VOYANT® Electrosurgical Generator EA020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915137601), received between Oct 26, 2021 and Jan 27, 2026 — classified as 3 injuries, 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Electrical /Electronic Property Problem; Sparking; Electrical Shorting

  PROCEDURE PERFORMED: N/A (BEFORE THE PROCEDURE). EVENT DESCRIPTION: "THE DEVICE WAS BROUGHT INTO THE ROOM BEFORE SURGERY. THE EVENT OCCURRED WHEN IT WAS PLUGGED IN FOR A FUNCTIONALITY CHECK. WHEN THE DEVICE¿S POWER CABLE IS PLUGGED INTO THE SOCKET, IT IMMEDIATELY CAUSES A SHORT CIRCUIT AND TRIPS THE CIRCUIT BREAKER. THE ISSUE PERSISTS EVEN AFTER TESTING WITH DIFFERENT POWER CABLES AND SOCKETS, INDICATING THAT THE PROBLEM IS LIKELY INTERNAL TO THE DEVICE." INTERVENTION: A NEW DEVICE HAS BEEN INSTALLED AT THE HOSPITAL. PATIENT STATUS: N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191543 ↗
• InjurySep 11, 2023Optical Obstruction; Optical Obstruction

  PROCEDURE PERFORMED: LAP APPENDECTOMY EVENT DESCRIPTION: INFORMATION IN INITIAL EMAIL: WE HAD A REPORT FROM TH3 WHEN USING THE [COMPETITOR TROCAR] LAPAROSCOPIC SYSTEM WITH THE VOYANT, IT WAS CAUSING THE CAMERA SCREEN TO FLICKER ON AND OFF, CAN YOU ADVISE HAVE YE ENCOUNTERED THE VOYANT TO INTERFERE WITH SURROUNDING EQUIPMENT PREVIOUSLY COMPLAINT FORM INFORMATION: LAP APPENDECTOMY BEING PERFORMED IN EMERGENCY THEATRE WHEN CAMERA STACK WENT BLANK WHILE ACTIVATING THE 5MM FUSION (EB210) DEVICE. CASE SOPPED AND CAMERA AND ACCESSORIES SET UP AGAIN. SAME REACTION TO NEXT ACTIVATION. WHEN THE CAMERA SYSTEM WAS REBOOTED THE SURGEON [NAME REDACTED] DISCOVERED THE TIP OF THE LAP VOYANT INSTRUMENT HAD TOUCHED THE ADJOINING STRUCTURE CECUM AND CAUSED A PATIENT BURN. THE REPAIR WAS DONE LAPAROSCOPICALLY WITH LAP STAPLERS. EMERGENCY THEATRE SET UP. MOST ELECTRO SURGICAL EQUIPMENT IN USE WERE IN CLOSE PROXIMITY. PATIENT WAS REQUIRED TO HAVE CECUM REPAIRED POST INJURY WITH LAPAROSCOPIC STAPLERS. DEVICE WAS REMOVED FROM THE PROCEDURE. GENERATOR USED: (B)(6) SERIAL NUMBER (B)(6). INFORMATION RECEIVED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 23MAY23: I HAVE CHECKED WITH THE HOSPITAL BIOMED WHO R

  Patient problems: Burn(s)

  MAUDE report 17725837 ↗
• InjuryFeb 8, 2022Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: SLEEVE GASTRECTOMY. EVENT DESCRIPTION" POST-OP OOZING OR BLEEDING INCIDENTS, THE END-USER CLAIMED TO BE CAUSED BY THE VESSEL SEALING DEVICE, GENERATOR WAS REMOVED AS A PRECAUTION MEASURE FOR FURTHER INVESTIGATION. ADDITIONAL INFORMATION RECEIVED ON JANUARY 18, 2022: WAS THERE ANY BLEEDING DURING THE SURGERY? NO INTRA-OPERATIVE BLEEDING. IS THERE ANY REASON WHY THE DOCTOR ASSOCIATED THE EVENT TO BE RELATED TO THE VOYANT GENERATOR AS IT ONLY DELIVERS ENERGY? THE OR STAFF DIDN¿T KEEP THE HANDPIECES THAT WERE USED IN THE SURGERIES, THEREFORE, WE TOOK OUT THE GENERATOR AS A PRECAUTION MEASURE FOR FURTHER INVESTIGATION. MIGHT THE EXPERIENCE BE RELATED TO THE VOYANT HANDPIECE THAT WAS USED WITH IT INSTEAD? WE CAN¿T KNOW, THE HAND PIECES USED IN BOTH CASES WERE THROWN AWAY, THEREFORE WE NEED TO CHECK IN CASE OF ANY DYSFUNCTION IN THE GENERATOR ITSELF. IS THERE ANY FURTHER BACKGROUND AS TO WHAT OCCURRED DURING THE SURGERY? AS INFORMED THEY HAD NO ISSUES DURING THE SURGERY, PATIENTS WERE DELIVERED TO ER A WEEK LATER WITH POST-OP BLEEDING. ADDITIONAL INFORMATION ON JANUARY 31, 2022: YES, TWO PATIENTS WERE OPERATED IN THE SAME DAY, SUFFERED FROM SEVERE INTRA ABDOMINAL BLEE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13486686 ↗
• InjuryFeb 8, 2022Energy Output Problem; Energy Output Problem

  PROCEDURE PERFORMED: SLEEVE GASTRECTOMY. EVENT DESCRIPTION" POST-OP OOZING OR BLEEDING INCIDENTS, THE END-USER CLAIMED TO BE CAUSED BY THE VESSEL SEALING DEVICE, GENERATOR WAS REMOVED AS A PRECAUTION MEASURE FOR FURTHER INVESTIGATION. ADDITIONAL INFORMATION RECEIVED ON JANUARY 18, 2022: WAS THERE ANY BLEEDING DURING THE SURGERY? NO INTRA-OPERATIVE BLEEDING. IS THERE ANY REASON WHY THE DOCTOR ASSOCIATED THE EVENT TO BE RELATED TO THE VOYANT GENERATOR AS IT ONLY DELIVERS ENERGY? THE OR STAFF DIDN¿T KEEP THE HANDPIECES THAT WERE USED IN THE SURGERIES, THEREFORE, WE TOOK OUT THE GENERATOR AS A PRECAUTION MEASURE FOR FURTHER INVESTIGATION. MIGHT THE EXPERIENCE BE RELATED TO THE VOYANT HANDPIECE THAT WAS USED WITH IT INSTEAD? WE CAN¿T KNOW, THE HAND PIECES USED IN BOTH CASES WERE THROWN AWAY, THEREFORE WE NEED TO CHECK IN CASE OF ANY DYSFUNCTION IN THE GENERATOR ITSELF. IS THERE ANY FURTHER BACKGROUND AS TO WHAT OCCURRED DURING THE SURGERY? AS INFORMED THEY HAD NO ISSUES DURING THE SURGERY, PATIENTS WERE DELIVERED TO ER A WEEK LATER WITH POST-OP BLEEDING. ADDITIONAL INFORMATION ON JANUARY 31, 2022: YES, TWO PATIENTS WERE OPERATED IN THE SAME DAY, SUFFERED FROM SEVERE INTRA ABDOMIANAL BLE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13486210 ↗
• MalfunctionOct 26, 2021Energy Output Problem; Temperature Problem; Energy Output Problem; Temperature Problem

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: WE HAD OUR NEW GENERATOR IN THE HOSPITAL AFTER REPLACING THE OLD VERSION IN DIFFERENT DEPARTMENTS. WE NOTICED COMPLAINS MAINLY FROM THE OB/GYN DEPARTMENT THAT THE OPEN VOYANT EB240 HEATS UP A LOT AND CAUSING HARMFUL THERMAL SPREAD. AFTER ATTENDING A CASE WITH THE SURGEON AND SEEING THE UNUSUAL THERMAL SPREAD WE DECIDED TO CHANGE THE GENERATOR. WE TRIED A DIFFERENT GENERATOR AND THE PROBLEM WAS SOLVED. KINDLY NOTE THAT THE GENERATOR DIDN'T GIVE ANY ALARM OR AN ERROR WAS DISPLAYED. ADDITIONAL INFORMATION PROVIDED BY APPLIED LEBANON VIA EMAIL 06OCT21: NO PATIENT INJURY. 4-5 HANDPIECES THAT WERE USED WITH THE GENERATOR. THE GENERATOR WASN'T GIVING AN ERROR, THERE WAS AN UNUSUAL THERMAL SPREAD THAT THE SURGEON NOTICED AND CALLED US IN. NO ERROR CODE DISPLAYED, AFTER WE REALIZED THE THERMAL SPREAD THAT WAS OCCURRING ONLY IN THE OB/GYN SERVICE WE DECIDED TO TRY USING A DIFFERENT GENERATOR. AFTER REPLACING THE GENERATOR THE THERMAL SPREAD DECREASED. NO HANDPIECES TO RETURN. TYPE OF INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701285 ↗