Edge E1455-6NSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521037250), received between Oct 17, 2019 and Apr 25, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryApr 25, 2023Melted; Adverse Event Without Identified Device or Use Problem; Melted; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TOTAL HIP REPLACEMENT, IT WAS NOTICED THAT IT WAS MELTING. THERE WAS NO MELTED DEVICE THAT FELL INTO THE PATIENT'S CAVITY NOR STUCK TO THE PATIENT¿S TISSUE. STOPPED THE CASE BRIEFLY TO GET AN X-RAY JUST TO BE SAFE, REMOVED IT, TOOK AN X-RAY TO MAKE SURE NONE OF IT MELTED OFF AND THEN GRABBED A NEW BOVIE TIP.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16811765 ↗
• InjuryApr 22, 2021Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE USING THE EXTENDED TIP CAUTERY ON DEEPER TISSUE, THE PHYSICIAN NOTED THERE WAS A BURN TO THE SUPERFICIAL SKIN ON THE LOWER SIDE OF THE CHEST INCISION. THEY NOTED THE BURN MARK ON THE SKIN AND LOOKED AT THE SHAFT OF THE CAUTERY; THEY NOTICED THERE WAS A BREAK IN THE INSULATION AND IMMEDIATELY REMOVED THE FAULTY CAUTERY TIP FROM THE FIELD. THE BURNT TISSUE WOULD BE SHARPLY DEBRIDED, AND PRIMARY CLOSURE WOULD STILL BE PERFORMED. PATIENT WAS UNDER GENERAL ANESTHESIA AND IT IS UNKNOWN IF PATIENT REQUIRED ADDITIONAL SEDATION DUE TO THIS INCIDENT.

  Patient problems: Burn(s)

  MAUDE report 11706432 ↗
• MalfunctionFeb 5, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LEFT BREAST NIPPLE SPARING MASTECTOMY WITH SENTINEL NODE BIOPSY WITH IMMEDIATE RECONSTRUCTION, THE EXTENDED BOVIE MALFUNCTIONED. THE EXTENDED BOVIE TIP BROKE DOWN AND CAUSED A SUPERFICIAL SKIN BURN ON THE PATIENT'S BREAST.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 11285106 ↗
• MalfunctionOct 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BLADE ELECTRODE CAP WAS FOUND TO BE NOT ATTACHED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9202703 ↗