Edge E2450HNSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884524002231), received between Aug 23, 2019 and Mar 24, 2021 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2021Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CONTINUED TO OPERATE EVEN AFTER THE PUSH BUTTON WAS RELEASED. SURGEON TRIED BOVIE SEVERAL TIMES BEFORE SWITCHING IT OUT. CIRCULATOR ALSO SWITCHED THE BOVIE FROM MONOPOLAR 1 TO MONOPOLAR 2, AND IT CONTINUED TO MALFUNCTION. NO BURN INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 11561012 ↗
• MalfunctionJan 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE OUTPUT OF THE ELECTROSURGICAL KNIFE WAS CHANGED FROM 50W TO 60W, AND AFTER A WHILE, THE TIP OF THE ACCESSORY ELECTRODE GOT CHIPPED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11251033 ↗
• MalfunctionDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BREAST PROCEDURE, THE CAUTERY PENCIL BUTTON BECAME HOT AND EVENTUALLY BURNED THE SURGEON ON THE INDEX FINGER. THE SURGEON TOSSED THE PENCIL FROM THE FIELD.

  Patient problems: Burn(s)

  MAUDE report 10950822 ↗
• MalfunctionJan 9, 2020Fire; Fire

  ACCORDING TO THE REPORTER, THE PENCIL SPARKED AND CAUGHT ON FIRE WHEN USED WITH GENERATOR SETTINGS IN 35 COAGULATION AND 35 CUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9572488 ↗
• MalfunctionDec 9, 2019Unintended Power Up; Unintended Power Up

  ACCORDING TO THE REPORTER, AFTER SURGERY FOR ORTHOPEDIC FRACTURE OF DISTAL END OF FEMUR, THEY FOUND A PART OF CUSHION AND COVER CLOTH PLACED UNDER THE PATIENT'S LEG WAS BURNT. THEY PUT A TRIANGULAR METAL SUPPORTER ON THE BLACK CUSHION AND THE PATIENT PLACED THE RIGHT LEG ON THE SUPPORTER WITH BENDING KNEE TO UPWARD DIRECTION. THEY PLACED COVER CLOTHS ON THE CUSHION AND THEY FOUND ALL THE SAME POSITIONS WERE BURNT. AS PER NURSE'S CONSIDERATION, THE PENCIL WENT BETWEEN THE CUSHION AND THE METAL SUPPORTER AND ACCORDING TO THE REPORT, HAD ACTIVATED ACCIDENTALLY DUE TO THE WEIGHT OF LEG. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437475 ↗
• MalfunctionAug 23, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING THE ARTIFICIAL ANUS CLOSURE PROCEDURE, THE GENERATOR AND PENCIL WERE USED, GAUZE FILLED WITH METHANE GAS ON THE NEAR IGNITED SUDDENLY WHEN USED AROUND THE ARTIFICIAL ANUS. THE IGNITED GAUZE WAS DISCARDED ON THE FLOOR QUICKLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8928073 ↗