Voyant Maryland Fusion Device with Single-Step Activation EB212Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00607915140793), received between Apr 5, 2023 and Sep 19, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Patient-Device Incompatibility; Mechanical Jam; Patient-Device Incompatibility; Mechanical Jam

  PROCEDURE PERFORMED: SENTINEL NODE BIOPSY AND LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: LAPAROSCOPIC SENTINEL NODE BIOPSY PRIOR TO HYSTERECTOMY. AFTER 68 ACTIVATIONS, WHILE SEALING THE UTERINE ARTERY, THE JAWS OF THE VOYANT BECAME ADHERED TO THE VESSEL AND COULD NOT BE REMOVED. USING MONOPOLAR AND ENDOCLIPS TO STABILISE THE VESSEL, THE JAWS WERE PEELED OFF THE TISSUE. SURGEON THEN REQUESTED [COMPETITOR DEVICE] TO COMPLETE THE SURGERY. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM, AMNZ SENIOR TERRITORY MANAGER VIA EMAIL ON 26-AUG-2025: "FURTHER INFORMATION PERTAINING TO THE DEVICE INVOLVED IN THIS CER: LOT#: 1549569. SERIAL#: (B)(6). ADDITIONAL INFORMATION WAS RECEIVED FROM, AMNZ SENIOR TERRITORY MANAGER VIA EMAIL ON 04-SEP-2025: "NO, WHEN THE JAWS BECAME ADHERED TO THE TISSUE, THEY COULD NOT REMOVE THE DEVICE. THEY THEN USED ENDOCLIPS TO STABILIZE THE VESSEL AND MONOPOLAR TO PEEL OFF THE VOYANT JAWS." PATIENT STATUS: STABLE. INTERVENTION: USING MONOPOLAR AND ENDOCLIPS TO STABILISE THE VESSEL, THE JAWS WERE PEELED OFF THE TISSUE. SURGEON THEN REQUESTED [COMPETITOR DEVICE] TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096411 ↗
• MalfunctionJun 30, 2025Self-Activation or Keying; Difficult to Open or Close; Self-Activation or Keying; Difficult to Open or Close

  PROCEDURE PERFORMED: LAP LYMPHADENOTOMY, HYSTERECTOMY, ADNEXECTOMY EVENT DESCRIPTION: STERILE ITEM FROM TM SCRUB STOCK FOR EVALUATION NORMAL APPLICATIONS AND SEALING DURING PROCEDURE. WHEN CLOSING THE INSTRUMENT A LOUD CRACKING WAS HEARD. AFTERWARDS THERE WAS NO RESISTANCE WHEN THE INSTRUMENT WAS CLOSED. THE INSTRUMENT DID NOT OPEN AUTOMATICALLY ANYMORE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 20JUN25: THE REP BROUGHT THE INSTRUMENT TO THE OR FROM HIS PERSONAL SCRUB STOCK. IT DID NOT LOCK. THE LOUD CRACKING HAPPENED DURING NORMAL USE. JAW STILL MOVES BUT THERE IS NO "GRASPING ZONE" ANYMORE AND DOES NOT OPEN AUTOMATICALLY ANYMORE. NO AUDIBLE OR VISUAL DAMAGE PRIOR TO THE INCIDENT. APPROX. 50 TIMES (LYMPHADECTOMY FINISHED, ADNEXECTOMY ON ONE SIDE, HYSTERECTOMY STARTED). THERE WAS NO THICK OR TENSE TISSUE. THERE WERE SOME ACCIDENTALLY SHORT ACTIVATIONS BECAUSE THE SURGEON WAS USED TO PRESS THE HANDLE TO OPEN IT WITH EB215 AND DID ACCIDENTALLY SO WITH THE NEW SINGLE STEP EB212. NO LOCK, NO TISSUE DAMAGE OR BLEEDING. THE BLADE LEVER WAS ABLE TO SPRING BACK INTO POSITION/RETURN TO POSITION AUTOMATICALLY. PATIENT STATUS: GOOD INTERVENTION: INSTRUMENT REPLACED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22363780 ↗
• MalfunctionJun 25, 2025Self-Activation or Keying; Failure to Cut; Self-Activation or Keying; Failure to Cut

  PROCEDURE PERFORMED: ADRENALECTOMY LAP EVENT DESCRIPTION: HE WAS WORKING NORMALLY, PICKING AND SEALING TISSUE. WHEN ACTIVATING THE BLADE, IT DID NOT CUT THE TISSUE CORRECTLY AND WHEN REPEATEDLY ACTIVATING IT TO CUT, THE SEALING ALARM WAS ACTIVATED BY MISTAKE. PATIENT STATUS: CORRECT. INTERVENTION: DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333018 ↗
• MalfunctionJun 13, 2025Mechanical Jam; Mechanical Jam

  TYPE OF PROCEDURE: HYSTERECTOMY V-NOTES. EVENT DESCRIPTION: I WAS SEALING THE UTERINE PARAMETRIA. THE DOCTOR HAD MADE ABOUT 20 SEALS WHEN, AFTER THE LAST ACTIVATION, THE BLADE GOT STUCK INSIDE THE JAWS AND THE JAWS COULD NEITHER OPEN NOR CLOSE. THE BLADE WAS LOCKED AND THE JAWS WERE LOCKED AS WELL. NO HARM TO THE PATIENT. VOYANT DID THE LAST ACTIVATION CORRECTLY AND THEN STOPPED OPENING THE JAW TO BE ABLE TO CONTINUE USING IT. THEY OPENED A [COMPETITOR DEVICE] AND CONTINUED WITH THE SURGERY. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 20MAY2025: THE BATCH NUMBER IS CORRECT. IT'S A PINCER THAT I HAD ORDERED IN ORDER TO BE ABLE TO TEST THE PRODUCT. IT SOUNDED LIKE A STRANGE NOISE THAT IT WASN'T KNOWN WHERE IT WAS COMING FROM. NO VASCULAR PATHOLOGY. IN FACT THE SURGEON DID NOT COMPLAIN AT ANY TIME. WHEN IT GOT STUCK, IT WAS DEFINITIVE. THE JAW GOT STUCK WITH THE BLADE HALFWAY THROUGH. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27MAY2025: THE JAWS WERE LOCKED CLOSED AND THE JAWS WERE NOT LOCKED AROUND THE TISSUE; IT COAGULATED, CUT AND RELEASED FROM THE TISSUE. BUT THE JAWS REMAINED LOCKED. THEY OPENED ANOTHER CLAMP, [BRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207352 ↗
• MalfunctionJun 5, 2025Mechanical Jam; Mechanical Jam

  PROCEDURE: MYOMECTOMY. EVENT DESCRIPTION: THERE HAVE BEEN TWO INCIDENTS DURING THE SURGERY: 1. THE SCISSORS STOPPED CUTTING AFTER APPROXIMATELY 20 MINUTES OF OPERATION. WHEN I TRIED TO ACTIVATE IT, IT WOULD NOT ACTIVATE. AFTER PRESSING SEVERAL TIMES, IT ACTIVATED AGAIN. 2. LATER THE JAWS REMAINED CLOSED, BLOCKED AND COULD NOT BE OPENED. AT THIS POINT THE SURGEON DECIDED TO CHANGE THE FORCEPS AND USE A NEW ONE. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT. INTERVENTION: DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152939 ↗
• MalfunctionJun 3, 2025Mechanical Jam; Mechanical Jam

  TYPE OF PROCEDURE: LAPAROSKOPIC HYSTERECTOMY. EVENT DESCRIPTION: VOYANT MARYLAND SINGLE STEP WAS USED DURING A LAPAROSCOPIC HYSTERECTOMY. AFTER 90 ACTIVATIONS THE HANDLE LOCKED ITS SELVES. JAWS WAS UNABLE TO OPEN AND THE KNIFE WAS NOT ABLE TO BE ACTIVATED. BACK BLEEDING FROM UTERUS WAS STOPPED BY USING BIPOLAR GRASPER. VOYANT WAS NOT USED DURING THIS. LAST TIME, BEFORE THE EVENT OCCURRED, I SAW THE INNER JAWS WAS FINE AND CLEAN. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 30MAY25: THE TM ATTENDED THE SURGERY, NO AUDIO OR VISUAL DAMAGE. YES, HANDLE WAS UNRESPONSIVE. I DID TRY IT TOO AFTER IT WAS OFF THE PATIENT. I ASSUME THAT I WOULD BREAK THE HANDLE IF I USED MORE FORCE. BLADE WAS NOT RESPONDING WHEN ACTIVATING IT. BLADE WAS IN NEUTRAL POSITION. NO, THE JAWS WERE NOT LOCKED ONTO THE TISSUE, THE SURGEON TRIED TO REACH TISSUE, BUT THE HANDLE WAS NOT RESPONDING. NO TISSUE WAS DAMAGED DURING THE BREAK DOWN. THIS IS THE ONLY ONE OBSERVED AS I HAVE ATTENDED TO SOME 8 SINGLE STEP SURGERIES AFTER THIS. HANDLE WAS NOT RESPONDING. I DID ASK THE SURGEON TO CLOSE THE HANDLE AND USE THE BLADE LEVER. ALSO RELEASING THE HANDLE ¿ NOTHING HAPPENED. AS THIS WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136813 ↗
• InjuryFeb 10, 2025Excessive Heating; Excessive Heating

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME] NOTES ON FEEDBACK 7428: SURGEON STATED OUTSIDE OF JAW WAS QUITE HOT - ACCIDENTALLY NICKED THE BLADDER AND SURGEON REPORTED LEFT SLIGHT SINGE. NO ADVERSE OUTCOME FOR PATIENT. DEVICE ALSO STUCK AROUND IP - STICKINESS WAS ON THE JAW EDGE. SURGEON NOTED THAT WHEN SEALING AND TRANSECTING, CUT LENGTH WASN'T CONSISTENT - SOMETIMES SHORTER. DESCRIPTION OF EVENT: SEALING AND DIVIDING TISSUE AS PART OF HYSTERECTOMY PROCEDURE. SURGEON STATED OUTSIDE OF JAW WAS QUITE HOT - ACCIDENTALLY NICKED THE BLADDER AND SURGEON REPORTED LEFT SLIGHT SINGE. NO ADVERSE OUTCOME FOR PATIENT. DEVICE ALSO STUCK AROUND IP - STICKINESS WAS ON THE JAW EDGE. SURGEON NOTED THAT WHEN SEALING AND TRANSECTING, CUT LENGTH WASN'T CONSISTENT - SOMETIMES SHORTER. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. THE USER RESOLVED THE SITUATION WITH NO CHANGE TO PROCEDURE, CONTINUED WITH DEVICE THROUGHOUT WHOLE PROCEDURE AND COMPLETED THE PROCEDURE SUCCESSFULLY. TYPE OF INTERVENTION: NO CHANGE TO PROCEDURE, CONTINUED WITH DEVICE THROUGHOUT WHOLE PROCEDURE AND COMPLETED PROCEDURE SUCCESSFULLY. PATIENT STATUS: RECOVERED WELL.

  Patient problems: Burn(s)

  MAUDE report 21344952 ↗
• MalfunctionDec 6, 2024Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  PROCEDURE PERFORMED: [ROBOT-ASSISTED GASTRECTOMY] EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME] REPORT FROM THE SALES REP VIA EMAIL; THE KNIFE OF THE HANDPIECE HAD POPPED OUT WHEN THE PACKAGE WAS OPENED. THE PERSON IN CHARGE OF OPENING THE PACKAGE WAS ALMOST INJURED. THIS UNIT WILL BE RETURNED. THE INVESTIGATION REPORT HAS BEEN REQUESTED BY THE HOSPITAL. AMJ ALWAYS SELLS MEDICAL DEVICES TO SALES DEALERS, THEN THE DEALER SELLS THEM TO HOSPITALS. PER AMJ OPERATION TEAM, THE DEVICE WAS PURCHASED THROUGH A SALES DEALER. THE LOT TRACE WAS PERFORMED USING ACCOUNT ID (B)(4). TYPE OF INTERVENTION: [REPLACED TO A HOSPITAL INVENTORY NEW PRODUCT AND THE PROCEDURE WAS COMPLETED.] PATIENT STATUS: [NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20870118 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC HAND-ASSISTED DONOR NEPHRECTOMY EVENT DESCRIPTION: EB212 JAWS GOT HOT AND BURNED THE BACK OF KIDNEY. HANDLE WAS REPORTED TO NOT FEEL CORRECT, AND FELT LOCKED OUT PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 29MAR2023 VIA EMAIL FROM ACCOUNT MANAGER: THE BURN OCCURRED IMMEDIATELY AFTER FIRING ON ADJACENT TISSUE. THE DEVICE HAD BEEN USED FOR APPROXIMATELY 10 ACTIVATIONS BEFORE THE EXPERIENCE WAS OBSERVED. NO GENERATOR ALARMS OCCURRED. THE JAWS OF THE DEVICE WERE CLEANED EVERY 10-15 ACTIVATIONS. NO AUDIBLE NOISE OR VISUAL DAMAGE WAS OBSERVED TO THE DEVICE PRIOR TO THE HANDLE FEELING LOCKED OUT. PHYSICIAN REPORTS THROUGHOUT THE CASE THE DEVICE FELT DIFFERENT, HARDER TO CLOSE JAWS AND ACTIVATE. ADDITIONAL INFORMATION RECEIVED ON 31MAR2023 VIA EMAIL FROM ACCOUNT MANAGER: NO INTERVENTION NEEDED FOR THE BURN. TYPE OF INTERVENTION: OPENED NEW EB212, COMPLETED SUCCESSFULLY. NO INTERVENTION NEEDED FOR THE BURN. PATIENT STATUS: CASE COMPLETED.

  Patient problems: Burn(s)

  MAUDE report 16683305 ↗