Edge E1450-6NSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521037120), received between Jul 9, 2018 and Apr 6, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fire” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING USE, AFTER THEY RELEASE THE DEVICE'S BUTTON, THE PENCIL CONTINUES TO ACTIVATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620525 ↗
• MalfunctionApr 8, 2020Fire; Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, A TWO INCHES FLAME APPEARED AT THE DEVICE TIP WHEN IT WAS PLUGGED INTO THE GENERATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9937088 ↗
• MalfunctionJul 9, 2018Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE MATERIALS MANAGER ALERTED THEM THAT A PENCIL HAD AN INCIDENT DURING AN OPEN HEART PROCEDURE. THE BOVIE PENCIL CREATED A FIRE INSIDE THE PATIENT¿S ABDOMEN. THEY QUARANTINED THE GENERATOR AS A PRECAUTION. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7670043 ↗