Edge E1455BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521713208), received between Oct 10, 2021 and Jul 12, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LEFT AXILLARY LYMPH NODE DISSECTION, DURING DISSECTION OF TISSUE WITHIN SURGICAL SITE, THE ELECTRODE WITH THE SAFETY SLEEVE WAS PULLED FOR A CASE. THE SCRUB TECH WHEN REALIZING IT WAS NOT COMPATIBLE WITH THE CVPLP2000, ATTEMPTED TO CUT THE SAFETY SLEEVE OFF, AND THEN FORCED THE ELECTRODE ONTO THE BOVIE PENCIL WITH A PAIR OF GRASPERS OR SIMILAR DEVICE AND THAT TORE THE INSULATED LINING ON THE BOVIE PENCIL, CAUSING AN ALTERNATE PATHWAY FOR THE ELECTRICITY WHICH CAUSED THE PATIENT SMALL 1 CM BURN INSIDE THE SURGICAL DISSECTION SITE UP TO THE EDGE OF THE INCISION. ITEMS LISTED WERE REPLACED AND ITEMS INVOLVED WERE SEQUESTERED IN ORDER TO COMPLETE THE CASE. THE BURN HAS BEEN BANDAGED, AND THE PATIENT IS DOING WELL WITH NO CONCERNS.

  Patient problems: Burn(s)

  MAUDE report 19735795 ↗
• MalfunctionOct 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ADIPOSE TISSUE REDUCTION OF ABDOMINAL WALL BY LIPECTOMY, THE EDGE COMPONENT OF ELECTROSURGICAL TIP MELTED AND THE DISTAL END ENDED UP WITH MELTED DEBRIS. IT HAD CONTACT WITH THE PATIENT BUT DID NOT CAUSE HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602665 ↗