VOYANT 5mm Fusion DeviceRecalls & reported problems across all models

We found 4 models of VOYANT 5mm Fusion Device by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 257 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2016 and Aug 11, 2026 — classified as 1 death, 13 injuries, 243 malfunctions.

The most frequently reported specific device problem is “Output Problem” (68 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VOYANT 5mm Fusion Device problems

VOYANT 5mm Fusion Device models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VOYANT® 5mm Fusion Device EB010

  Electrosurgical, Cutting & Coagulation & Accessories
  190 reports
• VOYANT® 5mm Fusion Device EB210

  Electrosurgical, Cutting & Coagulation & Accessories
  1 death58 reports
• VOYANT® 5mm Fusion Device EB011

  Electrosurgical, Cutting & Coagulation & Accessories
  7 reports
• VOYANT® 5mm Fusion Device EB211

  Electrosurgical, Cutting & Coagulation & Accessories
  2 reports

Recent VOYANT 5mm Fusion Device adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 8, 2025Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: BARIATRIC SURGERY. EVENT DESCRIPTION: AFTER THE LAST FUSION THE ACTIVATION BUTTON CONTINUED TO LAUNCH FUSION CYCLE AFTER USING THE DEVICE SEEING SEVERAL TIMES THE FUSION ACTIVATION BUTTON REMAINED BLOCKED. PATIENT STATUS: NO PROBLEM. INTERVENTION: DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22746415 ↗
• 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 ↗

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