VOYANT® Maryland Fusion Device EB015Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607915136956), received between Jun 11, 2019 and Aug 4, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Energy 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: LAPAROSCOPIC LOOP COLOSTOMY / COLOSTOMÍA EN ASA POR LAPAROSCOPIA. EVENT DESCRIPTION: "PRESENTATION WITH DR. [NAME], WHO WAS PERFORMING A LOOP COLOSTOMY USING THE VOYANT MARYLAND REF EB015 LOT 1437974 AND THE VOYANT ELECTROSURGICAL GENERATOR REF EA010 LOT 200000470 WHEN HE REPORTED THAT THE CLAMP WAS INITIALLY INDICATED TO [USER FACILTY] STAFF THAT THE CLAMP NO LONGER OPENED ITS JAWS PLUS THE TISSUE WAS STICKING TOO MUCH, A NEW CLAMP WAS PROVIDED; HOWEVER, AT THE END OF THE PROCEDURE, DR. [NAME] WAS APPROACHED TALKING ABOUT THE INCIDENT, HE INDICATED THAT THE SEALING CYCLE WAS NOT CARRIED OUT PROPERLY, IT ENDED BEFORE AND IN FACT, THE SEALING TONE SOUNDED WITHOUT PRESSING THE BUTTON, WHICH MADE HIM SUSPICIOUS. USE IT, WHICH IS WHY I ORDER A NEW CLAMP, WITH WHICH I COMPLETED THE PROCEDURE WITHOUT ANY PROBLEMS. THE CLAMP WAS COLLECTED AND IS IN SAFEKEEPING FOR SHIPMENT" ADDITIONAL INFORMATION WAS RECEIVED ON 02AU22 VIA EMAIL FROM [NAME]: "THE SURGEON WAS NOT ABLE TO SPECIFY IF TISSUE STICKING LED TO BLEEDING AT ANY POINT OF THE SURGERY, THE SURGEON DID MENTION TISSUE STICKING COULD CAUSE BLEEDING. ALSO, THE SURGEON MENTIONS THE SEAL CYCLE WAS NOT COMPLETING ITSELF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15170285 ↗
• MalfunctionMar 24, 2020Energy Output Problem; Energy Output Problem

  NAME OF PROCEDURE BEING PERFORMED: COLON PROCEDURE TWO COMPLAINTS HAVE BEEN CREATED FROM THIS REPORT. COMPLAINT # (B)(4) (1 OUT OF 2). COMPLAINT # (B)(4) (2 OUT OF 2). LIMITED INFORMATION AVAILABLE AT THIS TIME. THE REP WAS NOT PRESENT DURING THE CASE. THE JAWS OF THE DEVICE WAS PLACED ON THE TISSUE, AND THE FUSE ACTIVATION BUTTON WAS ACTIVATED. THE GENERATOR WENT THROUGH THE FULL SEAL TONES, INCLUDING THE END TONE. THE SURGEON THEN CUT THE TISSUE WITH THE BLADE LEVER. WHEN THE JAWS WERE REMOVED FROM THE TISSUE, IT WAS NOTICED THAT NO ENERGY WAS DELIVERED TO THE TISSUE AND NO SEAL WAS FORMED. THE TISSUE WAS BLEEDING FROM WHERE THE BLADE LEVER TRANSECTED THE TISSUE. THE SURGEON OPENED UP A SECOND DEVICE TO CONTROL THE BLEED BUT IT ALSO DID NOT DELIVER ENERGY TO THE TISSUE. A THIRD DEVICE WAS OPENED WHICH WORKED SUCCESSFULLY. WITH THIS DEVICE THE SURGEON WAS ABLE TO CONTROL THE BLEED AND COMPLETE THE CASE. THE PRODUCTS ARE NOT AVAILABLE FOR RETURN. THEY WERE DISCARDED BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 04MAR2020 FROM [APPLIED MEDICAL REPRESENTATIVE], ENTERED BY [APPLIED MEDICAL REPRESENTATIVE]. "AFTER VISITING THE ACCOUNT TODAY I DISCOVERED THAT THEY DID HO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9873936 ↗
• MalfunctionMar 24, 2020Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: COLON PROCEDURE. TWO COMPLAINTS HAVE BEEN CREATED FROM THIS REPORT. COMPLAINT # (B)(4) (1 OUT OF 2). COMPLAINT # (B)(4) (2 OUT OF 2). LIMITED INFORMATION AVAILABLE AT THIS TIME. THE REP WAS NOT PRESENT DURING THE CASE. THE JAWS OF THE DEVICE WAS PLACED ON THE TISSUE AND THE FUSE ACTIVATION BUTTON WAS ACTIVATED. THE GENERATOR WENT THROUGH THE FULL SEAL TONES, INCLUDING THE END TONE. THE SURGEON THEN CUT THE TISSUE WITH THE BLADE LEVER. WHEN THE JAWS WERE REMOVED FROM THE TISSUE, IT WAS NOTICED THAT NO ENERGY WAS DELIVERED TO THE TISSUE AND NO SEAL WAS FORMED. THE TISSUE WAS BLEEDING FROM WHERE THE BLADE LEVER TRANSECTED THE TISSUE. THIS WAS NOT THE FIRST ACTIVATION OF THIS DEVICE. THE SURGEON OPENED UP A SECOND DEVICE TO CONTROL THE BLEED BUT IT ALSO DID NOT DELIVER ENERGY TO THE TISSUE. A THIRD DEVICE WAS OPENED WHICH WORKED SUCCESSFULLY. WITH THIS DEVICE THE SURGEON WAS ABLE TO CONTROL THE BLEED AND COMPLETE THE CASE. THE PRODUCTS ARE NOT AVAILABLE FOR RETURN. THEY WERE DISCARDED BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 04MAR2020 FROM, APPLIED MEDICAL REPRESENTATIVE. AFTER VISITING THE ACCOUNT TODAY I DISCOVERED THAT THEY DID HOLD THE DEVI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9873842 ↗
• MalfunctionDec 27, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC COLECTOMY. INCIDENT DESCRIPTION: THE DR. TRIED TO SEAL SOME VESSELS AROUND THE PANCREAS. THE PROCEDURE HAD STARTED NOT SO LONG AGO AND THE DEVICE HAD BEEN USED AROUND 20 TIMES. THE JAWS WERE CLEAN. THERE WAS SOME FATTY TISSUE AND THE JAWS GOT STICKED. WHEN HE OPENED THE DEVICE THE TISSUE WOULD TEAR APART CAUSING BLEEDING. BECAUSE OF THE BLEEDING HE HAD TO USE A GRASPER TO CONTROL IT. THEN HE REFUSED TO CONTINUE USING THE DEVICE TO OPEN COMPETITOR'S. HE SUSTAINED THAT OUR DEVICE JAWS WOULD STICK DANGEROUSLY TO THE TISSUE CAUSING THE TISSUE TEARING APART AND TURN INTO BLEEDING. THE PROCEDURE WAS A TRANSVERES COLECTOMY. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 13DEC19 THE SURGEON DID NOT SEAL MULTIPLE TIMES ON THE SAME SEAL SITE WHEN THE TISSUE WAS STICKING. THE PROCEDURE HAD JUST STARTED (AROUND 30 OR 40 MINUTES INCLUDING THE INSUFFLATION AND SO ON). THERE HAD NOT BEEN MANY SEALS YET (AROUND 20) AND FROM ALMOST THE BEGINNING THE TISSUE STARTED TO STICK. AT THIS POINT THEY WERE SEALING FATTY TISSUE SURROUNDING THE PANCREAS AND TRANSVERSE COLON. APPARENTLY NO. ACTUALLY THE SCRUB NURSE TRIED CLEANING THE JAWS WHEN

  Patient problems: Tissue Damage

  MAUDE report 9526286 ↗
• MalfunctionAug 1, 2019Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: SPLENO PANCREATECTOMY LEFT. DURING A VOYANT TEST WITH EB015 DEVICE. THE SURGEON MADE A COAGULATION CYCLE ON A SHORT VESSEL. WHEN HE REMOVED THE DEVICE THE VESSEL WAS BLEEDING. HE REPEATED TWO CYCLES AND THE COAGULATION WAS SUCCESSFUL. DURING THE COAGULATION PROBLEM, THE SURGEON CONVERTED TO LAPAROTOMY FROM LACK OF VISIBILITY. THE PATIENT WAS OBESE. ORIGINAL: PENDANT UN ESSAI VOYANT AVEC UNE PINCE EB015. LE CHIRURGIEN A FAIT UN CYCLE DE COAGULATION SUR UN VAISSEAU COURT. LORSQU'IL A RETIRE LA PINCE LE VAISSEAU SAIGNAIT. IL A REFAIT DEUX CYCLES ET LA COAGULATION A ETE REUSSIE. PENDANT LE PROBLEME DE COAGULATION, LE CHIRURGIEN A CONVERTI EN LAPAROTOMIE DU AU MANQUE DE VISIBILITE. LA PATIENTE ETAIT OBESE. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 22JULY19. NO TENSION WAS APPLIED TO A VESSEL OR BUNDLE THAT WAS BEING SEALED. THE DEVICE WAS BEING USED FOR ABOUT 50 ACTIVATIONS. THERE WAS NO ESCHAR BUILDUP ON THE JAWS WHEN THE INSUFFICIENT HEMOSTASIS WAS OBSERVED. JAWS WERE CLEANED WITH WET COMPRESS ABOUT EVERY 30 ACTIVATIONS. THE SURGEON DID NOT REALLY NOTICE AN IMPROVEMENT WITH HEMOSTASIS IF/WHEN THE JAWS WERE CLEANED. THE INSUFFI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8853498 ↗
• MalfunctionJun 25, 2019Retraction Problem; Retraction Problem

  MR [NAME] SECOND TIME OF USING THE VOYANT MARYLAND BUT FIRST TIME USING FOR THE DAY. PROCEDURE BEING PERFORMED WAS A TLH + BSO. PATIENT IS A 60 YEAR OLD WHO HAS PRE CANCER CONDITION WHICH IS WHY THE PROCEDURE IS BEING PERFORMED. PATIENT HAS DIABETES AND IS TAKING INSULIN BUT NO OTHER MEDICATION THST WOULD AFFECT BLOOD FLOW OR TISSUE COAGULATION. [NAME] ASSISTING MR [NAME] WI5 [NAME] SCRUBBED AND [NAME] AND [NAME] CIRCULATING. A TOTAL OF 96 ACTIVATIONS DURING THE PROCEDURE WITH 4 REACTIVATE ALARM CODES DUE TO SHORT SEAL CYCLES AND A TOTAL OF 6 CLEANS. ON ACTIVATION NUMBER 34 MR [NAME] COMMENTED THAT HE DID NOT THINK THE DEVICE WAS CUTTING AS WELL AS WHEN HE LAST USED IT AND DIDNT FEEL AS SMOOTH. I SUGGESTED THAT THE DEVICE WAS CLEANED AS HE HAD USED IT CONTINUOUSLY FOR 34 ACTIVATIONS AND THE DEVICE HAD NOT YET BEEN CLEANED WITH A SMALL AMOUNT OF ESCHAR BUILD UP. [NAME] CLEANED THE DEVICE AND MR [NAME] CONTINUED TO USE. AFTER THIS THE DEVICE AS CLEANED MORE REGULARLY ON ACTIVATION 49,60,69,78,90 AND 94. ON CLEAN NUMBER 78 [NAME] NOTICED THAT THE BLADE LEVER WAS STICKING WHEN CLEANING, SHE PUSHED THE HANDLE FORWARD TO CFREE THE BLADE AND WIPED THE DEVICE TO GET RID OF ANY ESCHAR BUILD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733108 ↗
• MalfunctionJun 11, 2019Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: "RESECTION" RECTUM CA / RECTUM RESECTION. FIRST TEST WITH EB015 IN NEURUPPIN- WITH OA DR. [NAME], I WAS IN THE OPERATING ROOM AND HAD EXPLAINED THE DEVICES. AFTER APP. 1,5 HOURS OF USE OF EB 015 IN THE PROCEDURE, THE HANDPIECE COULD NOT BE OPENED ANYMORE. TISSUE WAS IN THE DEVICE AND THE DEVICE WAS HANGING ON THE TISSUE. SEVERAL ATTEMPTS TO OPEN THE BRANCHES FAILED, THE SURGEON NEEDED TO CUT THE BRANCHES OUT OF THE DEVICE. IT WAS ONLY FATTY TISSUE - NOT VESSELS AFTERWARDS A SECOND HANDPIECE WAS OPENED - SEE ANOTHER CER NEURUPPIN 2. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE BY EMAIL ON 17MAY2019: THE HANDLE WAS LOCKED ,STICKED - NO BLEEDING. THE SURGEONS DID NOT SEAL SEVERAL TIMES, HE ONLY WANTED TO OPEN THE HANDLE AND BRANCHES. IT WAS LOCKED. THE DEVICE HAD BEEN USED 1,5 HOURS, APP. 60-80 ACTIVATIONS. CLEANING WAS 6¿8 TIMES. THE SURGEON DID NOT NOTICE AN IMPROVEMENT WHEN THE JAWS WERE CLEANED. NO LIQUID OR LUBRICANT SOLUTION WAS APPLIED TO THE JAWS. IT WAS NOT VISIBLE WHERE ALONG THE JAWS THE TISSUE STUCK. THE JAWS WERE NOT SUBMERGED IN FLUID. THE PATIENT DID NOT EXHIBIT ANY VASCULAR PATHOLOGY. THE DEVICE WAS NOT ACTIVATED ON DISEASED OR INFLAME

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689503 ↗