Edge E1450XNSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521175426), received between Mar 24, 2021 and Oct 27, 2023 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A BELOW THE KNEE AMPUTATION, THE TEAM WAS USING THE CAUTERY TO OBTAIN HEMOSTASIS AS PER USUAL. THERE WAS A NON-MEDTRONIC GAUZE SPONGE AT THE WOUND BUT NOT WHERE THEY WERE CAUTERIZING (MAYBE 3CM AWAY) AND THEY NOTICED THAT IT TURNED COLOR AND THEN A SMALL FLAME APPEARED. THE SPONGE WAS IMMEDIATELY REMOVED FROM THE FIELD. THERE WAS NO OBVIOUS FLAMMABLE SUBSTANCE ON THE FIELD, THE PREP WAS DONE AT THE BEGINNING OF THE CASE, AND THE PATIENT WAS INTUBATED, SO THERE WAS NO OXYGEN SOURCE ON THE FIELD. THERE WAS NO FIRE ON THE FIELD, WOUND, AND DRAPES AND THERE WAS NO SOOT OR CHAR. THE BOVIE PEN, GROUNDING PAD, AND MACHINE WERE ALL REMOVED FROM THE CASE. THE SPONGE WAS SECURED AS WELL. THEY WERE ABLE TO COMPLETE THE PROCEDURE SAFELY. THERE WAS NO PATIENT/STAFF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023420 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TONSILLECTOMY PROCEDURE, IT DID NOT GO ALL THE WAY DOWN INTO THE PENCIL AND A PATIENT WAS BURNED ON THE LIP BECAUSE OF THE EXPOSED METAL AT THE BASE. FOLLOW UP CARE WAS PROVIDED TO THE PATIENT AND PATIENT WAS READMITTED TO THE HOSPITAL ON TWO OCCASIONS AFTER THE PROCEDURE. PATIENT CURRENTLY DOING FINE.

  Patient problems: Burn(s)

  MAUDE report 17295295 ↗
• MalfunctionApr 12, 2021Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, THE DEVICE TIP WAS DAMAGED. A PHOTO WAS ATTACHED SHOWING THE DEVICE INSULATION WAS DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 11654210 ↗
• MalfunctionMar 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE TEFLON BOVIE WAS COMING OFF.

  Patient problems: Insufficient Information

  MAUDE report 11562248 ↗