VOYANT® Fine Fusion Device EB230Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00607915138240), received between Aug 13, 2019 and Sep 11, 2025 — classified as 14 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (3 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NO SURGERY WAS PERFORMED. DETAILED DESCRIPTION OF EVENT: WHEN UNPACKING THE VOYANT CLAMP, THE NURSE DISCOVERED A HAIR IN THE STERILE PACKAGING. NOT USED DUE TO THE PRESENCE OF A HAIR IN THE STERILE PACKAGING. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 08SEP25: THE CUSTOMER HAS ALREADY SET ASIDE THE PLIERS FOR RETURN. TM WILL FOLLOW UP WITH THE CUSTOMER TO SEE IF PHOTOS CAN BE TAKEN. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 09SEP25: THE TM VISITED THE CUSTOMER, AND FOUR [4] IMAGES WERE TAKEN. PATIENT STATUS: NA (BEFORE USE). TYPE OF INTERVENTION: THE USER TOOK ANOTHER STERILE CLAMP FROM STOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23034299 ↗
• InjuryFeb 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE PERFORMED: THYROIDECTOMY. EVENT DESCRIPTION: THIS IS NOT A SINGLE EVENT, BUT A COMPLAINT RECEIVED BY EMAIL FROM THE CUSTOMER, TODAY. THIS IS A FREE TRANSLATION FROM THE EMAIL RECEIVE: ¿I DON'T FEEL COMFORTABLE USING THE VOYANT MACHINE DUE TO PREVIOUS CASES OF POST-OPERATIVE HEMATOMA. DESPITE BEING DESCRIBED AS POSSIBLE COMPLICATIONS, THE INCIDENCE INCREASED IN RELATION TO THE LITERATURE WHEN I USED THIS DEVICE. I EMPHASIZE THAT THESE ARE OUTPATIENTS WITH AN INCREASED RISK OF BLEEDING AT HOME AND AIRWAY COMPROMISE. IN ADDITION TO FORCING ME TO LIGATE EVERYTHING A SECOND TIME WITH VICRYL AND THEREFORE LONGER SURGERY TIME, MORE COSTS, IT ALSO FORCES ME TO DISCHARGE PATIENTS WITH A DRAIN TO ENSURE AIRWAY PATENCY. THIS IS UNCOMFORTABLE FOR THE PATIENT. THE VOYANT DEVICE SIMULTANEOUSLY STICKS TO THE TISSUES, CAUSING TEARING INSTEAD OF SEALING.¿ ADDITIONAL INFORMATION RECEIVED BY PHONE FROM THE TERRITORY MANAGER ON 11FEB2025: THIS WILL NOT BE POSSIBLE TO OBTAIN ANY ADDITIONAL INFORMATION ON THIS COMPLAINT AS THIS IS AN ANONYMOUS DECLARATION RECEIVED BY THE WAREHOUSE LOGISTIC DEPARTMENT MEANING THAT WE WILL NOT BE ABLE TO REACH OUT TO ANY SPECIFIC SURGEON REGARDING THIS MATTER. T

  Patient problems: Hematoma

  MAUDE report 21403636 ↗
• InjuryJan 6, 2025Patient Device Interaction Problem; Excessive Heating; Patient Device Interaction Problem; Excessive Heating

  PROCEDURE PERFORMED: LEFT PAROTIDECTOMY -TOTALLY 57 ACTIVATIONS. EVENT DESCRIPTION: DURING A LEFT PAROTIDECTOMY PROCEDURE PERFORMED ON (B)(6) 2024, FOR [AGE REDACTED] PATIENT, THE VOYANT FINE FUSION DEVICE WAS UTILIZED, AT THE CONCLUSION OF THE PROCEDURE, JUST BEFORE CLOSING THE SKIN, A SMALL 1 CM SKIN BURN WAS OBSERVED ON THE PATIENT, THE CAUSE OF THE BURN REMAINS UNCLEAR, ALL PROCEDURAL STEPS WERE CONSISTENT WITH THOSE FOLLOWED IN SIMILAR CASES, WITH THE ONLY NOTABLE DIFFERENCE BEING THE USE OF THE VOYANT DEVICE. ON THE DAY THE CONSULTANTS WERE NOT SURE WHAT CAUSED THE BURN. WHEN RE VISITING ON (B)(6) AND SPEAKING WITH THE CONSULTANTS AGAIN, THERE WAS A CONCERN THAT THE ONLY DIFFERING FACTOR WAS THE VOYANT SYSTEM, BUT THEY STILL HAVE NO CLUE WHAT CAUSED IT. FROM MY OBSERVATIONS IN THE PROCEDURES, THE JAWS DID NOT TOUCH THE SKIN. -ALL SURGEONS USED AGAIN ON (B)(6) PM FOR THEIR THYROIDECTOMY CASE AND HAD NO ISSUES. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON (B)(6) 2025: LOT NUMBER OF THE DEVICE 1531819, 1 (LEFT PAROTIDECTOMY) -TOTALLY 57 ACTIVATIONS. THE SKIN BURN WAS TRIMMED OVER THE EDGE USING A SCALPEL, AND TWO SUTURES WERE PLACED FOR CLOSURE. STANDARD ENT IN

  Patient problems: Burn(s)

  MAUDE report 21087451 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: THYROIDECTOMY. *EVENT DATE IS UNKNOWN* EVENT DESCRIPTION: COMPLAINT 1 OF 7: (B)(4). COMPLAINT 2 OF 7: (B)(4). COMPLAINT 3 OF 7: (B)(4). COMPLAINT 4 OF 7: (B)(4). COMPLAINT 5 OF 7: (B)(4). COMPLAINT 6 OF 7: (B)(4). COMPLAINT 7 OF 7: (B)(4). IN A CASE STUDY IN A HOSPITAL IN PORTUGAL, THE SURGEON HAPPENED TO MENTION THAT IN THE PAST YEAR THEY'VE HAD 7 POST OP BLEEDING CASES WHILE USING A VOYANT HANDPIECE (TO BE CONFIRMED WHICH ONE, MOST LIKELY FINE FUSION). ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 22AUG24: THE SURGEONS INFORMED THAT LAST YEAR HAD SOME POST OP BLEEDING AND THE PATIENTS WENT AGAIN TO THE OR. COULDN'T SPECIFY IF THE EVENT WAS VOYANT RELATED. SURGEON IS GOING TO SEE THE FILES AND INFORM ASAP IF IT WERE SURGERIES WHERE VOYANT WERE USED. NO NEED A CLOSING LETTER. ADDITIONAL INFORMATION FROM CALL WITH COMPANY REP. ON 27AUG24 (SEE ATTACHMENT "2024-002142 - 2024-002148 CALL DISCUSSION SUMMARY 27AUG24") 7 POST-OPERATIVE BLEEDING EVENTS HAPPENED SOMETIME LAST YEAR (2023); THE SPECIFIC EVENT DATES ARE UNKNOWN. THE COMPLICATIONS ARE PROBABLY LINKED TO THE USE OF VOYANT HANDPIECES: STILL YET TO BE CONFIRMED WITH THE SURGEON. THE PATIENTS ARE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20102788 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: THYROIDECTOMY. *EVENT DATE IS UNKNOWN* EVENT DESCRIPTION: COMPLAINT 1 OF 7: (B)(4). IN A CASE STUDY IN A HOSPITAL IN PORTUGAL, THE SURGEON HAPPENED TO MENTION THAT IN THE PAST YEAR THEY'VE HAD 7 POST OP BLEEDING CASES WHILE USING A VOYANT HANDPIECE (TO BE CONFIRMED WHICH ONE, MOST LIKELY FINE FUSION). ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 22AUG24: THE SURGEONS INFORMED THAT LAST YEAR HAD SOME POST OP BLEEDING AND THE PATIENTS WENT AGAIN TO THE OR. COULDN'T SPECIFY IF THE EVENT WAS VOYANT RELATED. SURGEON IS GOING TO SEE THE FILES AND INFORM ASAP IF IT WERE SURGERIES WHERE VOYANT WERE USED. NO NEED A CLOSING LETTER. ADDITIONAL INFORMATION FROM CALL WITH COMPANY REP. ON 27AUG24 (SEE ATTACHMENT "2024-002142 - 2024-002148 CALL DISCUSSION SUMMARY 27AUG24") 7 POST-OPERATIVE BLEEDING EVENTS HAPPENED SOMETIME LAST YEAR (2023); THE SPECIFIC EVENT DATES ARE UNKNOWN. THE COMPLICATIONS ARE PROBABLY LINKED TO THE USE OF VOYANT HANDPIECES: STILL YET TO BE CONFIRMED WITH THE SURGEON. THE PATIENTS ARE FINE, AND THE POST-OPERATIVE BLEEDING COMPLICATIONS WERE SUCCESSFULLY TREATED. GIVEN THAT THESE EVENTS HAPPENED RELATIVELY LONG AGO, THE FAULTY DEVICES ARE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20102098 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: THYROIDECTOMY *EVENT DATE IS UNKNOWN* EVENT DESCRIPTION: COMPLAINT 1 OF 7: (B)(4). IN A CASE STUDY IN A HOSPITAL IN PORTUGAL, THE SURGEON HAPPENED TO MENTION THAT IN THE PAST YEAR THEY'VE HAD 7 POST OP BLEEDING CASES WHILE USING A VOYANT HANDPIECE (TO BE CONFIRMED WHICH ONE, MOST LIKELY FINE FUSION). ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 22AUG24: THE SURGEONS INFORMED THAT LAST YEAR HAD SOME POST OP BLEEDING AND THE PATIENTS WENT AGAIN TO THE OR. COULDN'T SPECIFY IF THE EVENT WAS VOYANT RELATED. SURGEON IS GOING TO SEE THE FILES AND INFORM ASAP IF IT WERE SURGERIES WHERE VOYANT WERE USED. NO NEED A CLOSING LETTER. ADDITIONAL INFORMATION FROM CALL WITH COMPANY REP. ON 27AUG24 (B)(4) CALL DISCUSSION SUMMARY 27AUG24") 7 POST-OPERATIVE BLEEDING EVENTS HAPPENED SOMETIME LAST YEAR (2023); THE SPECIFIC EVENT DATES ARE UNKNOWN. THE COMPLICATIONS ARE PROBABLY LINKED TO THE USE OF VOYANT HANDPIECES: STILL YET TO BE CONFIRMED WITH THE SURGEON. THE PATIENTS ARE FINE, AND THE POST-OPERATIVE BLEEDING COMPLICATIONS WERE SUCCESSFULLY TREATED. GIVEN THAT THESE EVENTS HAPPENED RELATIVELY LONG AGO, THE FAULTY DEVICES ARE UNLIKELY TO BE RECOVERED AND WON¿T B

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20101995 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: THYROIDECTOMY. *EVENT DATE IS UNKNOWN* EVENT DESCRIPTION: COMPLAINT 1 OF 7: (B)(4). COMPLAINT 2 OF 7: (B)(4). COMPLAINT 3 OF 7: (B)(4). COMPLAINT 4 OF 7: (B)(4). COMPLAINT 5 OF 7: (B)(4). COMPLAINT 6 OF 7: (B)(4). COMPLAINT 7 OF 7: (B)(4). IN A CASE STUDY IN A HOSPITAL IN PORTUGAL, THE SURGEON HAPPENED TO MENTION THAT IN THE PAST YEAR THEY'VE HAD 7 POST OP BLEEDING CASES WHILE USING A VOYANT HANDPIECE (TO BE CONFIRMED WHICH ONE, MOST LIKELY FINE FUSION). ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 22AUG24: THE SURGEONS INFORMED THAT LAST YEAR HAD SOME POST OP BLEEDING AND THE PATIENTS WENT AGAIN TO THE OPERATING ROOM. COULDN'T SPECIFY IF THE EVENT WAS VOYANT RELATED. SURGEON IS GOING TO SEE THE FILES AND INFORM ASAP IF IT WERE SURGERIES WHERE VOYANT WERE USED. NO NEED A CLOSING LETTER. ADDITIONAL INFORMATION FROM CALL WITH COMPANY REP. ON 27AUG24 (B)(4) 7 POST-OPERATIVE BLEEDING EVENTS HAPPENED SOMETIME LAST YEAR ((B)(6) 2023); THE SPECIFIC EVENT DATES ARE UNKNOWN. THE COMPLICATIONS ARE PROBABLY LINKED TO THE USE OF VOYANT HANDPIECES: STILL YET TO BE CONFIRMED WITH THE SURGEON. THE PATIENTS ARE FINE, AND THE POST-OPERATIVE BLEEDING COMPLICATION

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20101390 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: THYROIDECTOMY. *EVENT DATE IS UNKNOWN*. EVENT DESCRIPTION: (B)(4). IN A CASE STUDY IN A HOSPITAL IN PORTUGAL, THE SURGEON HAPPENED TO MENTION THAT IN THE PAST YEAR THEY'VE HAD 7 POST OP BLEEDING CASES WHILE USING A VOYANT HANDPIECE (TO BE CONFIRMED WHICH ONE, MOST LIKELY FINE FUSION). ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 22AUG24: THE SURGEONS INFORMED THAT LAST YEAR HAD SOME POST OP BLEEDING AND THE PATIENTS WENT AGAIN TO THE OR. COULDN'T SPECIFY IF THE EVENT WAS VOYANT RELATED. SURGEON IS GOING TO SEE THE FILES AND INFORM ASAP IF IT WERE SURGERIES WHERE VOYANT WERE USED. NO NEED A CLOSING LETTER. ADDITIONAL INFORMATION FROM CALL WITH COMPANY REP. ON (B)(6) 2024 (SEE ATTACHMENT "2024-002142 - 2024-002148 CALL DISCUSSION SUMMARY (B)(6) 2024") 7 POST-OPERATIVE BLEEDING EVENTS HAPPENED SOMETIME LAST YEAR (2023); THE SPECIFIC EVENT DATES ARE UNKNOWN. THE COMPLICATIONS ARE PROBABLY LINKED TO THE USE OF VOYANT HANDPIECES: STILL YET TO BE CONFIRMED WITH THE SURGEON. THE PATIENTS ARE FINE, AND THE POST-OPERATIVE BLEEDING COMPLICATIONS WERE SUCCESSFULLY TREATED. GIVEN THAT THESE EVENTS HAPPENED RELATIVELY LONG AGO, THE FAULTY DEVICES ARE UNLIKELY

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20101111 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: THYROIDECTOMY *EVENT DATE IS UNKNOWN* EVENT DESCRIPTION: COMPLAINT 1 OF 7:(B)(4). IN A CASE STUDY IN A HOSPITAL IN PORTUGAL, THE SURGEON HAPPENED TO MENTION THAT IN THE PAST YEAR THEY'VE HAD 7 POST OP BLEEDING CASES WHILE USING A VOYANT HANDPIECE (TO BE CONFIRMED WHICH ONE, MOST LIKELY FINE FUSION). ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 22AUG24: THE SURGEONS INFORMED THAT LAST YEAR HAD SOME POST OP BLEEDING AND THE PATIENTS WENT AGAIN TO THE OR. COULDN'T SPECIFY IF THE EVENT WAS VOYANT RELATED. SURGEON IS GOING TO SEE THE FILES AND INFORM ASAP IF IT WERE SURGERIES WHERE VOYANT WERE USED. NO NEED A CLOSING LETTER. ADDITIONAL INFORMATION FROM CALL WITH COMPANY REP. ON 27AUG24 (SEE ATTACHMENT "2024-002142 - 2024-002148 CALL DISCUSSION SUMMARY 27AUG24") 7 POST-OPERATIVE BLEEDING EVENTS HAPPENED SOMETIME LAST YEAR (2023); THE SPECIFIC EVENT DATES ARE UNKNOWN. THE COMPLICATIONS ARE PROBABLY LINKED TO THE USE OF VOYANT HANDPIECES: STILL YET TO BE CONFIRMED WITH THE SURGEON. THE PATIENTS ARE FINE, AND THE POST-OPERATIVE BLEEDING COMPLICATIONS WERE SUCCESSFULLY TREATED. GIVEN THAT THESE EVENTS HAPPENED RELATIVELY LONG AGO, THE FAULTY DEVICES ARE U

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20100730 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: THYROIDECTOMY *EVENT DATE IS UNKNOWN* EVENT DESCRIPTION: COMPLAINT 1 OF 7: (B)(4). IN A CASE STUDY IN A HOSPITAL IN PORTUGAL, THE SURGEON HAPPENED TO MENTION THAT IN THE PAST YEAR THEY'VE HAD 7 POST OP BLEEDING CASES WHILE USING A VOYANT HANDPIECE (TO BE CONFIRMED WHICH ONE, MOST LIKELY FINE FUSION). ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 22AUG24: THE SURGEONS INFORMED THAT LAST YEAR HAD SOME POST OP BLEEDING AND THE PATIENTS WENT AGAIN TO THE OR. COULDN'T SPECIFY IF THE EVENT WAS VOYANT RELATED. SURGEON IS GOING TO SEE THE FILES AND INFORM ASAP IF IT WERE SURGERIES WHERE VOYANT WERE USED. NO NEED A CLOSING LETTER. ADDITIONAL INFORMATION FROM CALL WITH COMPANY REP. ON 27AUG24 (B)(4) CALL DISCUSSION SUMMARY 27AUG24"). 7 POST-OPERATIVE BLEEDING EVENTS HAPPENED SOMETIME LAST YEAR (2023); THE SPECIFIC EVENT DATES ARE UNKNOWN. THE COMPLICATIONS ARE PROBABLY LINKED TO THE USE OF VOYANT HANDPIECES: STILL YET TO BE CONFIRMED WITH THE SURGEON. THE PATIENTS ARE FINE, AND THE POST-OPERATIVE BLEEDING COMPLICATIONS WERE SUCCESSFULLY TREATED. GIVEN THAT THESE EVENTS HAPPENED RELATIVELY LONG AGO, THE FAULTY DEVICES ARE UNLIKELY TO BE RECOVERED AND WON¿T

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20100599 ↗
• MalfunctionAug 23, 2024Excessive Heating; Excessive Heating

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: "SHE USED EB230 LAST WEEK FOR BREAST OP CASE. OUR DISTRIBUTOR GAVE EB230 TO HER FOR SAMPLING AND SHE USED. AND TODAY I AND OUR DISTRIBUTOR'S REPRESENTATIVE WENT TO SEE HER AND SHE SAID THAT THE JAW HAS A PROBLEM. THE PROBLEM IS THE HEAT PROBLEM. THE HEAT GET OUT FROM JAW SITE AND REACH OUT TO PROXIMAL FROM THE JAW TIP. SO ORGANS OR VESSELS' BURNED RESIDUES REMAIN DIRTILY. AND SHE SAID THAT SHE USED [COMPETITOR DEVICE] AND THERE ARE SOME MARGINS IN THEIR JAW. SO THE HEAT NEVER REACH OUT TO THAT POINT. " PRODUCT IS NOT AVAILABLE FOR RETURN. THIS IS 'SAMPLE' CASE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 12AUG2024: "THERE WAS UNINTENDED TISSUE BURNS OR UNINTENDED DAMAGE. THE UNINTENDED RF ENERGY OUTPUT FROM THE DEVICE OCCUR. THE SURGEON DID NOT USE MULTIPLE SEALS ON THE SAME TISSUE." TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW DEVICE. PATIENT STATUS: UNINTENDED TISSUE BURNS OR UNINTENDED DAMAGE.

  Patient problems: Burn(s)

  MAUDE report 20052036 ↗
• InjuryJan 11, 2024Excessive Heating; Excessive Heating

  PROCEDURE PERFORMED: THYROIDECTOMY. EVENT DESCRIPTION: (B)(6)] "THIN BURNS ON THE PATIENT'S NECK AFTER SURGERY. WHEN EB230 IS ACTIVATED, HEAT IS GENERATED ON THE BACK OF THE ROUND PLATE OF JAWS. HIGH FEVER IS FELT WHEN TOUCHED BY HAND." PRODUCT IS AVAILABLE FOR RETURN. TWO UNITS WILL BE RETURNED. TWO OF EB230 WERE USED ON THE EVENT DATE - ONE WAS USED IN THE MORNING AND THE OTHER ONE WAS USED IN THE AFTERNOON, BUT IT IS UNCERTAIN WHICH UNIT IS THE EVENT DEVICE. THE DEVICE WITH A DEVICE LOG SHOWING THE ACTIVATIONS WERE DONE IN THE MORNING (KOREA TIME) WOULD BE THE EVENT UNIT. ADDITIONAL INFORMATION RECEIVED ON 19APR24: "I¿VE SPOKEN WITH THE TERRITORY MANAGER. ACCORDING TO HIM, THE BURN ON THE PATIENT¿S NECK WAS NOT THAT SERIOUS AND THE HEAT FROM THE DEVICE CAUSED BLISTER ON THE PATIENT¿S NECK. THEY JUST APPLIED A WOUND DRESSING AND THE PATIENT WAS DISCHARGED FROM HOSPITAL. IT DIDN¿T LEAVE A SCAR." INTERVENTION: THEY JUST APPLIED A WOUND DRESSING AND THE PATIENT WAS DISCHARGED FROM HOSPITAL. IT DIDN¿T LEAVE A SCAR. PATIENT STATUS: THE PATIENT GOT A BURN ON HIS NECK.

  Patient problems: Burn(s)

  MAUDE report 18499206 ↗
• MalfunctionNov 20, 2023Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4). COMPLAINT 2 OF 2: (B)(4). ISSUE WITH 2 X FINE FUSION DURING THE SAME SURGICAL PROCEDURE. DEVICES USED AS USUAL BY THE SAME SURGEON. THE THIRD FINE FUSION DEVICES REPLACING THE 2 DEFECT ONES WORKED NORMALLY. WHEN THE DOCTOR WANTED TO CAUTERIZE, NOTHING HAPPENED. NO HEAT, NO CAUTERIZATION AND APPARENTLY NO ERROR SIGNAL ON THE GENERATOR. DEVICES REPLACED BY A THIRD ONE DURING THE SAME INTERVENTION. AND SURGEON WAS ABLE TO PERFORM HIS SURGERY. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 9NOV23: DATE OF EVENT: 20.09.23. HEMORRHOIDS WERE BEING GRASPED WHEN THE INCIDENT OCCURRED. THE PROBLEM OCCURRED IN THE FIRST MINUTE. THEY HEARD THE ACTIVATION AND END TONE, BUT COAGULATION WAS NOT OCCURRING, SO WE HAD TO CHANGE THE INDICATOR. NO THERMAL EFFECTS VISIBLE AT THE SITE. TYPE OF INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18178899 ↗
• MalfunctionNov 20, 2023Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: HYSTERECTOMIE. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4). COMPLAINT 2 OF 2: (B)(4). ISSUE WITH 2 X FINE FUSION DURING THE SAME SURGICAL PROCEDURE. DEVICES USED AS USUAL BY THE SAME SURGEON. THE THIRD FINE FUSION DEVICES REPLACING THE 2 DEFECT ONES WORKED NORMALLY. WHEN THE DOCTOR WANTED TO CAUTERIZE, NOTHING HAPPENED. NO HEAT, NO CAUTERIZATION AND APPARENTLY NO ERROR SIGNAL ON THE GENERATOR. DEVICES REPLACED BY A THIRD ONE DURING THE SAME INTERVENTION. AND SURGEON WAS ABLE TO PERFORM HIS SURGERY. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 09NOV2023: DATE OF EVENT: 20.09.23 HEMORRHOIDS WERE BEING GRASPED WHEN THE INCIDENT OCCURRED. THE PROBLEM OCCURRED IN THE FIRST MINUTE. THEY HEARD THE ACTIVATION AND END TONE, BUT COAGULATION WAS NOT OCCURRING, SO WE HAD TO CHANGE THE INDICATOR. NO THERMAL EFFECTS VISIBLE AT THE SITE. TYPE OF INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18178797 ↗
• MalfunctionJul 31, 2023Break; Break

  PROCEDURE PERFORMED: ENT PROCEDURE. EVENT DESCRIPTION: TRANSLATION: SMALL PROBLEM TODAY WITH OUR VOYANT COAGULATING DEVICE WHOSE SCREW HOLDING THE TWO BRANCHES FELL OUT IN THE MIDDLE OF THE PROCEDURE, REQUIRING THE USE OF A NEW DEVICE. THIS IS THE FIRST TIME THIS HAS HAPPENED TO ME WITH THIS INSTRUMENT. ADDITIONAL INFORMATION RECEIVED ON 04AUG22: TRANSLATION: THE TWO PRONGS SEPARATED ABOVE THE PATIENT AND UPON INSPECTION OF THE DEVICE, NO SCREWS WERE MISSING. IN ADDITION, AN X-RAY OF THE PATIENT'S NECK WAS REQUESTED THE NEXT DAY, WHICH DID NOT FIND A METALLIC FOREIGN BODY. THE INSTRUMENT WAS USED FOR APPROXIMATELY 45 MINUTES BEFORE THE PROBLEM OCCURRED. THIS WAS A TOTAL THYROIDECTOMY. EVERYTHING WENT PERFECTLY ON THE LEFT LOBE AND THE INCIDENT OCCURRED DURING THE DISSECTION OF THE RIGHT LOBE. PERHAPS AFTER ABOUT 20 CYCLES OF COAGULATION. TYPE OF INTERVENTION: DEVICE REPLACEMENT. AN X-RAY OF THE PATIENT'S NECK WAS REQUESTED THE NEXT DAY, WHICH DID NOT FIND A METALLIC FOREIGN BODY. PATIENT STATUS: NO CONCERN WAS MENTIONED REGARDING THE PATIENT¿S STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424873 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: TOTAL THYROIDECTOMY. EVENT DESCRIPTION: INFORMATION IN INITIAL EMAIL: UNFORTUNATELY I HAD TO TAKE THAT THYROID BACK TO THEATRE AS THE PATIENT BLED ON MONDAY- RETROSPECTIVELY I THINK I PREFER TO SEE THE TIP OF THE KNIFE AND IN THYROID THE LAST 1-2MM IS THE MOST IMPORTANT FOR ME. COMPLAINT FORM INFORMATION: I FOLLOWED UP WITH THE SURGEON REGARDING THE DEVICE POST-PROCEDURE VIA EMAIL WHERE I WAS INFORMED THE PATIENT HAD TO RETURN TO SURGERY LATER THAT DAY DUE TO BLEEDING. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 12JUN23: DID WELL AND WENT HOME ACCORDING TO THE PLAN ON TIME NEXT DAY¿. THEREFORE, PATIENT STATUS IS DISCHARGED. LOT NUMBER 1466154. TYPE OF INTERVENTION: ADDITIONAL SURGERY. PATIENT STATUS: DID WELL AND WENT HOME ACCORDING TO THE PLAN ON TIME NEXT DAY. THEREFORE, PATIENT STATUS IS DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17139896 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: HEMORRHOIDECTOMY. THE DEVICE WAS USED PROPERLY, AND ALSO THE TERRITORY MANAGER WAS PRESENT DURING THE SURGERY. AT THE END OF THE SURGERY THE PATIENT WAS IN WELL CONDITIONS. AND NO COMPLICATIONS WAS REPORTED UNTIL THIS EVENT. THIS PATIENT UNDERWENT SURGERY ON (B)(6) FOR GRADE 3 HEMORRHOIDS. BEFORE SURGERY, HE HAD MUCOSAL- HOMORRHOIDAL THAT WAS FRIABLE TO THE TOUCH AND SIGNS OF RECENT BLEEDING THROUGHOUT THE MUCOSA. ON POSTOPERATIVE DAY 7, HE WAS ADMITTED TO THE HOSPITAL DUE TO ABUNDANT RECTAL BLEEDING AND WAS OBSERVED FOR TWO DAYS WITHOUT REQUIRING REOPERATION. ALL LAB TESTS ARE FINE. CURRENTLY THE PATIENT IS FINE, HE LEFT THE HOSPITAL TODAY (B)(6) 2022 AND HAS NOT PRESENTED ANY MORE BLEEDING. CURRENTLY THE PATIENT IS FINE, HE LEFT THE HOSPITAL TODAY (B)(6) 2022 AFTER 2 DAYS OF OBSERVATIONS AND HAS NOT PRESENTED ANY MORE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14688845 ↗
• MalfunctionMay 26, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PROCEDURE PERFORMED: BILATERAL SALPINGECTOMY AFTER C-SECTION. DESCRIPTION: THE ACCT MGR WAS PRESENT FOR THE CASE. ON ACTIVATION 11, THE SURGEON WAS MAKING THE LAST SEAL ON THE FIRST FALLOPIAN TUBE. THE SURGEON DOUBLE SEALED AND THE TISSUE STUCK TO THE JAWS AND THERE WAS A SMALL AMOUNT OF BLEEDING. THE SURGEON TRIED SEALING AND CUTTING BUT THE TISSUE WOULD NOT COME LOOSE. THE TISSUE WAS CLAMPED FROM THE UTERUS SIDE AND SCISSORS WERE USED TO CUT AND PULL THE TISSUE OFF THE JAWS. AFTER THE 13TH ACTIVATION, THE JAWS WERE CLEANED WITH A WET LAP, BUT THE BLADE CHANNEL WAS NOT RUN. THERE WAS NO IMPROVEMENT WHEN THE JAWS WERE CLEANED. THE SURGEON STARTED ON THE 2ND FALLOPIAN TUBE AND THERE WAS TISSUE STICKING TO THE JAWS FROM THE FIRST ACTIVATION. THE SURGEON WAS ABLE TO PEEL THE TISSUE FROM THE DEVICE. THE JAWS WERE NOT SUBMERGED IN FLUID AT ANY POINT DURING ACTIVATION PRIOR TO THE TISSUE STICKING BEING OBSERVED. THE DEVICE WAS NOT ACTIVATED ON DISEASED OR INFLAMED TISSUE. A NEW HANDPIECE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. THE CORD WAS CUT, BUT BOTH THE DEVICE KEY AND HANDPIECE ARE AVAILABLE TO BE RETURNED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891349 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: CERVICAL LYMPH NODE DISSECTION (LEFT AND RIGHT) EVENT DESCRIPTION: DR [NAME] REPORTED TO ME ON (B)(6) 2021 THAT HIS PATIENT, WHO HAD BEEN OPERATED ON FOR CERVICAL LYMPH NODE DISSECTION, HAD POSTOPERATIVE COMPLICATIONS RESULTING FROM NERVES THAT WERE NO LONGER FUNCTIONAL LEADING TO SEVERE DISORDERS THAT PERSISTED UNTIL THIS DAY. THE CONCOMITANCE OF THESE EVENTS WITH AN UNDESIRABLE COMPLICATION OF THE PATIENT POSTOPERATIVELY AND OF THE TRIAL WITH OUR VOYANT/REF (B)(4) DEVICE LED DR. [NAME] TO ASK US ABOUT THE THERMAL SPREAD DIFFUSION OF OUR DEVICE. FURTHERMORE, I WOULD LIKE TO POINT OUT THAT NOTHING TO REPORT HAS BEEN OBSERVED DURING THE PER-OPERATION. PATIENT STATUS: NERVE DAMAGE.

  Patient problems: Nerve Damage

  MAUDE report 11599385 ↗
• InjuryAug 13, 2019Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: RIGHT PARATHYROIDECTOMY. FROM INITIAL NOTIFICATION: HIS LAST CASE HAD TO RETURN TO THE OPERATING ROOM THAT EVENING FOR A BLEED. I SPOKE TO HIM THIS MORNING AND HE IS CONCERNED IT WAS DUE TO VOYANT, ALTHOUGH HE CANNOT SAY THAT AS FACT. HE HAS ADVISED THAT ALTHOUGH HE IS WELL AWARE THIS IS A POTENTIAL COMPLICATION OF THE PROCEDURE, HE HAS NOT HAD THIS PREVIOUSLY WITH THE [COMPETITOR DEVICE], AND HAS NOT HAD A PATIENT RETURN FOR BLEEDS FULL STOP IN OVER 7 YEARS. THIS WAS THE FIRST IN 7 YEARS. [NAME FITM] WAS IN THE CASE HERSELF SO I AM NOT AWARE OF THE PATIENT CO-MORBIDITIES OR MEDICATIONS THAT COULD HAVE CONTRIBUTED. FROM CER FORM: MR [NAME] PERFORMED A RIGHT PARATHYROIDECTOMY ON A [AGE] YEAR OLD [SEX] PATIENT. MR [NAME] EXPLAINED THE REASON FOR THE SURGERY WAS SHE HAD ABNORMAL PARATHYROID FUNCTION. NO PREVIOUS SURGERY AND ON NO MEDICATIONS THAT COULD AFFECT THE TISSUE WHEN USING AN ENERGY DEVICE. HE USED THE VOYANT FINE FUSION DEVICE THROUGHOUT THE PROCEDURE ALONG WITH DIATHERMY. HE USED IT FOR A TOTAL OF 42 ACTIVATIONS, THE 6TH ACTIVATION WAS AN EARLY BUTTON RELEASE AND NOT A FULL CYCLE. THE DEVICE WAS CLEANED AFTER THE 7TH ACTIVATION. MR [NAME2] INFORMED ME ON

  Patient problems: Blood Loss

  MAUDE report 8891081 ↗