Edge E1465B-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521713260), received between Aug 12, 2020 and Aug 12, 2020 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TONSILLECTOMY, THE INSULATION THAT GUARDS THE NEEDLE TIP CAME OFF OF THE ELECTRODE. THE INSULATION WAS RETRIEVED COMPLETELY AND NO FOREIGN MATERIAL WAS LEFT IN THE PATIENT. THE PHYSICIAN USED A FRESH NEEDLE TIP AND CONTINUED THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395825 ↗