Voyant Maryland Fusion Device with Single-Step Activation EB213Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915140809), received between May 10, 2023 and Apr 29, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Self-Activation or Keying; Mechanical Jam; Self-Activation or Keying; Mechanical Jam

  PROCEDURE PERFORMED: GASTRIC SLEEVE CASE.EVENT DESCRIPTION:THE GENERATOR DISPLAYED AN ERROR CODE THAT SAID, "STUCK BUTTON."ADDITIONAL INFORMATION OBTAINED FROM ACCOUNT MANAGER VIA EMAIL ON 09APR2025:THE HAND PIECE WAS PLUGGED IN AND WHEN THEY WENT TO USE IT IN THE FIRST ACTIVATION, THE GENERATOR SAID BUTTON STUCK AND THEY COULD NOT RELEASE THE DEVICE JAWS. SO, THEY USED AND OPENED ANOTHER ONE. THEY HAVE NOT SEEN THIS HAPPEN BEFORE.ADDITIONAL INFORMATION OBTAINED FROM ACCOUNT MANAGER VIA EMAIL ON 09APR2025:THE GENERATOR WAS NOT TURNED OFF AND ON AGAIN. THEY HEARD THE TONE AS USUAL AND WENT TO USE IT AND GOT THE ERROR AND IT WOULD NOT WORK. IT WAS A GASTRIC SLEEVE CASE.INTERVENTION: OPENED ANOTHER DEVICE.PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21929020 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: GASTRIC SLEEVE SURGERY. EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME]. DOCTOR MENTIONED THAT HE WAS DOING A PROCEDURE FOR A PATIENT ABOUT A MONTH AGO AND THEY DID NOT REALIZE THAT SOMETHING HAPPENED TO THE PATIENT UNTIL AFTER THE TREATMENT. THE PATIENT WAS BLEEDING AND THEY HAD TO REOPEN THE PATIENT AFTER THE PROCEDURE. TYPE OF INTERVENTION: REOPENED PATIENT AFTER PROCEDURE. PATIENT STATUS: PATIENT WAS BLEEDING AFTER PROCEDURE; CURRENTLY THE PATIENT IS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 21149863 ↗
• MalfunctionDec 14, 2023Device Alarm System; Self-Activation or Keying; Device Alarm System; Self-Activation or Keying

  PROCEDURE PERFORMED: LAPAROSCOPIC MODIFIED DUODENAL SWITCH. EVENT DESCRIPTION: DR. [NAME] PERFORMED A MODIFIED DUODENAL SWITCH USING THE VOYANT MARYLAND SINGLE STEP. THE SEAL ACTIVATION BUTTON GOT STUCK AND A NEW DEVICE HAD TO BE OPENED. IT WAS NOTED THAT AN ERROR MESSAGE WAS PRESENT ON THE GENERATOR AS WELL, BUT THE SPECIFIC ERROR WAS NOT NOTATED. NO ADVERSE EFFECT OCCURRED. APPLIED REP WAS NOT PRESENT FOR CASE. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 19JAN2024: THE FACILITY MAY HAVE MEANT THE BLADE LEVER WAS STICKING, BUT I'M NOT SURE. THE ONLY INFORMATION I WAS GIVEN ON THAT DEVICE WAS THAT THE BUTTON WAS STUCK. TYPE OF INTERVENTION: A NEW DEVICE HAD TO BE OPENED. PATIENT STATUS: NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331995 ↗
• MalfunctionOct 9, 2023Failure to Deliver Energy; Failure to Deliver Energy

  PROCEDURE PERFORMED: LAPAROSCOPIC GASTRIC SLEEVE. EVENT DESCRIPTION: REP WAS PRESENT FOR THE CASE. THE DEVICE DID NOT PRODUCE ENERGY ON THE FIRST ACTIVATION. THE GENERATOR MADE NORMAL ACTIVATION AND END TONES. THE SURGEON TRIED AGAIN AND THE SAME THING OCCURRED, NO ENERGY WAS DELIVERED. THE REP UNPLUGGED THE HANDPIECE FROM THE GENERATOR AND PLUGGED IT BACK IN. THE SURGEON TRIED ACTIVATING THREE MORE TIMES AND STILL NO ENERGY WAS DELIVERED, THE GENERATOR MADE THE USUAL ACTIVATION AND END TONES FOR EACH ACTIVATION. THE SURGEON WAS SEALING ON THE GREATER CURVATURE OF THE STOMACH AT THE TIME OF THE EVENT. THERE WERE NO VISIBLE THERMAL EFFECTS AND THE GENERATOR FUNCTIONED NORMALLY. THE SURGEON SWITCHED TO A [COMPETITOR DEVICE] TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 VIA EMAIL FROM PROJECT MANAGER: HE DID NOT TRANSECT AFTER ATTEMPTING TO SEAL SO NO BLEEDING OCCURRED. THANKFULLY THE SURGEON RECOGNIZED THERE WAS NO ENERGY OUTPUT RIGHT AWAY DESPITE THE GENERATOR SEAL CYCLE AND END TONES. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH A [COMPETITOR DEVICE]. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901956 ↗
• MalfunctionMay 10, 2023Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC SIGMOIDECTOMY EVENT DESCRIPTION: LITTLE TO NO ENERGY WAS BEING DELIVERED WHEN THE SURGEON ATTEMPTED TO SEAL THE VESSEL. THE DEVICE MADE THE AUDIBLE NOISES TO INDICATE THAT THE DEVICE WAS WORKING. THE SURGEON WAS GRASPING SMALL INTESTINE TISSUE WHEN THE EVENT HAPPENED. NO ERROR MESSAGES OR ALARMS WERE DISPLAYED ON THE GENERATOR. THE USER WAS ABLE TO NOTE THAT LOW/NO ENERGY WAS BEING DELIVERED WHEN ATTEMPTING TO DISSECT THE TISSUE. NO TISSUE EFFECT WAS OBSERVED. THERMAL EFFECTS WERE NOT VISIBLE AT THE SEAL SITE. IT IS UNKNOWN IF THE SURGEON ACTIVATED THE BLADE AFTER HEARING THE END TONE. BLEEDING WAS NOT OBSERVED AS A RESULT OF THE INCIDENT. THE DEVICE WAS USED FOR ABOUT 3-4 ACTIVATIONS BEFORE THE EXPERIENCE WAS OBSERVED. THIS OCCURRED DURING THE FIRST 10-15 MINUTES AT THE BEGINNING OF THE PROCEDURE. THE SURGEON OPENED UP A NEW HANDPIECE TO COMPLETE THE CASE. NO PATIENT INJURY OCCURRED. PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: THE SURGEON OPENED UP A NEW HANDPIECE TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903163 ↗