Edge E1450GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521713147), received between Dec 4, 2020 and Apr 3, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fire” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UNIT DIATHERMY TIP SET ON FIRE LIKE A MATCH WHILST BEING USED ON A PATIENT. THE FLAME WAS QUICKLY PUT OUT AND THERE WAS NO OPERATING ROOM FIRE NOTED. A NEW TIP WAS PUT IN THE PENCIL AND WORKED FINE FOR THE REST OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667819 ↗
• MalfunctionNov 24, 2021Fire; Fire

  ACCORDING OT THE REPORTER, AFTER INCISION DURING A BELOW-KNEE AMPUTATION, THE DEVICE WAS REMOVED FROM THE OPERATIVE SITE AND A FLAME WAS NOTED ON THE TEFLON TIP OF THE DEVICE. THE FLAME WAS IMMEDIATELY EXTINGUISHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868680 ↗
• MalfunctionOct 31, 2021Fire; Fire

  ACCORDING TO THE REPORTER, DURING BELOW-KNEE AMPUTATION, AFTER INCISION, THE BOVIE HAND PIECE WAS REMOVED FROM THE OPERATIVE SITE AND A FLAME WAS NOTED ON THE TEFLON COATED TIP OF THE BOVIE. THE FLAME WAS IMMEDIATELY EXTINGUISHED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725721 ↗
• MalfunctionDec 30, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE KNIFE WAS SUPPOSED TO BE NON-ADHESIVE BUT IT WAS NOT, WHICH INCREASED THE SURGICAL TIME. THERE WAS NO PATIENT INJURY, AND THERE WAS NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094098 ↗
• MalfunctionDec 28, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE KNIFE WAS SUPPOSED TO BE NON-ADHESIVE BUT IT WAS NOT, WHICH INCREASED THE SURGICAL TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077074 ↗
• MalfunctionDec 4, 2020Fire; Fire

  ACCORDING TO THE REPORTER, DURING A MASTECTOMY, THE ELECTRODE CAUGHT FIRE. ACCORDING TO MEDICAL STAFF, IT BURNED LIKE A SMALL TORCH. THEY CHANGED TO ANOTHER ELECTRODE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944146 ↗