VOYANT® 5mm Fusion Device EB210Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00607915138424), received between Jul 1, 2019 and Aug 11, 2026 — classified as 1 death, 6 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (18 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50215766 ↗
• MalfunctionMar 11, 2026Mechanical Jam

  PROCEDURE PERFORMED: SUPRACERVICAL HYSTERECTOMY + BILATERAL ADNEXECTOMY BY LAPAROSCOPY EVENT DESCRIPTION: THE VOYANT DEVICE, AFTER BEING CLAMPED, COULD NOT BE REOPENED. AFTER 5 MM OF NORMAL USE, THE SURGEON WAS UNABLE TO REOPEN THE VOYANT¿S JAWS. ADDITIONAL INFORMATION WAS RECEIVED BY NCA REF VIA EMAIL ON 18FEB2: USER REPORT WAS RECEIVED WITH ADDITIONAL INFORMATION: AI TRANSLATION: THE CLAMP JAMMED AFTER 5 MINUTES OF USE AND COULD NOT BE OPENED DESPITE SEVERAL ATTEMPTS. USE OF THIS DEVICE FOR A SUPRACERVICAL HYSTERECTOMY + BILATERAL ADNEXECTOMY BY LAPAROSCOPY. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT. INTERVENTION: THEY OPENED A NEW VOYANT DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576565 ↗
• MalfunctionFeb 13, 2026Self-Activation or Keying

  PROCEDURE PERFORMED: V NOTES HYSTERECTOMY EVENT DESCRIPTION: "[HOSPITAL NAME]" "THE DOCTOR WAS USING THE DEVICE TO GRASP AND SEAL VESSELS AND TISSUE BUNDLES. THE VOYANT HAND PIECE WAS ACTIVATING THE ENERGY WITHOUT THE DOCTOR PRESSING THE ACTIVATION BUTTON. IT HAPPENED 3 TIMES IN PATIENTS BODY AND 2 TIMES ON THE OT TABLE WITHOUT IT BEING HELD OR PRESSED BY ANYONE." INTERVENTION: THE GENERATOR SHOWED A MESSAGE : CHECK STUCK BUTTON SHE DEDUCTED THE BUTTON WAS STUCK AND TRIED TO PRESS IT AGAIN TO FIX THE PROBLEM. SHE CONTINUED THE SURGERY WITH THE SAME DEVICE. BUT AFTER THAT THE VOYANT WAS STILL FIRING ENERGY EVEN WHEN LEFT ON THE TABLE. PATIENT STATUS: --

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337514 ↗
• MalfunctionNov 20, 2025Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: AP RESECTION EVENT DESCRIPTION: USED LAPAROSCOPICALLY AROUND THE MESORECTUM ON AN AP RESECTION. SMALL VESSELS AS MAJOR VESSELS TRANSECTED USING A STAPLER SMALL VESSELS IN MESORECTUM BEING DIVIDED AND NOT SEALING AT ALL. NO ALARM TO ALERT AND HENCE BLEEDING ENSUED. THE DEVICE KEY HAD BEEN DISCARDED, SO WONT BE RETURNED FOR ANALYSIS. NO CLINICAL IMPACT TO PATIENT. (B)(6) 2025 ADDITIONAL INFORMATION RECEIVED FROM TERRITORY MANAGER VIA EMAIL. JUST IN CASE YOU HADN'T NOTICED, BUT THE FIRST THREE QUESTIONS WERE ANSWERED IN THE ORIGINAL REPORT. AP RESECTION. BUT UNAWARE HOW THE CASE PROCEEDED OR WHATEVER ELSE THEY USED AS I WASN'T PRESENT. AND SO, THE LAST QUESTION, I CAN'T ANSWER AND I'M UNSURE WHETHER THE SURGEON WOULD HAVE NOTICED THE ACTIVATION TONE OR NOT. (B)(6) 2025 ADDITIONAL INFORMATION RECEIVED FROM TERRITORY MANAGER VIA EMAIL IN RESPONSE TO REQUESTED INFORMATION "WHEN THE FUSE BUTTON WAS PRESSED, DID YOU NOTICE THE START TONE OR AN ¿ACTIVATING¿ MESSAGE ON THE GENERATOR, OR DID THE GENERATOR CONTINUE TO SHOW ¿READY¿ WITHOUT ANY APPARENT ACTIVITY? RESPONSE: THERE WAS AN ACTIVATION TONE BUT NO ALARM INTERVENTION: UNSURE ABOUT WHAT ELSE WAS USED. PATIENT STATUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610480 ↗
• MalfunctionNov 17, 2025Self-Activation or Keying; Self-Activation or Keying

  EVENT DESCRIPTION: DEVICE WAS BEING USED AS INTENDED. THIS IS A LONG TIME VOYANT USER (SINCE GEN 1). AFTER PRESSING THE ACTIVATION BUTTON, THE SURGEON IMMEDIATELY RELEASED THE BUTTON BUT STILL THE ENTIRE SEALING CYCLE WENT THROUGH. THIS HAPPENED MULTIPLE TIMES, EVEN SO OFTEN HE WAS ABLE TO MAKE A VIDEO WITH SEVERAL FAILURES. THE SURGEON REPLACED THE DEVICE. TYPE OF INTERVENTION: THE SURGEON REPLACED THE DEVICE. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576883 ↗
• MalfunctionSep 3, 2025Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: TLH. EVENT DESCRIPTION: [NAME REDACTED] DID A TLH WITH THE EB210. THE JAW WOULD NOT OPEN UPON UNLATCHING THE HANDLE DURING THE PROCEDURE. VISUAL INSPECTION SHOWS THE DEVICE KEY CUT AND DISCARDS AND UNLATCHED HANDLE WITH THE JAW OF THE DEVICE CLOSED. SOME ESCHAR BUILD UP SEEN AT THE OUTSIDE OF THE JAW. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 01SEP2025: THE INSTRUMENT¿S JAW DID NOT OPEN ANYMORE MIDWAY OF THE PROCEDURE. THE INSTRUMENT WAS CLEANED MULTIPLE TIME BEFORE IT OCCURRED. [NAME] HAD NO WARNING SIGNS, NOISE OR ALIKE PRECEDING THE EVENT. ALL WORKED FINE UNTIL THE JAW BLOCKED. THE INSTRUMENT¿S JAW WAS NOT STUCK ON TISSUE. [NAME] HAS TRIED TO OPEN BY FORCING CLOSING AND UNLATCHING THE HANDGRIP MULTIPLE TIMES WITHOUT EFFECT. HE COMPLETED THE PROCEDURE WITH ANOTHER EB210 AND WITHOUT ISSUES. NO PARTICULAR ADDITIONAL CIRCUMSTANCES. PATIENT STATUS: OK. INTERVENTION: COMPLETED THE PROCEDURE WITH ANOTHER EB210.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955942 ↗
• MalfunctionAug 19, 2025Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: LAP ANTERIOR RESCECTION. EVENT DESCRIPTION: DURING THE START OF THE CASE, BOWEL WAS BEING MOBILIZED FOR RESECTION. SURGEON HAD ALREADY COMPLETED A FEW ACTIVATIONS, REMOVED HANDPIECE FROM PATIENT. AS HE WAS PLACING TO BACK IN THE PATIENT THE HANDPIECE STARTED ACTIVATING WITHOUT THE DEPRESSION OF THE BUTTON. REMOVED FORM PATIENT IMMEDIATELY. THOUGHT MAYBE THE BUTTON WAS STUCK SO PRESSED IT A COUPLE TIMES TO RELEASE BUTTON. HANDPIECE WORKED AS USUALLY FOR ANOTHER 3 OR SO ACTIVATIONS BUT AS THEY WERE ABOUT THE TAKE THE IMA THE HANDPIECE STARTED ACTIVATION AGAIN WITHOUT BUTTON DEPRESSION. REMOVED IMMEDIATELY. GENERATOR WAS BEEPING, ALREY COED WAS NOT RECORED. NOT USED AGAIN. CLINICAL IMPACT TO THE PATIENT: YES, SOME PATIENT TISSUE WAS BURNT ON THE CONNECTIVE TISSUE. NIL CRITICAL HARM. 15.08.2025 ADDITIONAL INFORMATION RECEIVED FROM [TERRITORY MANAGER] VIA EMAIL: SO SORRY THAT WAS SUPPOSED TO SAY, ¿ALERT CODE¿ WAS NOT RECORDED. PATIENT STATUS: STABLE. INTERVENTION: USED [COMPETITOR DEVICE].

  Patient problems: Burn(s)

  MAUDE report 22842723 ↗
• MalfunctionJul 22, 2025Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: LAPAROSCOPIC LEFT HEMICOLECTOMY. EVENT DESCRIPTION: [HOSPITAL NAME]. [DISTRIBUTOR NAME]. DURING THE PROCEDURE, THE EB210 HANDPIECE FUNCTIONED NORMALLY UNTIL MIDWAY THE PROCEDURE, WHEN IT BEGAN RELEASING ENERGY WITHOUT THE ENERGY BUTTON BEING PRESSED. ADDITIONALLY, THE SURGEON EXPERIENCED DELAYS WHEN ACTIVATING THE ENERGY FUSE BUTTON, AND IN SOME INSTANCES, NO ENERGY WAS RELEASED. THE GENERATOR DISPLAYED AN ¿EARLY BUTTON RELEASE¿ ERROR. CONSEQUENTLY, THE DEVICE WAS REMOVED FROM THE PROCEDURE, AND THE SURGERY CONTINUED USING A [COMPETITOR DEVICE] BLUNT TIP DEVICE. FORTUNATELY, THERE WERE NO PATIENT COMPLICATIONS RESULTING FROM THIS ISSUE. ADDITIONAL INFORMATION PROVIDED ON 18JUL2025: THE HOSPITAL PURCHASED THE DEVICE THROUGH [HOSPITAL NAME]. CANNOT TELL YOU A NUMBER FOR HOW OFTEN THE INCIDENT WAS OBSERVED, CAN SAY IT WASN'T A PROBLEM UNTIL MIDWAY THE PROCEDURE. YES, THE READY MESSAGE WAS DISPLAYED ON THE SCREEN OF THE GENERATOR WHEN THE DEVICE WAS CONNECTED. YES UNTIL MIDWAY THE PROCEDURE, THE ACTIVATION TONE HAD A DELAY WHEN THE FUSE ACTIVATION BUTTON WAS PRESSED, AND ENERGY WAS RELEASED WITHOUT THE BUTTON BEING PRESSED. THE GENERATOR SHOWED THE EARLY BUTTON REL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569992 ↗
• MalfunctionMay 29, 2025Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: OTB (BILATERAL TUBAL OCCLUSION). 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. [DOCTOR] 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 ENERGY BUTTON, THE CONSOLE IMMEDIATELY MADE A SOUND WITHOUT DELIVERING THE ENERGY. THERE WAS NO IMPACT ON THE PATIENT. THE PATIENT IS STABLE AND THERE WERE NO CONSEQUENCES. PATIENT STATUS: THE PATIENT IS STABLE AND THERE WERE NO CONSEQUENCES. INTERVENTION: THEY GAVE THE DOCTOR ANOTHER "CLAMP".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110344 ↗
• MalfunctionMay 22, 2025Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: [WAS SEALING TISSUE. AFTER CUTTING COULD NOT OPEN DE JAWS. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP ON 9MAY25: IT IS NOT KNOWN WHAT CAUSED THE JAWS TO LOCK CLOSED. NO AUDIBLE OR VISIBLE DAMAGE PRIOR TO THE INCIDENT. THE JAWS WERE UNRESPONSIVE WHEN THE SURGEON ACTUATED THE HANDLE LEVEL. THE BLADE LEVER WAS ABLE TO SPRING BACK INTO POSITION/RETURN TO POSITION AUTOMATICALLY. NO TISSUE DAMAGE OR BLEEDING. IT WAS OBSERVED ONCE. THE DEVICE WAS USED FOR 30 ACTIVATIONS MORE LESS. TYPE OF INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: PERFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072178 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: AI TRANSLATION: THE SURGEON SAW NOTHING DURING THE OPERATION, ONLY AFTERWARDS. HERE'S THE E-MAIL THE SURGEON SENT ME AFTER MY REMINDERS TO COMPLETE PART 2 OF THE PMCF: ¿UNFORTUNATELY, THE PATIENT HAS HAD POST-OPERATIVE COMPLICATIONS. THERE WAS A LESION OF THE LEFT URETER DURING THE OPERATION. SHE WILL BENEFIT FROM A RE-IMPLANTATION TODAY. I DIDN'T NOTICE ANY PARTICULAR ANOMALY DURING THE OPERATION. IT'S PROBABLY A URETER THAT HAD TO BE CAUGHT IN THE ADHESIONS OF A PREVIOUS CAESAREAN SECTION WITH AN ATYPICAL PATH AND THAT WAS INJURED WITH THE USE OF THE THERMOFUSION FORCEPS NEARBY. THIS IS THE FIRST TIME I'VE SEEN THIS TYPE OF LESION WITH EITHER THE VOYANT FORCEPS OR ANY OTHER TYPE OF THERMOFUSION FORCEPS. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 4DEC24: THE SURGEON BELIEVES THAT THE URETHRAL INJURY WAS CAUSED BY A FUSION OF THE EB210 NEAR THE URETER. HE ASSUME THAT THE URETER, TRAPPED IN ADHESIONS FROM A PREVIOUS CESAREAN SECTION WITH AN ATYPICAL COURSE, WAS INJURED BY THE USE OF THE THERMOFUSION CLAMP NEARBY. THE PATIENT UNDERWENT URETERAL REIMPLANTATION TO CORRECT URINARY REFLUX. BUT DID NOT APPEAR T

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 21593950 ↗
• MalfunctionFeb 19, 2025Self-Activation or Keying; Self-Activation or Keying

  TYPE OF PROCEDURE: TOTAL HYSTERECTOMY PLUS SALPINGECTOMY BY LAPAROSCOPY EVENT DESCRIPTION: NAME: VOYANT 5 MM FUSIÓN. REFERENCE: EB210. SERIAL: (B)(6). DESCRIPTION EVENT: THEY ARE PERFORMING THE ACTION OF CHECKING THAT THE SEALING BUTTON IS ATTACHED, BUT IT IS PERCEIVED AS NORMAL. THE DOCTOR PRESSES THE SEALING BUTTON AGAIN. HOWEVER, THE ALARM REMAINS ACTIVE, AND THE CLAW DOES NOT SEAL. THE PATIENT IS BLEEDING. AS A RESULT, IT WAS NECESSARY TO USE ANOTHER CLAW TO COMPLETE THE SURGICAL PROCEDURE. SAMPLE AVAILABLE: NO. ADDITIONAL INFORMATION PROVIDED ON 27FEB2025 VIA EMAIL: NO PATIENT INJURY OCCURRED. PATIENT STABLE, PROCEDURE FINISHED SUCCESSFULLY. EVENT DATE WAS 05FEB2025. PROCEDURE WAS TOTAL HYSTERECTOMY PLUS SALPINGECTOMY BY LAPAROSCOPY. MONOPOLAR AND CONVENTIONAL BIPOLAR DEVICES USED AS WELL. THE HAND DEVICE WAS DISCARDED. UTERO-OVARIAN LIGAMENT WAS BEING GRASPED WHEN THE INCIDENT WAS OBSERVED. THE PATIENT DID NOT EXHIBIT ANY VASCULAR PATHOLOGY, AND THE DEVICE WAS NOT ACTIVATED ON DISEASED OR INFLAMED TISSUE. THE ISSUE WAS OBSERVED SINCE THE PROCEDURE STARTED THE INSTRUMENT NEVER WORKED. A LIQUID OR LUBRICANT SOLUTION WAS NOT APPLIED TO THE JAWS OR TISSUE DURING THE CASE. FROM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412338 ↗
• MalfunctionFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Failure to Seal; Adverse Event Without Identified Device or Use Problem; Failure to Seal

  PROCEDURE PERFORMED: HYSTERECTOMY EVENT DATE IS UNKNOWN. EVENT DESCRIPTION: SURGEON WAS PERFORMING A LAPAROSCOPIC HYSTERECTOMY. THE SURGEON HAS REPORTED THAT THE PATIENT HAD SOME BLEEDING DURING POST-OPERATIVE TIME. THE SURGEON BELIEVES THAT WAS DUE TO THE USE OF EB210, THE SEALING WAS NOT EFFECTIVE. TYPE OF INTERVENTION: NO OTHER ADDITIONAL INTERVENTION WAS REQUIRED. PATIENT STATUS: PATIENT IS OK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21329271 ↗
• MalfunctionNov 11, 2024Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: [ADNEXECTOMY]. EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME]. THERE WERE SEVERAL ALARMS (CLEAN JAWS, CHECK DEVICE ETC) THEY CLEANED THE JAWS. THEN THE ACTIVATION BUTTON WAS STUCK. DEVICE ACTIVATED ITSELF. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 6OCT24: THE DEVICE ACTIVATED WITHOUT INTENTIONALLY TOUCHING THE ACTIVATION BUTTON. THE HANDPIECE WAS JUST ACTIVATED BUT NOT ON TISSUE. TYPE OF INTERVENTION: [DEVICE REPLACEMENT]. PATIENT STATUS: [OK].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658479 ↗
• MalfunctionJul 23, 2024Self-Activation or Keying; Failure to Seal; Self-Activation or Keying; Failure to Seal

  PROCEDURE PERFORMED: [GASTRIC SLEEVE]. EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME] ACCORDING TO THE DOCTOR, HE STARTED PRESSING THE FUSE ACTIVATION BUTTON TO CAUTERIZE SOME VESSELS BUT AFTER TWO OR THREE ACTIVATIONS IT WAS SENDING THE TONE BUT IT WASN´T CAUTERIZING AT ALL AND NO ERROR WAS SHOWING IN THE GENERATOR SCREEN, AS IT APPEARED AS THE CYCLE WAS COMPLETED. HE ACTIVATED FOR ANOTHER CYCLE AND THE CAUTERIZATION WAS NOT PERFORMED AGAIN, SO THE SURGEON OPTED TO ASK FOR ANOTHER DEVICE. THEY OFFERED HIM AN EB215 MARYLAND FUSION DEVICE AND HE DIDN´T EXPERIENCED ANY ISSUES AT ALL. THE PATIENT HEALTH WAS NOT COMPROMISED IN ANY MOMENT DURING THE PROCEDURE. HERE IS TO MENTION THAT THE DEVICE WAS BRAND NEW, AS PER WHAT THEY SAID TO US. WE WERE NOT PRESENT AT THE MOMENT THE PROCEDURE TOOK PLACE, SO WE TALKED WITH THE STAFF OF THE INTEGRATED SERVICE WHO OFFERS THE DEVICES TO THE HOSPITAL (CONTROL SCIENTIFIC) SO THEY COULD SHARE WITH US THEIR TESTIMONIES. THE DEVICE USED WAS HANDLED TO US IN THE MAIN WHITE BOX WHICH WAS OPENED FOR THE PROCEDURE. THE FAILURE TOOK PLACE ON SATURDAY (B)(6) BUT THEY INFORMED TO US ON TUESDAY (B)(6). TYPE OF INTERVENTION: [EB210 WAS REPLACED WITH EB215]. PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812899 ↗
• MalfunctionJul 23, 2024Energy Output Problem; Self-Activation or Keying; Energy Output Problem; Self-Activation or Keying

  PROCEDURE PERFORMED: [GASTRIC SLEEVE]. EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME]. [NAME] AT [HOSPITAL NAME] WAS PERFORMING A GASTRIC SLEEVE PROCEDURE WHERE HE WAS USING EB210 BATCH# 1493746 EXPIRATION DATE 2026-06-19. VOYANT GENERATOR EA020 S/N (B)(6). ACCORDING TO THE DOCTOR, HE STARTED PRESSING THE FUSE ACTIVATION BUTTON TO CAUTERIZE SOME VESSELS BUT AFTER A COUPLE OF ACTIVACTIONS IT WAS SENDING THE TONE BUT IT WASN´T CAUTERIZING AT ALL AND NO ERROR WAS SHOWING IN THE GENERATOR SCREEN, AS IT APPEARED AS THE CYCLE WAS COMPLETED. HE ACTIVATED FOR ANOTHER CYCLE AND THE CAUTERIZATION WAS NOT PERFORMED AGAIN, SO THE SURGEON OPTED TO ASK FOR ANOTHER DEVICE. THEY OFFERED HIM AN EB215 MARYLAND FUSION DEVICE AND HE DIDN´T EXPERIENCED ANY ISSUES AT ALL. THE PATIENT HEALTH WAS NOT COMPROMISED IN ANY MOMENT DURING THE PROCEDURE. HERE IS TO MENTION THAT THE DEVICE WAS BRAND NEW, AS PER WHAT THEY SAID TO US. WE WERE NOT PRESENT AT THE MOMENT THE PROCEDURE TOOK PLACE, SO WE TALKED WITH THE STAFF OF THE INTEGRATED SERVICE WHO OFFERS THE DEVICES TO THE HOSPITAL (CONTROL SCIENTIFIC) SO THEY COULD SHARE WITH US THEIR TESTIMONIES. THE DEVICE USED WILL BE HANDLED TO US IN THE MAIN WHITE BOX WHICH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19808777 ↗
• MalfunctionJul 11, 2024Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: LOW ANTERIOR RESECTION. EVENT DESCRIPTION: HOSPITAL: [NAME]. PRODUCT: EB210. THIS INSTRUMENT TESTED FINE BEFORE SURGERY, BUT DURING ITS USE, IT INTERMITTENTLY EXHIBITS FUNCTIONALITY ISSUES, WORKING PROPERLY AT TIMES AND MALFUNCTIONING AT OTHERS. FURTHERMORE, EA020 DID NOT DETECT ANY ABNORMALITIES WITH EB210. PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 03MAY2024: WHEN THE EB210 IS ACTIVATED, IT SOMETIMES WORKS LIKE AN ELECTROCAUTERY, BUT SOMETIMES IT DOES NOT. IN THE ATTACHED VIDEO, EA020 RECOGNIZES THAT EB210 HAS BEEN ACTIVATED, BUT THE SURGEONS COLLECTIVELY SHOUTED "NO" (INDICATING A LACK OF ACTIVATION), CONFIRMING THE UNSTABLE ACTIVATION OF THE FUNCTION. ACCORDING TO USER FEEDBACK, THE TISSUE IS NOT THICK, AND ALTHOUGH THE DEVICE CAN SEAL THE TISSUE, OCCASIONALLY THE SEAL DOES NOT WORK. TYPE OF INTERVENTION: USER REPLACES WITH A NEW EB210 TO COMPLETE THE SURGERY. PATIENT STATUS: THERE IS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725755 ↗
• MalfunctionMay 24, 2024Energy Output Problem; Self-Activation or Keying; Energy Output Problem; Self-Activation or Keying

  PROCEDURE PERFORMED: TOTAL LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME]. PRODUCT: EB210. "DOCTOR INSERTED THE EB210 THROUGH 5MM APPLIED MEDICAL TROCAR. UPON SEALING THE FIRST SEAL ON THE MESOSALPINX TISSUE AND TRANSECTING THE TISSUE SUCCESSFULLY RIGHT AFTER, SUBSEQUENT 2ND, 3RD, AND 4TH SEALS HAD NO REACTIONS WITHIN THE TISSUE. IT DID NOT APPEAR LIKE THE ENERGY HAS BEEN DELIVERED TO THE TISSUE ALTHOUGH THE GENERATOR FUNCTIONED NORMALLY WITH THE START AND END TONE RINGING. THE DOCTOR TRIED THE SEAL AGAIN, AND IT SEEMED LIKE THERE WAS LITTLE TO NO ENERGY DELIVERED TO THE TISSUE. DOCTOR PROCEEDED TO TRANSECT THE TISSUE REGARDLESS AND THE BLEEDING OCCURRED. PHYSICIAN THEN ASKED FOR [COMPETITOR PRODUCT] AND SUCCESSFULLY FINISHED THE SURGERY. DOCTOR NOTED THAT THROUGHOUT THE REMAINDER OF THE PROCEDURE, THE DOCTOR WAS ABLE TO FINISH THE SURGERY WITH SUCCESSFUL SEALS WITH LIGASURE UNLIKE APPLIED MEDICAL'S VOYANT; HOWEVER, IT DID SEEM LIKE [COMPETITOR PRODUCT] WAS ALSO NOT WORKING AS WELL AS USUAL." PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM VIA EMAIL ON 30MAY2024 NO THE GENERATOR WAS NOT MAKING ANY ALARM TONES DURING THE PROCEDURE. GENERAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393802 ↗
• MalfunctionApr 30, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: THE EVENT DATE IS UNKNOWN. LONG TIME VOYANT USERS, USAGE AS INTENDED. JAWS DID NOT OPEN (INSIDE NOR OUTSIDE THE PATIENT). ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 3APR24: THEY WERE UNABLE TO OPEN THE JAWS. THE JAWS WERE LOCKED ON TISSUE AND THEY USED A DIFFERENT VOYANT TO DISSECT THE LOCKED ONE. NORMAL LAPAROSCOPIC INSTRUMENTS AND GENERATOR USED DURING PROCEDURE. TYPE OF INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217558 ↗
• MalfunctionMar 25, 2024Device Remains Activated; Device Remains Activated

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: LONG TIME VOYANT USERS, USED DEVICE AS INTENDED. THE DEVICE DID NOT STOP ACTIVATING. EVEN WHEN NOT HOLDING THE ACTIVATION BUTTON. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 03APR24: THE DEVICE CONTINUE TO RELEASE RF ENERGY AFTER THE BUTTON WAS RELEASED. THE UNINTENDED OUTPUT INDEED OCCURRED AFTER RELEASING THE BUTTON. THE USER STOPPED USING THE DEVICE AFTER ONE TIME. APPROX. 15 TIMES. IT IS UNKNOWN IF THERE WERE ALARMS. THE JAWS WERE BEING CLEANED AS INTENDED (LONG TIME VOYANT USERS). THE NUMBER OF TIMES IS NOT KNOWN. INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18974106 ↗
• MalfunctionFeb 26, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: BILATERAL TUBAL LIGATION EVENT DESCRIPTION: AS THE TISSUES ARE GRABBED AND CUT AND SEPARATED AFTER THE TIP OF THE PROBE GRASPED THE TISSUE, IT WAS NOT SEPARATED FROM THE TISSUE. IN ORDER TO SAVE THE TISSUE, THE TIP OF THE PROBE WAS SEPARATED BY DISSECTING WITH ANOTHER ENERGY TOOL. ADDITIONAL INFO RECEIVED ON (B)(6) 24: SHE SAYS THE TISSUE QUITE THIN. THE LOCKING MECHANISM REMAINED STUCK AND DID NOT SEPARATED FROM TISSUE. WE OPENED [COMPETITOR DEVICE] TO SEPARATE TISSUE. THESE INFORMATIONS WHAT ALL WE GOT FROM THE DOCTOR. ADDITIONAL INFO RECEIVED ON (B)(6) 2024: YES, WE CAN CONFIRM CORRECT DEVICE RETURNED. CUSTOMER EXPERIENCED NO CUTTING. WE CAN'T CONFIRM. HOWEVER, WE HEARD DEVICE WAS RE-STERILIZED. THEY HAD A HARD TIME SEPARATING IT FROM THE TISSUE. BUT THEY BARELY MANAGED TO SEPARATE THEM. YES, THEY CUT AROUND THE JAWS WITH ANOTHER DEVICE. TYPE OF INTERVENTION: THE TIP OF THE PROBE WAS SEPARATED BY DISSECTING WITH ANOTHER ENERGY TOOL. PATIENT STATUS: THE PATIENT IS IN A GOOD CONDITION AS NO INJURIES WERE SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784809 ↗
• MalfunctionNov 15, 2023Contamination; Contamination

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: #(B)(4), (2027111-2023-00711). COMPLAINT 2 OF 2: #(B)(4), (CURRENT MEDWATCH). EB210 WAS INSERTED THROUGH TROCAR AND WAS FOUND TO HAVE A HAIR-LIKE PARTICLE ON THE DEVICE. A SECOND EB210 WAS OPENED AND WAS REPORTED TO HAVE A LAYER OF DUST ON THE DEVICE. THE CASE WAS COMPLETED USING THE SECOND EB210. NO PATIENT INJURY OCCURRED. SECOND EB210 IS NOT RETURNING. ADDITIONAL INFORMATION RECEIVED ON 30OCT2023 VIA EMAIL FROM ACCOUNT MANAGER: NO IMAGES OF HAIR TAKEN ON THE FIRST EB210. NO IMAGES OF THE DUST TAKEN ON THE SECOND DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SECOND EB210. TYPE OF INTERVENTION: CASE WAS COMPLETED USING THE SECOND EB210. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144601 ↗
• MalfunctionNov 8, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: LAPAROSCOPIC APPENDECTOMY DETAILED DESCRIPTION OF EVENT: [HOSPITAL]. EB210 WAS INSERTED THROUGH TROCAR AND WAS FOUND TO HAVE A HAIR-LIKE PARTICLE ON THE DEVICE. A SECOND EB210 WAS OPENED AND WAS REPORTED TO HAVE A LAYER OF DUST ON THE DEVICE. THE CASE WAS COMPLETED USING THE SECOND EB210. NO PATIENT INJURY OCCURRED. FIRST EB210 IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 30OCT2023 VIA EMAIL FROM [NAME], ACCOUNT MANAGER: NO IMAGES OF HAIR TAKEN ON THE FIRST EB210. NO IMAGES OF THE DUST TAKEN ON THE SECOND DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SECOND EB210. PATIENT STATUS: NO PATIENT INJURY OCCURRED. TYPE OF INTERVENTION: THE CASE WAS COMPLETED USING THE SECOND EB210.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097324 ↗
• MalfunctionAug 9, 2023Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: LAPAROSCOPIC TOTAL HYSTERECTOMY EVENT DESCRIPTION: SURGEON USING VOYANT 5MM FUSION ON OVARIAN LIGAMENT. PRIOR REGISTRAR HAD BEEN USING THE DEVICE AND CAUSING A LOT OF SEAL CYCLE ERRORS DUE TO ACCIDENTALLY ACTIVATING THE JAWS, UNFAMILIARITY WITH THE LOCKING HANDLE. HOWEVER, THE SEAL CYCLE WAS STILL ABLE TO BE COMPLETED. SURGEON TOOK THE DEVICE AND ACTIVATED HIMSELF, THE SURGEON SOMETIMES CUTS SHORT THE SEAL CYCLE AND CAUSES THE SEAL CYCLE ERROR. DURING SEALING, THE SEAL CYCLE WOULD NOT COMPLETE AND THE GENERATOR PRODUCED A SEAL CYCLE ISSUE - THE DEVICE WAS ACTIVATED TWICE MORE AND SEAL CYCLE WOULD NOT COMPLETE, RESULTING IN SEAL CYCLE ERROR. WE REPOSITIONED THE DEVICE, AWAY FROM METAL AND THE CYCLE WOULD STILL NOT COMPLETE SUCCESSFULLY IT WAS AT THIS POINT THE SURGEON SWAPPED THE DEVICE FOR A NEW EB210 AND SEALED THE EXISTING AREA WITHOUT ISSUE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 26JUL23: THE SURGEON WAS TRYING TO SEAL OVARIAN TISSUE, UNSURE OF SPECIFIC TISSUE. THE DEVICE HAD BEEN IN USE PRIOR TO ME ATTENDING THE CASE. (NO RECORD OF NUMBER OF ACTIVATIONS). THE ISSUES OCCURRED AFTER THE REGISTRAR HAD USED THE DEVICE FOR ROUGHLY 10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494529 ↗
• MalfunctionJun 12, 2023Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: OVARIECTOMY/TUBECTOMY/ADNEXECTOMY EVENT DESCRIPTION: INFO RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 8MAY23: THE EB210 REFUSED WORKING FROM THE START OF THE PROCEDURE. NO SOUND, NO SEALING ACTIVITY. EVENT OCCURRED ON APRIL 12TH. NAME OF PROCEDURE BEING PERFORMED WAS OVARIECTOMY/TUBECTOMY/ADNEXECTOMY. THE EVENT HAPPENED DURING USE, AT THE BEGINNING OF THE PROCEDURE. THERE WAS NO PATIENT INJURY, PATIENT STATUS IS OKAY. THE USER RESTARTED THE GENERATOR, PLUGGED OUT THE EB210 AND RECONNECTED, ¿ TOOK A NEW DEVICE. UPDATE TO REPORTABILITY VIA DEVICE EVALUATION ON 19MAY2023: A MISALIGNED FUSE SWITCH WAS FOUND DURING EVALUATION, LEADING TO UNINTENDED RF ACTIVATION TYPE OF INTERVENTION: RESTARTED THE GENERATOR, PLUGGED OUT THE EB210 AND RECONNECTED. TOOK A NEW DEVICE. PATIENT STATUS: OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17109679 ↗