VOYANT® Electrosurgical Generator EA010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915131371), received between Sep 29, 2020 and Sep 29, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 29, 2020No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PROCEDURE PERFORMED: LAVTH. EVENT DESCRIPTION: THE REP WAS NOT PRESENT DURING THE CASE. THE GENERATOR WAS TURNED ON AND WORKED FINE AT SEALING TISSUE DURING THE CASE. HOWEVER, THERE WAS NO AUDIO CUES FROM THE GENERATOR. THE GENERATOR WAS UNPLUGGED AND RE-PLUGGED INTO THE POWER SOURCE AND WAS INSERTED INTO A DIFFERENT POWER SOURCE, BUT IT DID NOT RESOLVE THE AUDIO ISSUE. THE DEVICE KEY WAS REMOVED AND RE-INSERTED INTO THE GENERATOR WITH NO EFFECT ON THE AUDIO ISSUES. NO AUDIO CUES WERE GIVEN FOR EITHER THE EB040 OR THE EB015 THAT WERE USED WITH THE GENERATOR. NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07OCT2020 FROM APPLIED MEDICAL ACCOUNT MANAGER: "BUT THE CASE WAS FINISHED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THEY ONLY HAVE ONE GENERATOR SO HAD A NURSE COME IN THE ROOM AND TELL THE SURGEON EVERY TIME THE SEAL CYCLE COMPLETED." PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10601755 ↗