Edge E1455BNSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521038479), received between Aug 31, 2018 and Aug 31, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2018Peeled/Delaminated; Contamination /Decontamination Problem; Detachment of Device or Device Component; Peeled/Delaminated; Contamination /Decontamination Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE INSULATION OF THE BLADE TIP BROKE IN PIECES AT THE TIME OF MAKING AN INCISION. SOME PIECES FELL INTO THE PATIENT¿S CAVITY, BUT THE PIECES COULD NOT BE LOCATED ON EITHER INSIDE THE PATIENT¿S CAVITY AND OUTSIDE THE CAVITY. IT WAS NOTED THAT THE CAUSED OF THE ISSUE WAS DUE TO DEVICE HAD BEEN ON ELECTRON BEAM STERILIZATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7839127 ↗