Edge E2350HNSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884524002200), received between Mar 25, 2019 and Apr 1, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE DOING AN INCISION, A MOMENTARY IGNITION OCCURRED. THERE WAS A BURN MARK ON NEARBY GAUZE, BUT AFTER THAT, THE SAME PRODUCT WAS USED WITHOUT ANY PROBLEMS. THERE WERE NO INJURIES TO THE PATIENT OR THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24751262 ↗
• MalfunctionAug 6, 2021Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING INSPECTION, THE DEVICE WAS ACTIVATED WITHOUT PRESSING THE ACTIVATION BUTTON OR SWITCH. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287866 ↗
• MalfunctionMar 25, 2019Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, IT WAS NOTICED THAT THE COATING ON THE TIP OF THE PENCIL HAD PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8449211 ↗