VOYANT® Maryland Fusion Device EB217Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00607915139377), received between Oct 9, 2020 and Apr 13, 2026 — classified as 7 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (7 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Failure to Deliver Energy; Mechanical Jam

  PROCEDURE PERFORMED: EBENTRACION. EVENT DESCRIPTION: USE IT CORRECTLY. I WAS SEALING A GLASS AND THE CLAMP JAMMED. PATIENT STATUS: OK. INTERVENTION: WAS REPLACED BY ANOTHER EB217.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860999 ↗
• MalfunctionNov 14, 2025Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: WITH THE FIRST INSTRUMENT, THE COAGULATION CYCLE STOPPED, AND THE SURGEON HAD TO REPLACE IT. THE SAME PROBLEM OCCURRED WITH THE SECOND INSTRUMENT. THE SURGEON THEN USED A [COMPETITOR DEVICE] TO COMPLETE THE SURGERY. IN TOTAL, THREE INSTRUMENTS WERE USED (2 VOYANTS + 1 [COMPETITOR DEVICE]). THE SURGEON EXPRESSED CONCERNS ABOUT THE ADDITIONAL COST FOR BOTH THE PATIENT AND THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 23OCT25: LAPAROTOMY FOR CANCER: DOING VERY WELL, STILL HOSPITALIZED, EXPECTED TO BE DISCHARGED THIS WEEK. NO INTRAOPERATIVE (BLEEDING) OR POSTOPERATIVE COMPLICATIONS. NO, I MANAGED TO OPEN THE JAWS, BUT THE COAGULATION CYCLE STOPPED AND THE JAWS DID NOT OPEN PROPERLY. IN THE END, THE SCRUB NURSE COULD NOT OPEN THE JAWS. OMENTUM. NOT VERY THICK. THE PATIENT DID NOT HAVE ANY VASCULAR PATHOLOGY OR WAS THE DEVICE ACTIVATED ON DISEASED OR INFLAMED TISSUE (CALCIFIED, SCARRED, ATHEROSCLEROTIC, FIBROTIC, ETC.). NO TENSION APPLIED TO A VESSEL OR TISSUE BUNDLE DURING SEALING. VERY SHORT TIME, LESS THAN 5 MINUTES (5¿8 ACTIVATIONS?). NO, NOT MORE THAN USUAL ESCHAR BUIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23562478 ↗
• MalfunctionNov 14, 2025Mechanical Problem; Mechanical Problem

  PROCEDURE PERFORMED: LAPAROTOMY FOR CANCER. EVENT DESCRIPTION: WITH THE FIRST INSTRUMENT, THE COAGULATION CYCLE STOPPED, AND THE SURGEON HAD TO REPLACE IT. THE SAME PROBLEM OCCURRED WITH THE SECOND INSTRUMENT. THE SURGEON THEN USED A [COMPETITOR DEVICE] TO COMPLETE THE SURGERY. IN TOTAL, THREE INSTRUMENTS WERE USED (2 VOYANTS + 1 [COMPETITOR DEVICE]). THE SURGEON EXPRESSED CONCERNS ABOUT THE ADDITIONAL COST FOR BOTH THE PATIENT AND THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 23OCT25: LAPAROTOMY FOR CANCER: DOING VERY WELL, STILL HOSPITALIZED, EXPECTED TO BE DISCHARGED THIS WEEK. NO INTRAOPERATIVE (BLEEDING) OR POSTOPERATIVE COMPLICATIONS. NO, I MANAGED TO OPEN THE JAWS, BUT THE COAGULATION CYCLE STOPPED AND THE JAWS DID NOT OPEN PROPERLY. IN THE END, THE SCRUB NURSE COULD NOT OPEN THE JAWS. OMENTUM. NOT VERY THICK. THE PATIENT DID NOT HAVE ANY VASCULAR PATHOLOGY OR WAS THE DEVICE ACTIVATED ON DISEASED OR INFLAMED TISSUE (CALCIFIED, SCARRED, ATHEROSCLEROTIC, FIBROTIC, ETC.). NO TENSION APPLIED TO A VESSEL OR TISSUE BUNDLE DURING SEALING. VERY SHORT TIME, LESS THAN 5 MINUTES (5¿8 ACTIVATIONS?). NO, NOT MORE THAN USUAL ESCHAR BUILD UP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23562457 ↗
• MalfunctionJun 4, 2025Failure to Deliver Energy; Output below Specifications; Failure to Deliver Energy; Output below Specifications

  TYPE OF PROCEDURE: BILATERAL SALPINGECTOMY. EVENT DESCRIPTION: EVENT DATE IS UNKNOWN. [ORIGINAL FRENCH TEXT]. AI TRANSLATION: THE ¿VOYANT¿ DM DID NOT WORK (NO COAGULATION). I UNPLUGGED IT THEN PLUGGED IT BACK IN BUT IT HAD NO EFFECT. WE HAD TO OPEN A LAPAROSCOPY BOX SO THAT THE SURGEON COULD USE THE BIPOLAR IN IT TO PERFORM A COAGULATION PROCEDURE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 12MAY25: THE INCIDENT WAS OBSERVED AFTER APPROXIMATELY 10 ACTIVATIONS. THE READY MESSAGE WAS DISPLAYED ON THE GENERATOR WHEN THE DEVICE WAS CONNECTED. NO ALARMS. THE HEARD THE ACTIVATION AND END TONE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 16MAY25: NO BLEEDING OBSERVED DUE TO THE INCIDENT. THE SURGEON DOES NOT REMEMBER WHETHER THEY ACTIVATED THE BLADE AFTER HEARING THE END TONE. PATIENT STATUS: NOTHING TO DECLARE. INTERVENTION: THEY UNPLUGGED AND PLUGGED IT BACK BUT IT HAD NO EFFECT. THEY OPEN A LAPAROSCOPY BOX USE A BIPOLAR. DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142584 ↗
• MalfunctionJul 3, 2024Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: TLH. EVENT DESCRIPTION: [NAME OF HOSPITAL]. [NAME OF SALES DEALER]. THIS IS A COMPLAINT FROM THE MARKET. REPORT FROM THE SALES REP VIA EMAIL; AN ERROR MESSAGE FREQUENTLY DISPLAYED THAT IS NOT RECOGNIZED THE TISSUE. THIS ERROR APPEARED LAST TIME AS WELL. (THE ERROR MESSAGE: "CHECK DEVICE" DESCRIBED IN USER MANUAL PAGE 18, FIGURE 7). THIS UNIT WILL BE RETURNED. PATIENT STATUS: NO CLINICAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670867 ↗
• InjuryMar 5, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: SUBTOTAL GASTRECTOMY. EVENT DESCRIPTION: THEY WERE SEALING AND CUTTING THE TISSUES. DURING THE OPERATION, AFTER THE TISSUES WERE SEALED AND THE CUT WAS MADE, THE BLADE BECAME STUCK ON THE TRIGGER. THIS WAS OBSERVED MORE THAN ONCE. DUE TO THIS SITUATION, THE JAWS COULD NOT BE OPENED AFTER OPENING THE PROBE HANDLE LOCK. ANOTHER PRODUCT WAS USED TO OPEN THE JAWS. IT CAUSED TISSUE DAMAGE AND BLEEDING. THE CASE WAS CONTINUED WITH ANOTHER VOYANT PROBE. ADDITIONAL INFORMATION RECEIVED ON 27 FEBRUARY 2024 BY [DISTRIBUTOR] BY EMAIL: THEY HAVE STANDARD BIPOLAR, MONOPOLAR AND OPEN INSTRUMENTS. THEY STOP BLEEDING STANDARD BIPOLAR THEN SECOND VOYANT PROBE. YES , THEY CUT THE TISSUE WITH SCISSORS. OPERATION SUCCESSFULLY COMPLETED. PATIENT CONDITION IS GOOD. THEY HARDLY PULL THE BLADE LAYER BUTTON(SCRUP NURSE), THEN THE LOCKING MECHANISM IS FREE THEN JAWS OPENED. INTERVENTION: ANOTHER PRODUCT WAS USED TO OPEN THE JAWS. THE CASE WAS CONTINUED WITH ANOTHER VOYANT PROBE. PATIENT STATUS: ONLY LITTLE BLEEDING. OPERATION SUCCESSFULLY COMPLETED. PATIENT CONDITION IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842194 ↗
• MalfunctionJan 15, 2024Failure to Deliver Energy; Energy Output Problem; Failure to Deliver Energy; Energy Output Problem

  PROCEDURE PERFORMED: HYSTERECTOMY WITH LYMPHOIDECTOMY, ABDOMINAL EVENT DESCRIPTION: A LYMPH NODE RESECTION IN LYMPHADENECTOMY AFTER HYSTERECTOMY WAS BEING PERFORMED. THE DEVICE STOPPED WORKING, IT DID NOT SEAL WHEN ACTIVATED. THERE WAS NO CLINICAL IMPACT FOR THE PATIENT. HE FINISHED PERFORMING THE LYMPHADENECTOMY WITH THE LAPAROSCOPY SCISSORS AND THE STANDARD BIPOLAR. NO OTHER INSTRUMENTS WERE BEING USED. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 28JUL23: AS EXPLAINED IN THE CER, LYMPH NODE DISSECTION WAS BEING PERFORMED. THE DEVICE HAD BEEN USED FOR ABOUT AN HOUR AND A HALF, THE CUSTOMER DOES NOT KNOW THE NUMBER OF ACTIVATIONS (APPROX. # OF ACTIVATIONS). THE ACTIVATION TONE AND END TONE WAS HEARD. THERE WERE NO THERMAL EFFECTS. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 30OCT23: THE OPERATING ROOM SUPERVISOR AT THE [USER FACILITY] NOTIFIED ME ON (B)(6) TO PICK UP THE DEFECTIVE DEVICE, SHE INFORMED ME THAT THE SURGERY HAD BEEN ON THE (B)(6) , POSSIBLY SHE WAS CONFUSED WHEN TELLING ME THE DATE AND THE SURGERY WAS PERFORMED ON PREVIOUS WEEK, (B)(6). THE DEVICE IS THE ONE THAT WAS GIVEN TO ME AND THE INFORMATION ABOUT THE EVENT WAS CONF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515097 ↗
• MalfunctionOct 9, 2023Failure to Deliver Energy; Failure to Deliver Energy

  PROCEDURE PERFORMED: VAGINAL HYSTERECTOMY. EVENT DESCRIPTION: [TRANSLATION] DURING A VAGINAL HYSTERECTOMY THE INSTRUMENT NO LONGER "WANTED" TO TIGHTEN THE JAWS. THE SURGEON TRIED TAKING LESS THICK TO SEE IF IT WAS A QUESTION OF TOO THICK A GRIP... IN VAIN, THE JAWS WERE NO LONGER TOUCHING SO INEFFECTIVE, CHANGE OF FORCEPS, NO PROBLEM. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 19SEP2023: SEALING COMPLETED SHOWED ON THE SCREEN. NO ALARMS WERE RECEIVED. NO ERRORS WERE RECEIVED. THE ACTIVATION TONE OR END TONE WAS HEARD WHEN THE FUSE ACTIVATION BUTTON WAS PRESSED. THE JAWS WERE NOT LOCKED. SURGEON TOLD US, THAT IT SHOWED SEALING COMPLETED ON THE SCREEN WITHOUT ANY ELECTRICITY PASSED ALONG (NO SMOKE NO SEALING). ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 12FEB2024: THE CUSTOMER CONFIRMS THAT ¿NO SMOKE, NO SEALING¿ WAS DUE TO ¿THE JAWS NO LONGER TOUCHING.¿ INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17897197 ↗
• InjuryAug 29, 2023Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: WHIPPLE. EVENT DESCRIPTION: PROGRESSIVE STICKING OF THE JAW TO TISSUE. SURGEON PREFERRED TO SWITCH TO NEW DEVICE DUE TO INCREASING STICKINESS. DEVICE JAW WAS CLEANED WITH SHARP INSTRUMENTS AFTER OCCURRENCE OF THE STICKING, BUT WAS NOT USED AFTER. NO PATIENT TISSUE FACTORS KNOWN BEFOREHAND. OPENED A NEW. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 30MAY2023: NO THERE WAS NO BLEEDING, HOWEVER, ACCORDING TO THE SURGEON HE DID NOT FEEL COMFORTABLE TO CONTINUE WORKING WITH THE DEVICE, MAINLY BECAUSE OF THE POTENTIAL RISK OF INSUFFICIENT HEMOSTASIS AND / OR TEARING UP PREVIOUSLY SEALED TISSUE WITH THE AFFECTED DEVICE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 1JUN2023: WE WERE ABLE TO COMPLETE THE OPERATION WITH OTHER INSTRUMENTS WITHOUT DANGER TO THE PATIENT (NEW EB240). WE HAD TO CUT THE VOYANT OUT OF THE TISSUE WITH A DIATHERMY KNIFE. WHEN WE REMOVED THE VOYANT, THE KNIFE WAS STUCK IN A POSITION WHERE IT WAS DISLOCATED OUTSIDE THE JAWS AND THUS HAD NOT GONE BACK. NO TISSUE DAMAGE OR BLEEDING. THE USE WAS IN HARD APONEUROSIS/SCAR TISSUE IN THE ABDOMINAL WALL. THIS WAS OBSERVED ONCE AFTER APPROXIMATELY 2 HOURS AND CI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647374 ↗
• MalfunctionAug 24, 2023Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: EVENT 1 OF 3: (B)(4) [MFR #2027111-2023-00571]. EVENT 2 OF 3: (B)(4). EVENT 3 OF 3: (B)(4). MODEL IS EB15 OR EA020. IT IS UNKNOWN IF A PATIENT INJURY OR ILLNESS OCCURRED. USED ANOTHER HANDPIECE BUT SAME PROBLEM - NO SEALING. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 4AUG23: LOT NO: 1484419, SURGERY: GYN I WILL CHECK UP MORE SPECIFIC. NO PATIENT WAS HURT. THE HOSPITAL HAS KEPT THE HANDLE USED IN THE SURGERY AT THE MEDICO DEPARTMENT. WE DID CALL THE DOCTOR WHO HAVE HAD THE ISSUES, TRYING TO TALK TO HIM. THE NURSE TOLD ME THAT THE DOCTOR IS 70 YEARS OLD, AND WILL LEAVE THE HOSPITAL FOR HIS RETIREMENT/PENSION¿ THERE WAS GENERAL UNDERSTANDING THAT THIS COULD BE THE MAIN ISSUE. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 7AUG23: I HAVE BEEN IN CONTACT WHIT THE DOCTOR [NAME REDACTED] THIS MORNING, HE IS THE ONE USING THE HANDLES. HE INFORMS ME THAT BOTH HANDLES DIDN´T ACTIVATE WHEN HE WAS USING THE ACTIVATE BUTTON. BUT ACTIVATION DID START WHEN HE WAS USING THE KNIFE. I INFORMED HIM THAT WE HAVE TESTED THE 2 HANDLES USED AT THE DEPARTMENT LAST FRIDAY AND WE COULD NOT FIND

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618009 ↗
• MalfunctionAug 24, 2023Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: GYN EVENT DESCRIPTION: EVENT 1 OF 3: (B)(4) EVENT 2 OF 3: (B)(4) [MFR #2027111-2023-00573] EVENT 3 OF 3: (B)(4) [MFR #2027111-2023-00574] MODEL IS EB15 OR EA020. IT IS UNKNOWN IF A PATIENT INJURY OR ILLNESS OCCURRED. USED ANOTHER HANDPIECE BUT SAME PROBLEM - NO SEALING INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 4AUG23: LOT NO: 1484419, SURGERY: GYN I WILL CHECK UP MORE SPECIFIC. NO PATIENT WAS HURT. THE HOSPITAL HAS KEPT THE HANDLE USED IN THE SURGERY AT THE MEDICO DEPARTMENT. I CHECKED THE HANDLE AND GENERATOR, THE NURSE, MEDICO TECHNICIAN AND I DID ALSO TEST THE EB215 HANDLE ON A WET NAPKIN. BOTH HANDLES WERE WORKING FINE ¿ NO PROBLEM AT ALL. WE DID CALL THE DOCTOR WHO HAVE HAD THE ISSUES, TRYING TO TALK TO HIM. THE DOCTOR WAS GONE HOME DUE TO HIS NIGHTSHIFT ENDING. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 7AUG23: I HAVE BEEN IN CONTACT WITH THE DOCTOR [NAME REDACTED] THIS MORNING, HE IS THE ONE USING THE HANDLES. HE INFORMS ME THAT BOTH HANDLES DIDN´T ACTIVATE WHEN HE WAS USING THE ACTIVATE BUTTON. BUT ACTIVATION DID START WHEN HE WAS USING THE KNIFE. I INFORMED HIM THAT WE HAVE TESTED THE 2 HANDLES USED AT T

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17617874 ↗
• MalfunctionAug 23, 2023Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: GYN EVENT DESCRIPTION: EVENT 1 OF 3: 2023-002227 [MFR #2027111-2023-00571] EVENT 2 OF 3: 2023-002271 [MFR #2027111-2023-00573] EVENT 3 OF 3: 2023-002281 [MFR #2027111-2023-00574] MODEL IS EB15 OR EA020. IT IS UNKNOWN IF A PATIENT INJURY OR ILLNESS OCCURRED. USED ANOTHER HANDPIECE BUT SAME PROBLEM - NO SEALING INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 4AUG23: LOT NO: 1484419, SURGERY: GYN I WILL CHECK UP MORE SPECIFIC. NO PATIENT WAS HURT. THE HOSPITAL HAS KEPT THE HANDLE USED IN THE SURGERY AT THE MEDICO DEPARTMENT. I CHECKED THE HANDLE AND GENERATOR, THE NURSE, MEDICO TECHNICIAN AND I DID ALSO TEST THE EB215 HANDLE ON A WET NAPKIN. BOTH HANDLES WERE WORKING FINE ¿ NO PROBLEM AT ALL. WE DID CALL THE DOCTOR WHO HAVE HAD THE ISSUES, TRYING TO TALK TO HIM. THE DOCTOR WAS GONE HOME DUE TO HIS NIGHTSHIFT ENDING. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 7AUG23: I HAVE BEEN IN CONTACT WHIT THE DOCTOR [NAME REDACTED] THIS MORNING, HE IS THE ONE USING THE HANDLES. HE INFORMS ME THAT BOTH HANDLES DIDN´T ACTIVATE WHEN HE WAS USING THE ACTIVATE BUTTON. BUT ACTIVATION DID START WHEN HE WAS USING THE KNIFE. I INFORMED HIM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608362 ↗
• MalfunctionJul 31, 2023Excessive Heating; Excessive Heating

  PROCEDURE PERFORMED: WIDE LOCAL INCISION EVENT DESCRIPTION: DEVICE WAS BEING USED TO SEAL AND CUT BREAST TISSUE. EB217 WAS BEING USED IN THE INCISION TO SEAL BREAST TISSUE, THE PLASTIC SHAFT OF VOYANT WAS LENT AGAINST THE SKIN NEXT TO THE INCISION, WHEN THE SHAFT WAS MOVED TO THE OTHER SIDE OF THE INCISION TO SEAL DIFFERENT BREAST TISSUE, IT WAS NOTICED THAT THERE WAS A SMALL BURN MARK ON THE SKIN, CAUSED BY THE SHAFT OF VOYANT. IT CAUSED A SMALL SUPERFERICAL BURN. SMALL SUPERFICIAL BURN, SHOULD RECOVER NORMALLY. CONTINUED TO USE TO THE REMAINDER TO THE CASE. INTERVENTION: CONTINUED TO USE TO THE REMAINDER TO THE CASE PATIENT STATUS: SMALL SUPERFICIAL BURN, SHOULD RECOVER NORMALLY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 17431145 ↗
• MalfunctionJun 5, 2023Excessive Heating; Excessive Heating

  PROCEDURE PERFORMED: WIDE LOCAL EXCISION + NODE BIOPSY. EVENT DESCRIPTION: A CREST SHAPED (OUTLINE OF THE VOYANT SHAFT) BURN MARK WAS NOTICED IMMEDIATELY AFTER THE SHAFT OF THE DEVICE HAD COME INTO CONTACT WITH THE AREOLA. THE SHAFT OF DEVICE WAS LAID ACROSS THE PATIENTS AREOLA, HANDLE TOWARDS THE FEET AND JAWS TOWARDS THE HEAD, TO GAIN ACCESS TO AN AREA OF SUPERIOR BREAST TISSUE. BOTH THE DEVICE AND AREOLA WERE WET.  INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 31MAY23: PATIENT IS FINE, IT WAS A VERY SUPERFICIAL BURN SO NO ADDITIONAL ACTION NEEDED. MR [NAME REDACTED] TRIES TO KEEP THE VOYANT SHAFT OFF THE SKIN AS HE HAS EXPERIENCED SIMILAR EVENTS PREVIOUSLY. THE OTHER INSTRUMENTS THAT ARE USED AROUND THE INCISION ARE: MONOPOLAR PENCIL, BIPOLAR FORCEPS AND LANGENBECK RETRACTORS. NEITHER THE MONOPOLAR PENCIL OR BIPOLAR FORCEPS WERE SEEN TO COME INTO CONTACT WITH THIS AREA OF SKIN. INTERVENTION: IT WAS A VERY SUPERFICIAL BURN SO NO ADDITIONAL ACTION NEEDED. MR [NAME REDACTED] TRIES TO KEEP THE VOYANT SHAFT OFF THE SKIN AS HE HAS EXPERIENCED SIMILAR EVENTS PREVIOUSLY. PATIENT STATUS: PATIENT IS FINE, IT WAS A VERY SUPERFICIAL BURN SO NO ADDITIONAL ACTION NEEDED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 17065993 ↗
• MalfunctionMay 12, 2023Excessive Heating; Excessive Heating

  PROCEDURE PERFORMED: BILATERAL WIDE LOCAL EXCISION. EVENT DESCRIPTION: IT WAS NOTICED DURING THE CASE THAT THERE WAS A RED MARK (POTENTIAL BURN) ON THE AREOLA NEXT TO THE INCISION. THE SURGEON MADE SURE THAT THE VOYANT JAWS / METAL SECTION BETWEEN JAWS AND PLASTIC SHAFT WERE NOT IN CONTACT WITH THIS SECTION OF SKIN AT ANY POINT DURING THE CASE. THE ONLY PART OF THE VOYANT DEVICE THAT CAME INTO CONTACT WITH THE SKIN WAS THE PLASTIC SHAFT. [SURGEON NAME REDACTED] HAS SEEN THESE RED MARKS PREVIOUSLY WHEN USING EB217 AND IS VERY CAREFUL TO MINIMIZE ANY CONTACT BETWEEN VOYANT AND THE SKIN. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 5MAY23: PATIENT IS FINE, IT WAS A VERY SUPERFICIAL BURN SO NO ADDITIONAL ACTION NEEDED. [SURGEON NAME REDACTED] TRIES TO KEEP THE VOYANT SHAFT OFF THE SKIN AS HE HAS EXPERIENCED SIMILAR EVENTS PREVIOUSLY. THE OTHER INSTRUMENTS THAT ARE USED AROUND THE INCISION ARE: MONOPOLAR PENCIL, BIPOLAR FORCEPS AND [BRAND NAME REDACTED] RETRACTORS. NEITHER THE MONOPOLAR PENCIL OR BIPOLAR FORCEPS WERE SEEN TO COME INTO CONTACT WITH THE SKIN. [SURGEON NAME REDACTED] HAS NOTICED MARKS AROUND THE INCISION WITH ONLY THE EB217 SINCE OCTOBER 2

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16920637 ↗
• InjuryMar 22, 2023Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: ABDOMINAL SARCOMA EVENT DESCRIPTION: [TRANSLATION] THE JAWS OF THE DEVICE REMAINED BLOCKED, IMPOSSIBLE TO OPEN IT AFTER HAVING COAGULATED. WE WERE FORCED TO PUT IN ANOTHER DEVICE TO CUT THE VESSEL AND PERFORMED A SCISSOR CUT. THIS PROBLEM CAUSED AN EXTENSION OF THE INTERVENTION AND A REAL RISK FOR THE PATIENT. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 18MAR23: ABDOMINAL SARCOMA. PATIENT OK. DATE OF THE EVENT: 18MAR23. BIPOLAR FORCEPS, ELECTROCAUTERY WERE USED. THE JAWS REMAINED BLOCKED AFTER THE COAGULATION STEP, THERE HAD BEEN NO DIFFICULTIES WITH THE BLADE BEFORE. THE TISSUES WERE SECTIONED AND THEN THE JAWS WERE FORCED TO BE OPENED THERE WAS NO ASSOCIATED BLEEDING. THE INCIDENT ONLY TOOK PLACE ONCE. THEY TOOK ANOTHER EB217. THIS HAPPENED AT THE BEGINNING OF THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 5JUN23: THE EB217 SENT BACK IS THE GOOD ONE AND IT WAS ON THE (B)(6) 2023 INTERVENTION: WE WERE FORCED TO USE ANOTHER CLAMP TO CUT THE VESSEL AND PERFORMED A SECTION WITH SCISSORS. DEVICE REPLACEMENT. PATIENT STATUS: THIS PROBLEM RESULTED IN A LONGER PROCEDURE AND A REAL RISK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594653 ↗
• InjuryDec 5, 2022Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: WIDE LOCAL EXCISION EVENT DESCRIPTION: IT WAS NOTICED DURING THE CASE THAT THERE WAS A SIGNIFICANT RED MARKS (POTENTIAL BURN) TO THE SKIN NEXT TO THE INCISION UNDER THE ARMPIT AND ANOTHER SIGNIFICANT RED MARKS (POTENTIAL BURN ON THE AREOLA NEXT TO THE INCISION. THE SURGEON MADE SURE THAT THE VOYANT JAWS / METAL SECTION BETWEEN JAWS AND PLASTIC SHAFT WERE NOT IN CONTACT WITH THIS SECTION OF SKIN AT ANY POINT DURING THE CASE. THE ONLY PART OF THE VOYANT DEVICE THAT CAME INTO CONTACT WITH THE SKIN WAS THE PLASTIC SHAFT. THEY WERE TAKING THE SENTINEL NODES AT THE TIME THE MARK WAS SEEN ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM TERRITORY MANAGER ON (B)(6) 2022: THERE WERE TWO MARKS NOTICED, ONE ON THE AREOLA NEXT TO THE INCISION ROUGHLY 4MM WIDE X 8MM LONG AND ONE NEXT TO THE INCISION IN THE ARMPIT ROUGHLY 4MM WIDE X 8MM LONG ADDITIONAL INFORMATION PROVIDED BY TERRITORY MANAGER VIA EMAIL (B)(6) 2022: I SPOKE WITH [SURGEON] AND THE PATIENT IS FINE, NOTHING FURTHER NEEDED TO DO DONE, AS THE BURNS WERE SUPERFICIALLY AND HEALED NATURALLY. INTERVENTION: NOTHING FURTHER NEEDED TO BE DONE, AS THE BURNS WERE SUPERFICIALLY AND HEALED NATURALLY. PATIENT STATUS: PATIENT I

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15916714 ↗
• MalfunctionNov 14, 2022Failure to Deliver Energy; Failure to Deliver Energy

  PROCEDURE PERFORMED: PANCREATICODUODENECTOMY. EVENT DESCRIPTION: SEALING AND CUTTING ACTION WAS BEING PERFORMED WHEN THE EVENT OCCURRED. THE DEVICE DOES NOT WORK WHEN ACTIVATING THE SEALING SWITCH, SEALING DOES NOT OCCUR. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 3NOV2022: THE READY MESSAGE WAS DISPLAYED ON THE SCREEN WHEN THE DEVICE WAS CONNECTED. THEY DID NOT RECEIVE ANY ALARMS. THE ACTIVATION TONE OR END TONE WAS HEARD WHEN THE FUSE ACTIVATION BUTTON WAS PRESSED. THERMAL EFFECTS WERE NOT VISIBLE AT THE SEAL SITE. PERITONEUM SECTION WAS BEING GRASPED WHEN THE EVEN HAPPENED. THE DEVICE HAD BEEN USED FOR 20-25 ACTIVATIONS BEFORE THE EXPERIENCE WAS OBSERVED. INTERVENTION: REPLACING THE DEVICE WITH A NEW ONE. PATIENT STATUS: FAVORABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794428 ↗
• InjuryOct 31, 2022Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: HIPEC. EVENT DESCRIPTION: HIPEC - RESECTION AND REMOVAL OF MESENTERIC ROOT NODULE - RESECTION AND REMOVAL OF THE ANTERIOR QUADRANT OF THE GREATER OMENTUM AND PREVIOUS SCAR - RESECTION AND REMOVAL OF ILIOCECAL VALVE IMPLANT -RESECTION AND REMOVAL OF THE LEFT COLON SEGMENT. AFTER 4 HOURS FROM THE START OF SURGERY, THE JAW OF THE DEVICE BEGINS TO LOCK, THE SURGEON SEALS, CUTS AND REMOVES THE DEVICE FROM THE TISSUE, BUT DOES NOT ACHIEVE COMPLETE OPENING OF THE TIPS, AFTER SEVERAL ATTEMPTS TO OPEN AND CLOSE THE JAW. HANDLE OF THE DEVICE, FINALLY THE JAW IS COMPLETELY LOCKED AND TO UNLOCK IT THE SURGEON HAS TO MAKE SEVERAL ATTEMPTS TO OPEN AND CLOSE, ALL THIS HAPPENS WITHOUT HAVING TISSUE IN THE JAW. DUE TO THE DIFFICULTY OF PERFORMING THE SURGERY AND FOR SAFETY REASONS, THE SURGEON REQUESTED A NEW EB217 DEVICE. AFTER 1 HOUR OF USE, THE DEVICE BECAME BLOCKED WITH THE TISSUE BETWEEN ITS JAWS, THE SURGEON SEALED, CUT AND COULD NOT OPEN THE JAW, PERFORMED THE OPENING ACTION AND THE DEVICE DID NOT RESPOND TO THE OPENING AND CLOSING MANEUVER. TO RELEASE THE OMENTUM TISSUE FROM THE MANDIBLE OF THE DEVICE, HE MANUALLY CUTS IT WITH SCISSORS AND SUTURES THE ENDS. THE SURGERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699044 ↗
• InjuryOct 29, 2022Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: WIDE LOCAL EXCISION. EVENT DESCRIPTION: IT WAS NOTICED DURING THE CASE THAT THERE WERE A FEW SIGNIFICANT RED MARKS (POTENTIAL BURN) TO THE SKIN NEXT TO THE INCISION UNDER THE ARMPIT. THE SURGEON MADE SURE THAT THE VOYANT JAWS / METAL SECTION BETWEEN JAWS AND PLASTIC SHAFT WERE NOT IN CONTACT WITH THIS SECTION OF SKIN AT ANY POINT DURING THE CASE. THE ONLY PART OF THE VOYANT DEVICE THAT CAME INTO CONTACT WITH THE SKIN WAS THE PLASTIC SHAFT. THEY WERE TAKING THE SENTINEL NODES AT THE TIME THE MARK WAS SEEN. UNFORTUNATELY, THE CABLE WAS CUT OFF THE DEVICE SO WAS NOT ABLE TO BE RETURNED. I WAS NOT ALLOWED TO TAKE A PICTURE (TRUST POLICY) OF THE MARKS, BUT I HAVE DRAWN A DIAGRAM OF WHAT IT LOOKED LIKE. THE LARGER INCISION IS 2MM WIDE X 12MM LONG AND THE 2 SMALLER MARKS WERE 3MM WIDE X 4MM LONG. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 18OCT22: PATIENT IS OKAY, THE SURGEON COULDN¿T REALLY RESOLVE THE SITUATION, THEY CLOSED THE INCISION AS NORMAL AND THE INJURY/MARK WILL NEED TO LOOKED AT TO MAKE SURE IT DOESN¿T GET ANY WORSE. INTERVENTION: THE SURGEON COULDN¿T REALLY RESOLVE THE SITUATION, THEY CLOSED THE INCISION AS NORMAL AND TH

  Patient problems: Burn(s)

  MAUDE report 15696972 ↗
• InjuryOct 29, 2022Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: WIDE LOCAL EXCISION. EVENT DESCRIPTION: IT WAS NOTICED AT THE END OF THE CASE THAT THERE WAS A SIGNIFICANT RED MARK (POTENTIAL BURN) TO THE SKIN NEXT TO THE INCISION UNDER THE ARMPIT. THE JAWS /METAL SECTION BETWEEN JAWS AND PLASTIC SHAFT WERE IN CONTACT WITH THIS SECTION OF SKIN AT SOME POINTS DURING THE CASE, INCLUDING TIMES WHEN THE ENERGY WAS ACTIVATED. THIS SECTION OF SKIN WAS SUBSEQUENTLY REMOVED TO ALLOW FOR HEALTH SKIN TO BE USED TO CLOSE THE INCISION. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 13-OCT-2022: THE PATIENT IS OKAY, THE DAMAGED SKIN WAS REMOVED AND THE WOUND SUTURED CLOSED AS NORMAL. THE LOT NUMBER IS: 1449493. THE SURGEON WAS SEALING AND DIVIDING THE FATTY TISSUE AROUND CLOSE TO THE LYMPH NODES WITH MOST OF THE JAWS INSIDE THE INCISION AND A SMALL AMOUNT OF THE JAW RESTING ON THE SKIN NEXT TO THE INCISION. INTERVENTION: THE DAMAGED SKIN WAS REMOVED AND THE WOUND SUTURED CLOSED AS NORMAL. PATIENT STATUS: THE PATIENT IS OKAY.

  Patient problems: Burn(s)

  MAUDE report 15695154 ↗
• MalfunctionOct 24, 2022Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: EXPLORATORY LAPAROTOMY- GYNECOLOGY. EVENT DESCRIPTION: THE DEVICE WAS BEING USED TO SEAL AND DIVIDE VESSEL AND TISSUE IN THE ABDOMINAL CAVITY DURING THE SURGERY. AFTER 3 HOURS AND 15 MINUTES SURGERY THE SURGEON FELT THAT THE HEMOSTASIS OF VOYANT WASN´T GOOD ENOUGH. ADDITIONAL INFORMATION VIA EMAIL RECEIVED BY APPLIED MEDICAL REP ON 25OCT22: THE PATIENT WASN'T ADMITTED TO THE ICU AS A RESULT OF THIS INCIDENT. THE PATIENT HAS BEEN DISCHARGED FROM THE ICU. THE GENERATOR MADE THE END-TONE SIGNAL. THE SURGEON DID ACTIVATE THE BLADE AFTER HEARING THE END TONE. NOT SURE IF THERE WAS BLEEDING SINCE IT WAS IN A PLACE WITH A LOT OF PRESSURE FROM AORTA. ADDITIONAL INFORMATION VIA EMAIL RECEIVED BY APPLIED MEDICAL REP ON 10JAN23: THE DOCTOR IS NO LONGER EMPLOYED AT THIS HOSPITAL AND IT IS THEREFORE NOT POSSIBLE FOR ME TO GET ADDITIONAL INFORMATION. INTERVENTION: THE SURGEON CHANGE VOYANT WITH THUNDERBEAT FOR SEALING AND DIVIDING TISSUE AND VESSELS PATIENT STATUS: AFTER THE SURGERY THE PATIENT WENT FOR OBSERVATION AT THE ICU - UPDATE 25OCT22: THE PATIENT HAS BEEN DISCHARGED FROM THE ICU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663883 ↗
• MalfunctionAug 31, 2022Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: OPEN LEFT COLECTOMY. EVENT DESCRIPTION: EVENT OCCURRED DURING AN EVALUATION (TM PRESENT). THE DEVICE WORKED WELL THE MAJORITY OF THE SURGERY, BEING CLEANED PROPERLY VERY OFTEN (INCLUDING THE BLADE RAIL), HOWEVER, CLOSE TO THE END OF THE PROCEDURE THE JAWS STARTED STICKING WITH MORE INTENSITY, EVEN RIGHT AFTER CLEANING THEM. IN TWO OCCASIONS THE SURGEON COULDN'T OPEN THE JAWS AFTER SEALING THE TISSUES, STATING THAT THE BLADE WAS NOT RETRACTING TO THE HOME POSITION. IN BOTH CASES THE SURGEON HAD TO CUT THE SEALED TISSUES WITH A SCALPEL TO RELEASE THE JAWS (NO IMPLICATIONS). THE SECOND TIME IT BLOCKED OCCURRED AFTER A FEW ACTIVATIONS FROM THE FIRST TIME (AROUND 10 ACTIVATIONS AFTER A DEEP CLEANING). JUST AROUND 5 ACTIVATIONS FROM THE SECOND EPISODE UNTIL THE END OF THE SURGERY. INTERVENTION: NI. PATIENT STATUS: EVENT WITH NO CLINICAL IMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332352 ↗
• MalfunctionAug 9, 2022Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: OPEN PANCREATECTOMY. EVENT DESCRIPTION: IT WAS BEING USED FOR DISSECTION AND SEALING VESSELS AND TISSUES. AT THE BEGINNING OF THE PROCEDURE, AFTER A FEW ACTIVATIONS ( 15 OR SO ) THE FUSION BUTTON GOT STUCK, AND THE HANDPIECE STOPPED WORKING. IN THE GENERATOR´S SCREEN WAS THE MESSAGE " CHECK FOR STUCK BUTTON " INTERVENTION: THE OR STAFF REPLACED OUR HANDPIECE FOR A COMPETITOR´S ONE. PATIENT STATUS: NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195822 ↗
• MalfunctionApr 16, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PROCEDURE PERFORMED: OPEN TOTAL PANCREATECTOMY. DESCRIPTION: BOTH SURGEONS WERE USING EB217 WITHOUT ANY ISSUES UNTIL APPROXIMATELY 2 HOURS OF INTERVENTION. AT THAT POINT, WHILE SEALING LYMPHATIC TISSUE SURROUNDING THE SPLENIC ARTERY, THE JAWS GOT STICKED TO THE TISSUE. THEY OPENED THE JAWS AND CLOSE THEM AGAIN TRYING TO SEAL AND CUT AGAIN. THE TISSUE WOULD STILL GET STICKED MAKING IT IMPOSSIBLE TO SEPARATE THEM FROM THE TISSUE. IN ORDER TO BE ABLE TO SEPARATE THE TISSUE FROM THE JAWS, THEY HAD TO USE THE MONOPOLAR PENCIL AND CUT THE TISSUE SURROUNDING THE JAWS. THEY TRIED TO SEAL SOME SHORT VESSELS AROUND THE STOMACH AFTERWARDS AND TISSUE GOT ALSO STICKED. NOT TO THE POINT WHERE THEY HAD TO USE THE MONOPOLAR, BUT THEY HAD TO ROTATE THE SHAFT TO LIBERATE THE TISSUE. FROM THAT POINT ONE, THEY USED SOME COMPETITOR DEVICE. ONE HOUR AFTER USING THE COMPETITOR DEVICE (3 HOURS OF INTERVENTION MORE OR LESS), THEY TRIED ONCE AGAIN USING EB217 ON MESENTERY TISSUE SURROUNDING THE SMALL INTESTINE. AGAIN, TISSUE GOT STICKED AND THEY ALLOWED ME RECORDING A COUPLE OF VIDEOS OF THAT MOMENT. IF YOU WANT THE VIDEOS, LET ME KNOW. THEY ALSO MENTIONED THE FEELING OF THE TRIGGER CHANGED AS THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681783 ↗