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VOYANT® Maryland Fusion Device EB017Recalls & reported problems

Applied Medical Resources Corporation · Electrosurgical Sealer and Divider handpiece · Class 2

All models of VOYANT Maryland Fusion Device (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915138547), received between Mar 15, 2023 and Mar 15, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

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

Device problems

  • Mechanical Jam1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 15, 2023Mechanical Jam; Mechanical Jam

    PROCEDURE PERFORMED: LEFT HEMICOLECTOMY. EVENT DESCRIPTION: LEFT HEMICOLECTOMY. DURING THE OPERATION KNIFE IN THE VOYANT MARYLAND OPEN FUSION HAS BLOCKED ON THE TISSUE. HE COULDN'T OPEN THE JAWS. HE HAS TO RESECT SOME TISSUE TO TAKE THE DEVICE OUT. PATIENT WAS HP POSITIVE SO THEY HAD TO DISPOSE THE DEVICE. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR VIA EMAIL 24MAR23: PATIENT IS FINE. THERE WERE NO POST OPERATIVE COMPLICATIONS. AFTER THEY HAD TO RESECT THE TISSUE TO TAKE THE DEVICE OUT, SURGEON COMPLETED THE PROCEDURE WITHOUT ANY ADVANCED ELECTRIC DEVICE. THE HANDLE WAS GETTING STUCK IN THE LATCHED POSITION PREVENTING THE JAWS FROM OPENING. SURGEON COULDN'T MOVE HANDLE. IT WAS BLOCKED. SURGEON HAD TO CUT TISSUE TRAPPED IN JAWS. THERE WAS A LITTLE BLEEDING. THIS WAS OBSERVED ONCE. THE DEVICE HAD BEEN USED FOR ABOUT 20-30 ACTIVATIONS BEFORE THE EXPERIENCE WAS OBSERVED. SURGEON DOESN'T REMEMBER WHAT TISSUE TYPE AND THICKNESS/SIZE WAS BEING CUT WHEN THE STUCK BLADE WAS NOTICED. THE JAWS WERE CLEANED DURING THE PROCEDURE MANY TIMES BY MOIST GAUZE. THEY COULDN'T CLEAN JAWS AFTER THAT, BECAUSE THEY WERE BLOCKED. INTERVENTION: HE HAS TO RESECT SOME TISSUE TO TAKE THE DEVICE OUT. PATIE

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 16546234 ↗

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Sources and updates

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