE. THE PROCESS KEPT REPEATING WITH THE ERROR MESSAGE APPEARING AT THE END OF EVERY COMPLETE CYCLE "CHECK FOR A STUCK BUTTON". THE NURSE THOROUGHLY CLEANED THE DEVICE IN QUESTION INCLUDING THE JAWS AND AROUND THE ACTIVATION BUTTON ITSELF. WHEN SHE REPLACED IT ON THE TABLE OR HELD IT IN HER HAND THE CYCLE KEPT REPEATING (GOING TO FULL COMPLETION WITH THE TONE CHANGING TO CYCLE COMPLETE, AS IF YOU COULD NOW ACTIVATE THE BLADE) BUT THEN THE "CHECK FOR A STUCK BUTTON" MESSAGE APPEARED ON THE GENERATOR SCREEN. I REMOVED THE SAMPLE FROM THE CASE, ISOLATED IT, AND IT WAS NOT USED AGAIN BY THE CONSULTANT IN THE PATIENT AGAIN. NO PATIENT INJURY OCCURRED NOR DID THIS OCCUR WHILST THE DEVICE WAS WITHIN THE PATIENT HERSELF. ADDITIONAL INFORMATION RECEIVED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458506 ↗
• MalfunctionMar 21, 2019Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: COLECTOMY. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM SALES REPRESENTATIVE ON 5MAR2019: ENGLISH TEXT PROVIDED BY SALES REPRESENTATIVE: HERE THE FULL TEXT FROM DR. IN ENGLISH FOR SUBMITTING TO THE US: IT WAS A SEVERE VENOUS BLEEDING FROM THE COLICA SINSITRA / MESENTERICA INFERIOR. DURING THE WHOLE PROCEDURE THE SEALED TISSUE AND VESSELS WERE A BIT OOZING. DURING THE SEALING OF A MOBILIZED VESSEL THE VOYANT GAVE THE TONE FOR COMPLETED CYCLE, DURING CUTTING THERE OCCURED A SEVERE BLEEDING, IN THE END 500CC BLOODLOSS. DURING INSPECTION OF THE SEAL, THERE WAS NO SEAL AT ALL VISIBLE. JAWS WERE CLEAN BEFORE SEALING. THE PATIENT WAS YOUNG AND HIGH BMI. PATIENT DID NOT HAD A BLOOD TRANSFUSION AFTER THE OR BUT THE DOCTOR BELIEVES SHE WILL RECOVER NORMALLY. REMARK: THE PATIENT HAD CROHN DISEASE BEFORE BUT THIS WAS NO LONGER THE CASE AT THIS MOMENT AS THE DOCTOR EXPLAINED. AFTER TESTING AND IMPLEMENTATION THEY ARE WORKING NOW 8 MONTHS WITH THE VOYANT WITHOUT ANY COMPLAINTS. TODAY THEY WILL USE THE COMPETITOR DEVICE, BECAUSE OF A HIGH BMI PATIENTS ALSO FOR A LAR PROCEDURE. NEXT WEEK THE DOCTOR IS WILLING TO WORK WITH VOYANT AGAIN DURING A HEMI RIGHT COLECTOMY. ADDITIONAL

  Patient problems: Blood Loss

  MAUDE report 8441519 ↗
• MalfunctionJan 4, 2019Break; Break

  PROCEDURE PERFORMED: TLH TOWARDS THE END OF THE CASE DOCTOR WAS GRASPING THE CARDINAL LIGAMENT WHEN HE WENT TO CLOSE THE DEVICE, THE JAW BROKE OFF AND WAS DANGLING BY THE WIRE. 5MM TROCAR WAS BEING USED SO THE DEVICE HAD TO BE CUT AND PULLED OUT. DOCTOR REPORTED TO THE REP THAT THE PATIENT¿S ENDOMETRIAL TISSUE WASN¿T BAD. A NEW DEVICE WAS OPENED AND THE CASE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018: I AM NOT SURE I CAN REACH OUT TO THE SURGEON AND ASK FOR MORE CLARIFICATION. WHAT I WAS TOLD WAS THEY HAD TO CUT THE WIRE IN ORDER TO GET THE JAW OUT OF THE TROCAR BECAUSE THEY WERE JUST USING 5 MM TROCARS. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018: THEY DID CONFIRM THERE WERE NO ABNORMALITIES WITH THAT CASE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8218856 ↗
• MalfunctionDec 19, 2018Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: UNKNOWN. ORIGINAL: BLOCAGE DE LA POIGNÉE AU MOMENT DU GESTE ENTRAINANT UN ARRACHEMENT DES TISSUS ET DES SAIGNEMENTS. ACTION MENÉE : UTILISATION D¿UN AUTRE DISPOSITIF D¿UNE AUTRE MARQUE POUR TERMINER L¿INTERVENTION. TRANSLATION AME: THE HANDLE BLOCKED DURING THE GESTURE, ENTAILING TEARING OF TISSUE AND BLEEDING. REMEDIAL ACTIONS: USE OF ANOTHER DEVICE OF ANOTHER BRAND TO FINISH THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 27NOV2018: CURRENT PATIENT STATUS? THE PATIENT IS FINE. APPROXIMATE AMOUNT OF BLOOD LOST (IN CC OR CL)? NOT A LOT. HOW LONG HAD THE DEVICE BEEN USED BEFORE THE EXPERIENCE WAS OBSERVED (APPROX. # OF ACTIVATIONS)? 3 OR 4 ACTIVATIONS. HOW WAS THE BLEEDING RESOLVED? BY COAGULATION WITH A BI-POLAIRE. DID THE SURGEON ATTEMPT TO OPEN THE JAWS, OR DID THEY PULL THE JAWS OFF STRAIGHT AWAY? THE SURGEON TRIED TO OPEN THE JAWS BUT IT WASN¿T POSSIBLE. IN WHICH POSITION WAS THE BLADE LEVER WHEN THE INCIDENT OCCURRED? THE SURGEON DOESN¿T KNOW WHERE THE BLADE LEVER WAS BUT THE INCIDENT OCCURRED AFTER THE COAGULATION. WHAT TISSUE TYPE DID THE JAWS STAY CLOSED ON? ON THE ROUND LIGAMENT. ADDITIONAL INFORMATION RECEIVED 14DEC2018: THE SURGEON PULLED ON THE JAWS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182783 ↗
• InjuryDec 12, 2018Energy Output Problem; Energy Output Problem

  DATE OF INCIDENT IS UNKNOWN. FOLLOWING A MEETING WITH THEATRE MANAGER, ON 9TH NOVEMBER 18, I WAS INFORMED THAT THE PATIENT FROM PREVIOUS INCIDENT WAS RETURNED TO THEATRE FOLLOWING PROCEDURE ON (B)(6) 2018. THIS WAS RECORDED VIA DATIX. THEATRE MANAGER DID NOT PROVIDE FURTHER DETAILS WHEN ASKED REGARDING CIRCUMSTANCES OF PATIENTS RETURN TO THEATRE. PATIENT STATUS IS UNKNOWN ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT AS OF TODAY, 19 NOVEMBER, IT WAS NOT POSSIBLE TO GATHER MORE. CLARIFICATION FROM REP RECEIVED 17DEC2018: THE ANSWER TO YOUR QUESTION; ACCORDING TO THE INFORMATION GIVEN TO ME BY THE THEATRE MANAGER, ON THE 8TH NOVEMBER 2018. FOLLOWING THE PROCEDURE ON (B)(6) 2018, THAT PATIENT RETURNED BACK TO THEATRE SOON AFTER (I DON¿T KNOW THE DATE) FOR AN UNSPECIFIED REASON. THEATRE MANAGER TOLD ME THAT HE HAD HEARD A COMMENT FROM HOSPITAL REP THAT IMPLIED IT WAS DUE TO THE VOYANT. BECAUSE OF THIS COMMENT, I SUBMITTED A CER TO REPORT THE ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 8158381 ↗
• MalfunctionOct 8, 2018Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  PROCEDURE PERFORMED: LAVH. THE DEVICE WORKED FINE IN THE BEGINNING. IT GRADUALLY STARTED TO STOP CUTTING, BUT WAS STILL ABLE TO FUSE. REP WAS NOT IN SURGERY AT THE TIME, BUT SPOKE TO DOCTOR AFTER THE SURGERY AND WENT OVER THE PROCESS, INCLUDING CLEANING OF JAWS. DOCTOR WAS AWARE AS HE HAS USED THE DEVICE MANY TIMES. HE DID SAY THAT THE DEVICE FELT FUNNY OUT OF THE BOX. TYPE OF TISSUE BEING CUT WHEN POOR CUTTING PERFORMANCE WAS NOTICED IS UNKNOWN. WHERE ALONG THE JAW WAS THE BLADE NOT CUTTING? IT WASN'T CUTTING AT ALL. PATIENT STATUS: FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7945201 ↗
• MalfunctionJul 31, 2018Defective Component; Mechanical Jam; Defective Component; Mechanical Jam

  PROCEDURE PERFORMED: TOTAL LAPAROSCOPIC HYSTERECTOMY. "DR OBSERVED THAT DEVICE CLOSED ON TISSUE BUNDLE BUT HEARD AND FELT A CRUNCHING SOUND AND SENSATION COMING FROM HANDLE OF DEVICE. EB010 WENT THROUGH FULL SEAL CYCLE AND WAS ABLE TO BE UNLOCKED WITH SOME DIFFICULTY ( RESISTANCE ) BUT DID INDEED OPEN AND FREE FROM TISSUE THAT HE HAD SEALED AND TRANSECTED. DR CONTINUED TO USE DEVICE THROUGH 2 SEAL CYCLES BUT FOUND HE COULD NOT GET HANDLE TO LOCK ON TISSUE AND ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. AS SURGEON IS STILL OPERATING ON NEXT CASE I WILL BE IN TOUCH LATER THIS AFTERNOON TO ASSESS APPROXIMATE NUMBER OF ACTIVATIONS AND WHERE HE WAS ANATOMICALLY WHEN PROBLEMS WITH HANDLE ENCOUNTERED. DR IS A GYNAECOLOGICAL ONCOLOGIST AND VERY EXPERIENCED WITH THE VOYANT IES". FURTHER INFORMATION RECEIVED THURSDAY 5 JULY AT 11.59AM BY REP: "I SPENT A LITTLE MORE TIME WITH DR YESTERDAY AFTERNOON AND WAS ABLE TO GET A LITTLE BIT MORE INFORMATION FROM THE SURGEON AFTER THE DUST HAD SETTLED. THE PATIENT DID HAVE A SIGNIFICANT HISTORY OF ENDOMETRIOSIS WHICH MADE FOR A VERY DIFFICULT DISSECTION. THE OPERATION WAS BEING PERFORMED FOR A UTERINE CANCER. DR WAS WELL INTO THE PROCEDURE AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736493 ↗
• MalfunctionJul 17, 2018Defective Component; Mechanical Jam; Defective Component; Mechanical Jam

  PROCEDURE PERFORMED: SIGMOID RESECTION. DURING THE INTERVENTION, AFTER HAVING ALREADY MADE 14 SHOTS OF THE VOYANT 5MM FUSION CLAMP, THE HANDLE REMAINED STUCK. THE SURGEON CLOSED THE JAWS BY PRESSING THE HANDLE, DELIVERED THE ENERGY TO SEAL THE TISSUE, PASSED THE BLADE AND CUT THE TISSUE, BUT AT THE TIME OF OPENING THE HANDLE TO OPEN THE JAWS WAS RUN AGROUND. THE SURGEON HAD TO FINISH THE SURGERY WITH ANOTHER CLAMP. AFTER TRYING TO UNCLOG THE CLAMP, JUMP THE SMALL METAL PIECE THAT ALLOWS THE HANDLE TO CLOSE AND OPEN. THIS PIECE WAS HOOKED TO THE HANDLE WITH ADHESIVE TAPE SO THAT THERE IS PROOF OF WHICH PIECE IT IS. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE BY EMAIL ON 06/18/2018: THE BLADE DID NOT GET STUCK. WHAT GOT STUCK WAS THE HANDLE. THE SURGEON WAS ABLE TO RELEASE THE JAWS FROM THE TISSUE AFTER ENERGY DELIVERY AND TISSUE TRANSECTION. THE TISSUE WAS REMOVED WELL, WITHOUT TISSUE DAMAGE OR BLEEDING. THE SURGEON FOUND A RESOLUTION BY CHANGING THE DEVICE. THE HOSPITAL WAREHOUSE KEPT THE SAMPLE SO THAT WE CAN PICK IT UP. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695820 ↗
• MalfunctionJun 5, 2018Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAP. HYSTERECTOMY DEVICE WORKED WELL ( GOOD SEALING) , SURGEON WAS SATISFIED, EXCEPT FOR MANIABILITY AND ERGONOMY. SHE WAS A BIT STRESSED AND PROBABLY PRESSED THE HANDLE TOO STRONGLY SINCE THE BEGINNING. AT A TIME, THE JAWS KEPT CLOSED ON TISSUE. 5-6 TRIES BEFORE IT OPENS AGAIN. NO INJURY TO THE PATIENT. ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7571911 ↗
• MalfunctionMay 31, 2018Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: TOTAL LAPAROSCOPIC HYSTERECTOMY. TWO SURGEONS PERFORMED THE PROCEDURE. THE FIRST SURGEON USED THE EB010 IN THE FIRST HALF OF THE PROCEDURE WITHOUT ISSUES. THE SECOND SURGEON PLACED TENSION ON TISSUE DURING THE SEAL CYCLE, AND BLEEDING OCCURRED AFTER THE JAWS OPENED AND TENSION WAS RELEASED. IT APPEARED THAT ESCHAR BUILT UP IN THE JAWS DUE TO STOPPING THE BLEEDING. THE JAWS BECAME STUCK IN THE CLOSED POSITION AND THE SURGEON HAD TO FORCE THE HANDLE OPEN TO RELEASE THE TISSUE. A NEW EB010 WAS OPENED AND THE FIRST SURGEON FINISHED THE PROCEDURE WITHOUT ISSUES. THERE WAS NO PATIENT INJURY. REP STATED HE WAS IN THE PROCEDURE. THE BLADE LEVER WAS NOT BEING USED AT THE TIME THE HANDLE BECAME STUCK IN THE CLOSED POSITION, IT WAS ONLY BEING USED TO SEAL TO STOP THE BLEEDING. THE JAWS BECAME STUCK JUST ONE TIME. THE DEVICE WAS BEING USED UNDER 50 ACTIVATIONS APPROXIMATELY. ACTIVATION ERRORS WILL APPEAR ON THE DEVICE KEY AS THE SURGEON STATED HE TAPPED THE ACTIVATION BUTTON INTENTIONALLY WITHOUT COMPLETING THE SEAL CYCLE AS A TECHNIQUE FOR USING THE DEVICE ON NON-VASCULAR TISSUE. THE TISSUE WAS NOT STICKING. THE HANDLE ONLY BECAME STUCK ONCE AND WAS FORCED OPEN BEFORE IT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7557257 ↗
• MalfunctionMay 29, 2018Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: UNKNOWN. THE DEVICE FUSION 5MM WORKED WELL FOR ABOUT 2 HOURS, BUT THE JAWS REMAINED STUCK. AFTER SEVERAL ATTEMPTS, THE JAWS WERE ABLE TO REOPEN. THE SURGEON ASKED FOR A NEW DEVICE, WHICH WORKED WELL (INCIDENT REPORT DOCUMENT) THERE WAS NO DECLARATION TO (B)(6). ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY EMAIL ON 23-APRIL-2018: IT IS UNKNOWN WHETHER THE BLADE LEVER WAS NOT RETURNING TO THE FORWARD POSITION WHEN RELEASED. THE SURGEON WAS ABLE TO RELEASE THE JAWS FROM THE TISSUE AFTER SEVERAL ATTEMPTS BY OPENING THE DEVICE WITH BOTH HANDS. THERE WAS NO DAMAGE ON THE TISSUE. THIS OCCURRED ONE TIME, WITH NECESSITY TO CHANGE DEVICE. THIS WAS OBSERVED BETWEEN 2 AND 4 HOURS OF USAGE, NUMBER OF ACTIVATIONS UNKNOWN. THE DATE OF INCIDENT IS (B)(6) 2017. THE JAWS OF THE DEVICE WERE CLEANED DURING THE PROCEDURE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. NO CONSEQUENCE ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7549441 ↗
• MalfunctionApr 5, 2018Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPY. HOSPITAL FILE NUMBER; (B)(4). THE DEVICE DID NOT WANT TO OPEN ANYMORE DURING A LAPAROSCOPY. BLOCKED IN CLOSED POSITION. NON-FUNCTIONAL BLADE AS WELL. REOPENS ONCE REMOVED FROM THE ABDOMEN. RISK OF TEARING ISSUE WITH BLEEDING. PATIENT STATUS: CLINICAL CONSEQUENCES: NONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7399468 ↗
• MalfunctionMar 8, 2018Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: TOTAL LAPAROSCOPIC HYSTERECTOMY. FIRST EVALUATION CASE WIT DR (OBGYN) OF VOYANT EB010. PRODUCT HAD BEEN CORRECTLY IN SERVICED PRIOR TO CASE. APPROXIMATELY 15 ACTIVATIONS INTO PROCEDURE THE SPRING LOADED HANDLE WOULD NOT RELEASE IMMEDIATELY AFTER ACTIVATION AND TRANSACTION. I WAS APPROXIMATELY 2 METERS FROM THE INCIDENT AND HAD A PERFECT VIEW - TO THIS POINT THE DEVICE WAS WORKING EXACTLY AS EXPECTED YET ON THIS CYCLE THE PATIENTS TISSUE BUNDLE REMAINED GRASPED BETWEEN THE JAWS. ASSESSMENT IS THAT THE SPRING HANDLE FAILED. THIS INCIDENT REQUIRED THE SURGEON TO USE SCISSORS TO EXTRACT THE TISSUE - A REPLACEMENT VOYANT EB010 FROM THE SAME BATCH WAS OPENED THE CASE PROCEEDED WITHOUT INCIDENT. SURGEON COMMENTED POSITIVELY ON THE DEVICE FUNCTIONALITY BUT THE INCIDENT CAUSED SOME UNDERSTANDABLE CONCERN. ADDITIONAL INFO RECEIVED FROM APPLIED MEDICAL TEAM MEMBER, (B)(6): DR WAS TAKING DOWN THE IP LIGAMENT WHEN THE EVENT OCCURRED. PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO. PATIENT STATUS (WHAT HAPPENED AS A RESULT OF THIS EVENT?): SHORT DELAY TO PROGRESS. REPLACEMENT OPENED & CASE PROCEEDED WITHOUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7325975 ↗
• MalfunctionMar 5, 2018Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: "LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY." "LOCKING MECHANISM ON HANDLE WASN'T WORKING." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM TERRITORY MANAGER, ON FRIDAY 9FEB2018 AT 9:44 AM "LOCKING MECHANISM ON DEVICE WAS MALFUNCTIONING. THE BLADE LEVER WAS NOT STILL ENGAGED WHEN SURGEON WAS ATTEMPTING TO UNLATCH IT. AFTER GETTING IT UNLATCHED, THE DOCTOR WAS THEN UNABLE TO LOCK THE HANDLE MOVE FORWARD. IT WAS USED FOR APPROX 6-7 ACTIVATIONS BEFORE THEY OPENED ANOTHER EB010. THE REMAINDER OF THE SURGERY WAS PERFORMED SUCCESSFULLY WITH THE SECOND DEVICE. PATIENT IS OK." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM TERRITORY MANAGER ON TUESDAY 13FEB2018 AT 9:15 AM. "CORRECT, THE AWARENESS DATE AND THE INCIDENT DATE ARE (B)(6) 2018." PATIENT STATUS: "PATIENT IS OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7313671 ↗
• MalfunctionFeb 14, 2018Output Problem; Output Problem

  PROCEDURE PERFORMED: ADNEXA REMOVAL / SALPINGO-OOPHOR. INCIDENT DESCRIPTION: "HAS SOME DOUBTS ABOUT THE HEMOSTASIS OF THE VOYANT. SAID HE PERFORMED A TLH ON THE 14TH AND THAT THERE WAS A LOT OF BLOODLOSS. DURING THIS PROCEDURE, THERE WAS AT ONE POINT A BLEEDING AS WELL. IT WAS HARD TO CONCLUDE WHETHER IT WAS THE CAUSE OF THE DEVICE." PATIENT STATUS: NI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7272162 ↗
• MalfunctionFeb 6, 2018Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: NEPHRECTOMY. WHEN USING THE VOYANT DEVICE DURING A NEPHRECTOMY BY LAPAROSCOPY, THE DEVICE GOT BLOCKED IN THE CLOSED POSITION, MAKING ITS USE IMPOSSIBLE DEVICE DECONTAMINATED AND SENT TO THE PHARMACY FOR EXPERTISE WITH THE LABORATORY. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM THE SALES REP ON 25 JAN 2018: I DIDN'T SEE THE SURGEON FOR THE MOMENT, BUT A NURSE TOLD ME THAT THE DEVICE WAS LOCKED ON TISSUE (AFTER THE FUSION)... PATIENT STATUS: NI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7246110 ↗