VOYANT® Maryland Fusion Device EB215Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00607915139353), received between Jul 8, 2019 and Sep 8, 2026 — classified as 16 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (23 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 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672177 ↗
• MalfunctionAug 14, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258911 ↗
• MalfunctionJul 28, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063698 ↗
• MalfunctionMar 16, 2026Failure to Seal

  PROCEDURE PERFORMED: LAPAROSCOPIC SALPINGECTOMY. EVENT DESCRIPTION: THE DOCTOR WAS PERFORMING A LAPAROSCOPIC SALPINGECTOMY. THE DEVICE WAS PLUGGED IN AND THE VOYANT GENERATOR SAID DEVICE READY. IT MADE THE SOUND OF BURNING BUT NO HEAT WAS APPLIED TO THE TISSUE. WHEN THE DR CUT THE TISSUE HE COULD SEE THAT NO THERE WAS NO BURNING OF THE TISSUE AND IT WAS BLEEDING. INFORMATION FROM DISTRIBUTOR FORM: THE DEVICE WAS PLUGGED IN AND THE VOYANT GENERATOR SAID DEVICE READY. IT MADE THE SOUND OF BURNING BUT NO HEAT WAS APPLIED TO THE TISSUE. WHEN THE DR CUT THE TISSUE, HE COULD SEE THAT NO THERE WAS NO BURNING OF THE TISSUE AND IT WAS BLEEDING. ADDITIONAL INFORMATION RECEIVED BY DISTRIBUTOR VIA EMAIL ON 10-MAR-26: THE BLEEDING WAS OBSERVED 1-2 SECONDS, 2 ACTIVATIONS AFTER THE JAWS WERE REMOVED. THE BLEEDING WAS REMOVED USING ANOTHER VOYANT. THE FALLOPIAN TUBES WERE BEING SEALED. THE BLEEDING WAS NOT OBSERVED FROM A SPECIFIC VESSEL SEAL. GENERAL OOZING OBSERVED AROUND A TISSUE BUNDLE. NO VASCULAR PATHOLOGY. TENSION WAS APPLIED, FALLOPIAN TUBES WERE BEING HELD WITH A SOFT GRASPER. NO ESCHAR BUILDUP. THE JAWS WERE NOT CLEANED. NO ALARMS. THE "SOUND OF BURNING" IS THE SHORT PEEP PEEP PEEP SOUND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613148 ↗
• MalfunctionMar 2, 2026Failure to Seal

  PROCEDURE PERFORMED: LAPROSCOPIC SALPINGECTOMY, ADESIOLYSIS, CYSTECTOMY. EVENT DESCRIPTION: DURING A GYNAE LAPAROSCOPIC PROCEDURE, WHEN TRYING TO ACTIVATE THE DEVICE NO ACTION WAS RENDERED. NO BURNING. VOYANT GENERATOR DID NOT SHOW ANY ERROR CODES EITHER. [SURGEON NAME REDACTED] WAS DOING A LAP CASE ON A PATIENT, STAFF OPENED THE DEVICE AND PLUGGED IT INTO THE GENERATOR AS PER USUAL. NO ERROR CODES DISPLAYED. DISPLAY READ READY. BUT WHEN THE SURGEON TRIED ACTIVATING THE DEVICE BY PRESSING THE ACTIVATION BUTTON NOTHING WAS BURNING, NO SMOKE, NO BURN, TRIED A FEW TIMES AND OPENED THE DEVICE AND REAPPLIED TO SMALLER AMOUNT OF TISSUE AND STILL NO BURN. THE STAFF THEN CONTACTED ME AND ADVISED ON THE SITUATION AND I SAID THEY COULD THEN OPEN A NEW DEVICE. THEY TRIED A SECOND DEVICE AND THE SAME THING HAPPENED. BUT THEY CHARGED THE PATIENT FOR THIS ONE. HAD THE SAME LOT NUMBER AS THE FIRST DEVICE. WAS A VERY SICK PATIENT WHO WAS BLEEDING, SO SURGEON REVERTED TO AN OPEN PROCEDURE. I DID ADVISE THE STAFF MEMBER TO PLEASE KEEP ME THE FAULTY DEVICE SO I COULD SEND IT FOR PRODUCT COMPLAINT. I ALSO SPOKE TO THE STOCK CONTROLLER AND ASKED HIM TO PLEASE ADVISE THE STAFF TO KEEP THE DEVICE. BUT WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491516 ↗
• MalfunctionFeb 26, 2026Failure to Seal

  PROCEDURE PERFORMED: LAPAROSCOPIC GASTRIC SLEEVE EVENT DESCRIPTION: [HOSPITAL NAME] DESCRIPTION RECEIVED FROM THE FIELD TEAM MEMBER ON (B)(6) 2026: "THE SURGEON REPORTED THAT WHILE USING THE DEVICE INTRAOPERATIVELY, IT UNEXPECTEDLY STOPPED SEALING TISSUE/VESSELS EVEN THOUGH HE WAS PRESSING THE ACTIVATION BUTTON AND THERE WAS A SOUND FROM THE GENERATOR; HOWEVER, NO SEALING OR CUTTING EFFECT WAS ACHIEVED." DESCRIPTION REPORTED BY SFDA BY EMAIL ON FEBRUARY 25, 2026: "THE DEVICE IS DESIGNED TO CAUTERIZE AND CUT AT THE SAME TIME; HOWEVER, IT NEITHER CAUTERIZES NOR CUTS." INTERVENTION: USED ANOTHER COMPETITOR DEVICE. PATIENT STATUS: NO INJURY OR ILLNESS.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462431 ↗
• MalfunctionFeb 11, 2026Failure to Seal

  PROCEDURE PERFORMED: LAPRASCOPIC SALPINGECTOMY, ADESIOLYSIS,CYSTECTOMY. EVENT DESCRIPTION: DURING A GYNAE LAPRASCOPIC PROCEDURE, WHEN TRYING TO ACTIVATE THE DEVICE NO ACTION WAS RENDERED. NO BURNING. VOYANT GENERATOR DID NOT SHOW ANY ERROR CODES EITHER. [SURGEON NAME REDACTED] WAS DOING A LAP CASE ON A PATIENT, STAFF OPENED THE DEVICE AND PLUGGED IT INTO THE GENERATOR AS PER USUAL. NO ERROR CODES DISPLAYED. DISPLAY READ READY. BUT WHEN THE SURGEON TRIED ACTIVATING THE DEVICE BY PRESSING THE ACTIVATION BUTTON NOTHING WAS BURNING, NO SMOKE, NO BURN, TRIED A FEW TIMES AND OPENED THE DEVICE AND REAPPLIED TO SMALLER AMOUNT OF TISSUE AND STILL NO BURN. THE STAFF THEN CONTACTED ME AND ADVISED ON THE SITUATION AND I SAID THEY COULD THEN OPEN A NEW DEVICE. THEY TRIED A SECOND DEVICE AND THE SAME THING HAPPENED. BUT THEY CHARGED THE PATIENT FOR THIS ONE. HAD THE SAME LOT NUMBER AS THE FIRST DEVICE. WAS A VERY SICK PATIENT WHO WAS BLEEDING, SO SURGEON REVERTED TO AN OPEN PROCEDURE. I DID ADVISE THE STAFF MEMBER TO PLEASE KEEP ME THE FAULTY DEVICE SO I COULD SEND IT FOR PRODUCT COMPLAINT. I ALSO SPOKE TO THE STOCK CONTROLLER AND ASKED HIM TO PLEASE ADVISE THE STAFF TO KEEP THE DEVICE. BUT WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318692 ↗
• MalfunctionNov 13, 2025Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: CUT OF BLOOD VESSELS. EVENT DESCRIPTION: SITUATION: ONCE THE FORCEPS WERE IN USE, THEY ACTIVATED AUTOMATICALLY WITHOUT PRESSING THE ENERGY ACTIVATION BUTTON, POSING A RISK OF INJURY TO STRUCTURES WITHIN THE CAVITY. THE FORCEPS WERE REPLACED WITH ANOTHER BRAND. SAMPLE BE ABLE FOR ANALYSIS: NO. PATIENT HARM: NO. ADDITIONAL INFORMATION PROVIDED ON 18NOV2025 VIA EMAIL: HI [APPLIED MEDICAL TM], THAT IS RIGHT. THE EVENT DATE WAS ON JUNE 14, 2025. INTERVENTION: THE FORCEPS WERE REPLACED WITH ANOTHER BRAND. PATIENT STATUS: NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543416 ↗
• MalfunctionOct 21, 2025Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: VNOTES HYSTERECTOMY. EVENT DESCRIPTION: THE DEVICE LOCKED UP DURING THE PROCEDURE. THE BLADE LEVER GOT STUCK AND IT WASN'T ABLE TO OPEN AGAIN. IT LOCKED IN A CLOSED POSITION. THE ACCOUNT MANAGER, WAS PRESENT IN THE CASE. ADDITIONAL INFORMATION PROVIDED BY [ACCOUNT MANAGER]: SURGEON WAS CUTTING AROUND ROUND LIGAMENT OF UTERUS. NO VASCULAR PATHOLOGY WAS EXHIBITED, AND TISSUE DID NOT APPEAR DISEASED OR INFLAMED. THE BLADE ONLY BECAME STUCK ONCE WHEN THE JAWS WERE UNABLE TO OPEN AGAIN. DEVICE HAD BEEN USED FOR APPROXIMATELY 15 MINUTES AND 15-20 ACTIVATIONS. THE JAWS WERE NOT CLEANED BEFORE BECOMING STUCK. THE JAWS WERE NOT CLEANED. THE ACCOUNT IS REQUESTING A REPLACEMENT. NO CHARGE PO# PENDING. ADDITIONAL INFORMATION PROVIDED BY 03OCT2025: THE JAWS WERE NOT LOCKED ONTO TISSUE, AFTER APPLYING ENERGY AND TRANSECTING THE TISSUE THE JAWS DID NOT REOPEN. THE ISSUE WAS NOT ABLE TO BE RESOLVED, AND THE DEVICE HAD TO BE REPLACED. ADDITIONAL INFORMATION OBTAINED FROM ACCOUNT MANAGER VIA EMAIL ON 13OCT2025: 1. CAN YOU PLEASE VERIFY IF REMOVING THE JAW FROM THE TISSUE RESULTED IN ANY DAMAGE? REMOVING THE JAWS DID NOT CAUSE DAMAGE TO ANY TISSUE. 2. HOW WERE THEY ABLE TO REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353115 ↗
• MalfunctionOct 15, 2025Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: HEMICOLECTOMY. EVENT DESCRIPTION: THE DEVICE MALFUNCTIONED TOWARDS THE END OF THE OPERATION. IT WORKED WELL FOR THE FIRST FEW HOURS OF THE OPERATION. THE SURGEON SIMPLY CLOSED THE HANDLE AND WAS UNABLE TO REOPEN IT. I TESTED THE DEVICE MYSELF TODAY AND I COULD NOT OPEN THE HANDLE EITHER. IT IS COMPLETLY STUCK. THE OTHER DEVICES OF THE SAME LOT ARE WORKING PROPERLY. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 22SEP25: IT IS UNKNOWN WHAT CAUSED THE JAWS TO BE LOCKED CLOSED. THE SURGEON JUST USED THE DEVICE PLASTIC TO PLASTIC AND WAS UNABLE TO OPEN IT AGAIN. NO AUDIBLE OR VISUAL DAMAGE TO THE DEVICE PRIOR TO THE INCIDENT. THE HANDLE LEVER ITSELF WAS COMPLETELY STUCK. NOT JUST THE JAWS. THEY CUT THE TISSUE AND WERE ABLE TO REMOVE THE DEVICE WITH LOCKED JAWS/HANDLE. THERE WAS SOME MINOR TISSUE DAMAGE. IT WAS OBSERVED ONCE BECAUSE THEY WERE UNABLE TO OPEN THE JAWS/HANDLE. THEY HAD TO USE ANOTHER DIVE AFTERWARDS. IT HAD BEEN USED FOR SEVERAL HOURS ALREADY. I WOULD GUESS A FEW HUNDREDS. IT DIDN´T UNLATCH. THEY COULDN´T OPEN THE JAWS. INVESTIGATION: DEVICE REPLACEMENT. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296576 ↗
• MalfunctionAug 29, 2025Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE EVENT DATE IS UNKNOWN. THE CONTACT PERSON WAS NOT PERSONALLY INVOLVED IN THE INCIDENT. FOUND THE PRODUCT ON HIS DESK WHEN HE RETURNED FROM VACATION WITH A HANDWRITTEN NOTE THAT THE PRODUCT HAD SELF-ACTIVATED DURING USE. THE CONTACT PERSON DID NOT KNOW WHO WAS INVOLVED IN THE INCIDENT. HE ALSO DID NOT KNOW THE DATE OF THE EVENT BUT WOULD TRY TO FIND THIS OUT. THE PRODUCT ITSELF AND THE PACKAGING FOR THE INSTRUMENT HAVE BEEN SAVED AND CAN BE SENT BACK TO APPLIED FOR INVESTIGATION. APPLIED MEDICAL REP'S RESPONSE RECEIVED VIA EMAIL ON 2SEP25: I HAVE SPOKEN TO THE CONTACT PERSON SEVERAL TIMES WITHOUT HIM HAVING FURTHER INFORMATION REGARDING THE CASE (HE FINDS IT VERY DIFFICULT TO FIND OUT WHO WAS PRESENT DURING THE INCIDENT AS THIS HAPPENED WHILE HE WAS ON HOLIDAY). PATIENT STATUS: NO PATIENT INJURY WAS INDICATED. INTERVENTION: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923889 ↗
• MalfunctionAug 1, 2025Output below Specifications; Output below Specifications

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: EVENT DATE IS UNKNOWN. AI TRANSLATION: COULD YOU PLEASE SEND US A GENERATOR THAT IS READY FOR USE ASAP FOR TOMORROW? WE HAVE A GENERATOR THAT IS NOT WORKING, AND TODAY WE HAD TO USE THE SECOND ONE ON SITE, BUT ACCORDING TO THE OPERATING ROOM, IT IS NOT WORKING PROPERLY. TOMORROW WE NEED GENERATORS FOR SEVERAL OPERATIONS AT THE SAME TIME. [ORIGINAL FRENCH TEXT] ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17JUN25: THERE WAS NO ERROR MESSAGE ON THE SCREEN, END-OF-ACTIVATION SOUND AND "READY" MESSAGE ON THE GENERATOR EVEN THOUGH THE TISSUES HAD NOT FUSED AT ALL. SERIAL NUMBER WAS CONFIRMED [NUMBER]. AT THE BEGINNING OF THE INTERVENTION, FUSION WAS WEAK. THEN THERE WAS NO MORE FUSION AT ALL, EVEN IF NO ERROR MESSAGE ON THE GENERATOR. SWITCHING OFF THE GENERATOR CHANGED NOTHING. THEY TRIED TO CONNECT THE CLAMP TO ANOTHER LED GENERATOR AND IT FUSED, BUT ONLY SLIGHTLY. TM WAS PRESENT WITH THE HEALTHCARE USER AND IT WAS STATED BY ANOTHER SURGEON HE HAD THE SAME PROBLEM LAST WEEK WITH ANOTHER EB215 HANDPIECE [DISCARDED], FINDING THE FUSION UNSATISFACTORY BUT HAD NOT REPORTED IT. TYPE OF INTERVENTION: NI PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690288 ↗
• MalfunctionAug 1, 2025Energy Output Problem; Output below Specifications; Energy Output Problem; Output below Specifications

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: AI TRANSLATION: COULD YOU PLEASE SEND US A GENERATOR THAT IS READY FOR USE ASAP FOR TOMORROW? WE HAVE A GENERATOR THAT IS NOT WORKING, AND TODAY WE HAD TO USE THE SECOND ONE ON SITE, BUT ACCORDING TO THE OPERATING ROOM, IT IS NOT WORKING PROPERLY. TOMORROW WE NEED GENERATORS FOR SEVERAL OPERATIONS AT THE SAME TIME. ORIGINAL: POURRIEZ-VOUS SVP NOUS FAIRE PARVENIR UN GÉNÉRATEUR VOYANT DE PRÊT EN URGENCE POUR DEMAIN ?NOUS AVONS UN GÉNÉRATEUR QUI NE FONCTIONNE PAS ET AUJOURD¿HUI NOUS AVONS DÛ NOUS SERVIR DU DEUXIÈME PRÉSENT SUR SITE, MAIS QUI DIXIT LE BLOC OPÉRATOIRE NE FONCTIONNERAIT PAS CORRECTEMENT.DEMAIN NOUS AVONS BESOIN DE GÉNÉRATEURS POUR PLUSIEURS OPÉRATIONS EN MÊME TEMPS. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17JUN25: THERE WAS NO ERROR MESSAGE ON THE SCREEN, END-OF-ACTIVATION SOUND AND "READY" MESSAGE ON THE GENERATOR EVEN THOUGH THE TISSUES HAD NOT FUSED AT ALL. SERIAL NUMBER WAS CONFIRMED (B)(6). AT THE BEGINNING OF THE INTERVENTION, FUSION WAS WEAK. THEN THERE WAS NO MORE FUSION AT ALL, EVEN IF NO ERROR MESSAGE ON THE GENERATOR. SWITCHING OFF THE GENERATOR CHANGED NOTHING. THEY TRIED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689425 ↗
• MalfunctionJul 2, 2025Self-Activation or Keying; Self-Activation or Keying

  TYPE OF PROCEDURE PERFORMED: VNOTES HYSTERECTOMY. EVENT DESCRIPTION: AFTER ABOUT 10 MINUTES USE OF VOYANT DURING THE LAPAROSCOPIC PHASE. VOYANT STARTED TO MALFUNCTION. DID NOT ACTIVATE WHEN ENERGY BUTTON WAS PUSHED. INSTEAD ACTIVATED WHEN LATCHING HANDLE WAS COMPRESSED. UNDOCKED THE VOYANT DEVICE KEY BUT DID NOT WORK. RESTARTED THE GENERATOR. DID NOT WORK. REPLACED THE HANDPIECE WITH A NEW EB215. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 18JUN2025: LOT NUMBER ON THE KIT GK770 (THIS IS A EB215 THAT WAS INCLUDED IN THE KIT) IS: 1557878. LOT NUMBER ON THE VOYANT IS: 1543385. THEY HEARD THE ACTIVATION AND END TONE. THE SURGEON ACTIVATED THE BLADE AFTER THE END TONE. THERE WAS NO BLEEDING FROM THE INCIDENT. PATIENT STATUS: PATIENT IS WELL. NO HARM DONE BY INCIDENT. INTERVENTION: DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385942 ↗
• MalfunctionJun 13, 2025Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: THE SURGEON USED A VOYANT EB215. HE WENT TO GRAB THE FUNDUS OF THE UTERUS AND SQUEEZED ALL THE WAY DOWN. IT SOUNDED LIKE SOMETHING SNAPPED. THE JAWS WERE UNABLE TO BE OPENED. THEY REPLACED THE DEVICE WITH A NEW ONE. ADDITIONAL INFORMATION PROVIDED ON 28MAY2025: THE DOC MENTIONED THAT IS WAS MAINLY SQUEEZING DOWN ON A BIG BITE OF UTERUS WHEN THEY HEARD IT ¿SNAP¿. THAT IS WHEN IT LOCKED UP. THE JAWS WERE UNRESPONSIVE AFTER THAT. THEY USED A GRASPER TO GENTLY SLIDE IT OFF OF THE TISSUE. IT WAS TOWARD THE BEGINNING OF THE CASE. INTERVENTION: THEY REPLACED IT WITH A NEW DEVICE. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203713 ↗
• MalfunctionJun 10, 2025Mechanical Jam; Mechanical Jam

  TYPE OF PROCEDURE: GYNECOLOGY. EVENT DESCRIPTION: DURING THE SURGERY THE CLAMP REMAINED CLOSED. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 18MAR25: NO AUDIBLE NOISE & VISUAL DAMAGE. THE BLADE LEVER WAS NOT ABLE TO SPRING BACK INTO POSITION/RETURN TO POSITION AUTOMATICALLY. THE JAWS WERE NOT LOCKED ONTO TISSUE. NO TISSUE BLEEDING. THE INCIDENT WAS OBSERVED ONCE. THE DEVICE HAD BEEN USED FOR 1 OR 2 ACTIVATIONS. PATIENT STATUS: NO IMPACT. INTERVENTION: DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180361 ↗
• MalfunctionMay 28, 2025Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: GASTRIC SLEEVE EVENT DESCRIPTION: THE VOYANT INSTRUMENT DID NOT START SEALING IMMEDIATELY, BUT OFTEN ONLY AFTER THE ACTIVATION BUTTON HAD BEEN PRESSED TWO OR THREE TIMES. ON TWO OCCASIONS OBSERVED, THE DEVICE STARTED SEALING WITHOUT TOUCHING THE ACTIVATION BUTTON (FORTUNATELY FREELY IN THE ABDOMINAL CAVITY) WHEN THE JAWS WERE OPEN. AFTER THAT, THE CUSTOMER DECIDED TO CHANGE THE INSTRUMENT AND COULD FINISH THE SURGERY WITH THE NEW INSTRUMENT WITHOUT MALFUNCTION. PATIENT STATUS: NO HARM TO THE PATIENT. INTERVENTION: DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099338 ↗
• MalfunctionApr 1, 2025Device Alarm System; Device Alarm System

  PROCEDURE PERFORMED: LAPAROSCOPIC EXCISION OF OVARIAN CYST. EVENT DESCRIPTION: THE COMPLAINT WAS GENERATED FROM MEDSUN # (B)(4). VOYANT EB215 UNRECOGNIZED BY CONSOLE. INTERVENTION: NI. PATIENT STATUS: BEFORE USE, NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746702 ↗
• MalfunctionFeb 20, 2025Self-Activation or Keying; Self-Activation or Keying

  TYPE OF PROCEDURE: HYSTEROTOMY. EVENT DESCRIPTION: THE ENERGY WAS SUPPOSED TO BE ACTIVATED, BUT THE CLAMP WAS SUPPLYING ENERGY ON ITS OWN WITHOUT THE DOCTOR PRESSING THE BUTTON TO ACTIVATE IT. DR. [NAME], A GYNECOLOGIST, ALREADY HAS EXPERIENCE WITH THE CLAMP AND NOTICED THAT THE ENERGY WAS ACTIVATING BY ITSELF WITHOUT PRESSING THE BUTTON. WHEN HE TRIED TO PRESS THE BUTTON, HE COULDN'T. ADVANCED FIXATION TROCAR, TWO OF 12 MM AND TWO OF 5 MM. THEY GAVE THE DOCTOR ANOTHER CLAMP. PATIENT STATUS: THERE WAS NO IMPACT ON THE PATIENT. INTERVENTION: THEY GAVE THE DOCTOR ANOTHER CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428823 ↗
• MalfunctionFeb 10, 2025Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: TOTAL LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: THE ACTIVATION BUTTON DID NOT RESPOND CORRECT. ACTIVATIONS WHEN NOT PRESSED AND SOMETIMES NO ACTIVATIONS WHEN PRESSED. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT. INTERVENTION: DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345788 ↗
• MalfunctionDec 12, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: VNOTE TECHNIQUE. EVENT DESCRIPTION: WHEN THE DR LATCHED THE HANDLE, IT GOT STUCK AND WOULDN¿T OPEN AGAIN, DR [NAME] HAD TO USE BOTH HANDS TO OPEN THE HANDLE BACK, SO IT GOT BROKEN. DR [NAME] COULD STILL CONTINUE THE SURGERY WITH THE HANDPIECE, BUT HE SAID IT WAS BROKEN AND NOT LATCHING PROPERLY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25JAN2024: WE HAVE REACHED OUT TO THE FIELD TEAM FOR FURTHER CLARIFICATION, AND THEY HAVE INFORMED US THAT THE DOCTOR CAN NOT RECALL ANY MISSING PART TIN THE HANDPIECE AND HE CLARIFIED THAT THE HANDLE BROKE AND STOPPED LATCHING ACCORDINGLY. WE HAVE ALSO CHECKED IF THE MISSING PIECE FELL INTO THE PATIENT, WE WERE UPDATED THAT THE HANDPIECE WAS USED IN A SURGERY WHICH WAS CONDUCTED VAGINALLY WHILE USING GELPOINT V-PATH (VNOTE TECHNIQUE) PATIENT STATUS: NO PATIENT IMPACT. INTERVENTION: DOCTOR CONTINUE THE SURGERY WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916130 ↗
• MalfunctionDec 12, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: EXPLORATORY LAPAROSCOPY RIGHT SALPINGECTOMY. EVENT DESCRIPTION: THE DEVICE WAS CLOSED IN ORDER TO FIRE AND SEAL THE OVARIAN LIGAMENT. THE DEVICE JAMMED. THE DEVICE WAS CLOSED ON THE TISSUE, FIRED AND PERFORATED THE SEALING, CUT THE TISSUE BUT DID NOT OPEN AFTER. I BROKE THE DEVICE HANDLE WITH A PEAN FORCEPS AND DESTROYED THE HANDLE. PATIENT STATUS: NOTHING. THE PATIENT IS FINE. INTERVENTION: I BROKE THE DEVICE HANDLE WITH A PEAN FORCEPS AND DESTROYED THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916018 ↗
• MalfunctionNov 7, 2024Self-Activation or Keying; No Apparent Adverse Event; Self-Activation or Keying; No Apparent Adverse Event

  PROCEDURE PERFORMED: LAR (LOW ANTERIOR RESECTION). EVENT DESCRIPTION: THE SURGERY WAS SUCCESSFULLY COMPLETED. AT THE END, ANOTHER DOCTOR WANTED TO LEARN ABOUT THE INSTRUMENT, AND THE OPERATING SURGEON DEMONSTRATED IT. WHEN THE SURGEON ACTIVATED THE INSTRUMENT WITHOUT CLAMPING ANY TISSUE, THE MAIN UNIT'S ALERT SOUNDED AS NORMAL. THIS HAPPENED CONSISTENTLY FOR ABOUT 7 ACTIVATIONS, WITH THE SAME NORMAL ALERT SOUND. THE USER IS UNSURE WHETHER THIS IS NORMAL. THE MAIN UNIT CONTINUED TO RESPOND AS IF OPERATING NORMALLY, EVEN WITHOUT TISSUE BEING CAUTERIZED. THE USER FELT THAT THE SIGNAL FEEDBACK WAS TOO FREQUENT WHEN USING THE INSTRUMENT AND FOUND IT DIFFICULT TO ADAPT TO THIS SITUATION. THERE IS NO IMPACT TO PATIENT. THERE ARE NO OTHER INSTRUMENTS TO AFFECT THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR VIA EMAIL ON 11OCT2024: THERE WERE NO ISSUES USING THIS DEVICE DURING THE LAR (LOW ANTERIOR RESECTION) SURGERY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE ISSUE AROSE POST-SURGERY WHEN ANOTHER PHYSICIAN WANTED TO UNDERSTAND THE USAGE OF THE DEVICE. DURING THE DEMONSTRATION BY THE OPERATING SURGEON, IT WAS FOUND THAT WHEN THE DEVICE WAS ACTIVATED TO BURN WITHOUT TISSU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20633007 ↗
• MalfunctionOct 24, 2024Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [ORIGINAL FRENCH EVENT DESCRIPTION]. AI TRANSLATION: ON (B)(6)2024, IN THE GYNECOLOGY UNIT, THE DEVICE STARTS COAGULATION BY TRIGGERING THE CLAMP WITHOUT PRESSING THE START BUTTON. CONVERSELY, THE BUTTON STOPS COAGULATION. THIS IS AN ISOLATED INCIDENT. INCIDENT WITH NO CONSEQUENCES FOR THE PATIENT. INTERVENTION: UNKNOWN. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525702 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TYPE OF PROCEDURE: SLEEVE SURGERY. EVENT DESCRIPTION: BLEEDING FROM SHORT GASTRIC ARTERY DURING SLEEVE GASTRECTOMY. THE BLEEDING WAS STARTED RIGHT AFTER FINISHING THE SEAL CYCLE AND OPENING THE JAWS OR 10-20S AFTER THAT. THEY USED CLIPS TO STOP BLEEDING BUT AFTER TRANSFERRING THE PATIENT TO ICU, A REDO SURGERY WAS PERFORMED BECAUSE OF THE BLEEDING VOLUME. ADDITIONAL FEEDBACK RECEIVED FROM DISTRIBUTOR THROUGH EMAIL ON JUNE 24, 2024: - NO BLEEDING OR TISSUE DAMAGE WAS OBSERVED - THE SURGEON DID NOT SEAL MULTIPLE TIMES AT THE SAME SITE WHEN TISSUE STUCK IS JAW - THE TISSUE WAS STICKING SOMETIMES THROUGHOUT THE PROCEDURE - THE BLEEDING OCCURRED FROM THE MAGER GASTRIC VESSELS AND ALSO OOZING SPECIFICALLY FROM GASTRIC REMNANT SIDE. - THERE IS NO TENSION APPLIED TO A VESSEL OR BUNDLE THAT WAS BEING SEALED - THE SURGEON ALWAYS CLEANS THE JAWS WITH WET SPONGE - THERE WAS NO ESCHAR BUILD UP - THE JAWS WERE CLEANED ANY TIME THEY BECOME CARBONIZED - THE SURGEON NOTICED IMPROVEMENT IN HEMOSTASIS WHEN THE JAWS WERE CLEANED - THE JAWS WERE NOT SUBMERGED IN FLUID AT ANY POINT DURING ACTIVATION - ALL PATIENTS UNDERWENT FULL CARDIOVASCULAR WORK UP BEFORE ANY BARIATRIC SURGERY - THE HANDPIECE WAS SOM

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19745887 ↗