Edge E1465-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521713246), received between Nov 6, 2017 and Jan 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Flare or Flash” (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.

• MalfunctionJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TONSILLECTOMY PROCEDURE BY BLUNTLY REMOVING THEM USING COAGULATION FOR THE BLEEDINGS FOR SMALL SPIKED LIKE ACTIVATIONS, THE PATIENT HAD A 4MM SECOND DEGREE BURN ON THE CHEEK PLUS A SMALLER BURN BY THE INSULATED SHAFT PART OF THE INSTRUMENT. THE SURGICAL FIELD WAS DRY AND THEY HAD ALREADY USED IT TO BURN THE OTHER TONSIL PIT AND NOW THEY HAD MOVED TO WORK ON THE OTHER ONE. THEY TREATED THE BURN BY GIVING A COLD AND BURN CREAM.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11208569 ↗
• MalfunctionNov 6, 2017Peeled/Delaminated; Flare or Flash; Peeled/Delaminated; Flare or Flash

  THE CUSTOMER REPORTED THAT DURING A TONSILLECTOMY, THE PATIENT DEVELOPED A TEMPORARY FIRST TO SECOND DEGREE BURN ON THE LIPS. CONSERVATIVE TREATMENT INCLUDED CREAM APPLIED TO THE BURN. EXAMINATION OF THE DEVICE FOUND A HOLE IN THE INSULATION. ANOTHER DEVICE OF THE SAME TYPE WAS USED WITHOUT ISSUE.

  Patient problems: Burn(s)

  MAUDE report 7004490 ↗