Edge E1475XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521713277), received between Dec 14, 2020 and Dec 29, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fire” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2023Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING USE, WHEN USING THE CAUTERY PEN, THE PHYSICIAN ASKED WHY THE DEVICE WAS BENDY AND FOUND THAT THERE WAS A HOLE IN IT. THE NURSE ASKED THE CIRCULATOR FOR NEW CAUTERY. THEY NOTIFIED WITH PHOTO OF DAMAGED PEN AND BURNED END OF TIP. THE CAUTERY BLADE TIP OF THE PENCIL FROM THE OTHER BRAND WAS NORMALLY SWITCHED OUT TO THE MEDTRONIC EDGE HEX-LOCKING BLADE ELECTRODE 2.75¿. THE OTHER BRAND WAS AWARE OF THEIR PRACTICE AND HAVE VALIDATED THAT THE MEDTRONIC TIP WAS COMPATIBLE WITH THEIR PENCIL. WHEN THE OPERATING ROOM NURSES REMOVED THE MEDTRONIC TIP, THEY FOUND IT TO BE CHARRED.

  Patient problems: Insufficient Information

  MAUDE report 18416859 ↗
• MalfunctionDec 14, 2020Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP OF PEN EDGE LOCKING BLADE CAUGHT FIRE WHEREIN IT RESEMBLED A BIRTHDAY CANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11004047 ↗