Voyant Open Fusion Device EB040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915137953), received between Jun 13, 2018 and Feb 19, 2020 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionFeb 19, 2020Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: RIGHT HEMICOLECTOMY. INCIDENT DESCRIPTION: DOC. [NAME] (HEAD OF GENERAL AND BARIATRIC SURGERY) DID THE PROCEDURE OF RIGHT HEMICOLECTOMY. HE KNOWS VOYANT VERY WELL. DOCTOR USED VOYANT OPEN FUSION AND DURING THE PROCEDURE WHEN HE CLOSED THE JAWS, HE COULDN'T OPEN IT ANY MORE. EVEN AFTER PROCEDURE AND AFTER THEY WASHED DEVICE, THEY COULDN'T OPEN THE JAW. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR VIA EMAIL ON 29JAN2020: THE DEVICE JAMMED WITHOUT TISSUE BETWEEN THE JAWS. THE SITUATION WAS RESOLVED BY USING ANOTHER DEVICE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729654 ↗
• InjuryJan 14, 2019Output Problem; Output Problem

  PROCEDURE PERFORMED: LAP ASSISTED VAGINAL HYSTERECTOMY. "NURSE REPORTED THE INCIDENT. NURSE JUST SAID THE SURGEON WAS SEALING THE UTERINE VESSELS AND THOUGHT THE VESSELS WERE SEALED AND MACHINE SHOWED THAT IT WAS FUNCTIONING RIGHT, BUT THEN THE SURGEON SAW THE PELVIS WAS FULL OF BLOOD." ADDITIONAL INFORMATION WAS RECEIVED VIA TELEPHONE ON (B)(6) 2018 AT 8:18AM FROM NURSE THE CASE WAS A VAGINAL HYSTERECTOMY. THE SURGEON SEALED THE UTERINE VESSELS ON EACH SIDE AND DID NOT HEAR ANY ALARMS. THE SURGEON WENT DOWN BELOW TO CONTINUE THE CASE AND WHEN THE SURGEON LOOKED AT TOP, THE PELVIS WAS FULL OF BLOOD. THE VESSELS DID NOT SEAL. THE NURSE DID NOT KNOW IF THE SURGEON HEARD AN END TONE AFTER EACH SEAL. THE SURGEON STATED THAT THERE WERE NO ALARMS AND NOTHING OUT OF THE ORDINARY. THE SURGEON HAS USED THE VOYANT DEVICES MULTIPLE TIMES. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF BLOOD. THE PATIENT'S CURRENT STATUS IS UNKNOWN. THE NURSE WAS NOT IN THE ROOM THE ENTIRE TIME. IT IS UNKNOWN HOW MANY ACTIVATIONS OR HOW LONG THE SURGEON USED THE DEVICE PRIOR TO NOTICING THE BLEEDING. PATIENT VASCULAR PATHOLOGY OR ANY CO-MORBIDITIES ARE UNKNOWN. BOTH OF THE DEVICES ARE AVAILABLE FOR RETURN. "THE CA

  Patient problems: Blood Loss; Injury

  MAUDE report 8246419 ↗
• InjuryOct 29, 2018Output Problem; Output Problem

  PROCEDURE PERFORMED: TOTAL ABDOMINAL HYSTERECTOMY. INCIDENT DESCRIPTION: THIS WAS HIS 4TH TIME USING THE VOYANT HANDPIECE. THERE WERE NO ALARMS OR MISFIRES. SURGEON RATED THE DEVICE AS CLINICALLY SUPERIOR ON THE EVALUATION. PATIENT WAS IN RECOVERY AFTER THE SURGERY WHEN IT WAS NOTICED THAT SHE HAD LOW BLOOD PRESSURE, 70 OVER 40 AND A PALE COMPLEXION. PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND FOUND BLOOD LOSS OF 1200CC DUE TO A HEMATOMA IN THE ADNEXAL PEDICLES. PATIENT GIVEN BLOOD TRANSFUSION AND WAS FINE. REP VERIFIED THAT THE PATIENT HAD NOT BEEN ON STEROIDS OR BLOOD THINNERS. PATIENT STATUS: PATIENT FINE, GIVEN BLOOD TRANSFUSION. RECOVERED WELL.

  Patient problems: Blood Loss

  MAUDE report 8017443 ↗
• MalfunctionJun 13, 2018Output Problem; Output Problem

  PROCEDURE PERFORMED: EXTENDED RIGHT HEMICOLECTOMY. INCIDENT DESCRIPTION: DURING THE CASE THE VOYANT OPEN FUSION WAS USED TO CUT AND SEAL VESSELS AS REQUIRED. THEY NOTICED TWO PARTICULARLY SIGNIFICANT BLEEDS THAT THE VOYANT SYSTEM FAILED TO SEAL AND STOP THE BLOOD FLOW. MIDWAY THROUGH THE CASE THE SURGEON STOPPED USING THE DEVICE. TECH REQUESTED THE DEVICE BE KEPT FOR RETURN TO APPLIED MEDICAL BUT UNFORTUNATELY IT WAS DISPOSED OF IN ERROR. WE DO NOT HAVE THE DEVICE USED TO RETURN, BUT THE REMAINING DEVICE FROM THAT BATCH (UNUSED) IS AVAILABLE IF REQUIRED? I ATTENDED THEATRE TODAY ((B)(6) 2018) AND ARRANGED TO RETURN ON THE (B)(6) 2018 TO DISCUSS IN MORE DETAIL WHAT HAPPENED WITH THE SURGEON. REPLACEMENT DEVICE NOT REQUIRED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL TEAM MEMBER, 25 MAY 2018: HE HAS USED VOYANT ON SEVERAL OCCASIONS BEFORE WITHOUT INCIDENT. LAST THURSDAY (B)(6), HE WAS USING EB040 OPEN FUSION DURING AN EXTENDED RIGHT HEMICOLECTOMY. VOYANT WAS WORKING AS IT SHOULD WHILST DISSECTING AND MOBILISING TISSUE. HE ATTEMPTED TO CUT AND SEAL THE RIGHT COLIC ARTERY , WHICH IS NOT BIG, BUT ALTHOUGH SOME TISSUE CHARRED, IT (VOYANT) DID NOT SEAL THE VESSEL AT ALL. IT WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7599407 ↗