Valleylab E2516HNSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524002996), received between Aug 13, 2018 and Jun 12, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2023Self-Activation or Keying; Connection Problem; Adverse Event Without Identified Device or Use Problem; Self-Activation or Keying; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PENCIL WAS PLUGGED INTO THE NON MEDTRONIC GENERATOR, THE PENCIL WAS LAID ON THE PATIENT AND THE STAFF HEARD A BUZZING SOUND. THE DEVICE ACTIVATED WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED. NO ONE WAS NEAR THE PENCIL DURING THIS TIME AND NURSE RAN OVER TO UNPLUG THE CORD. PATIENT HAD A BURN IN THE STOMACH ABOUT 1 INCH IN SIZE. THE BURN WAS CUT OUT AND STITCHED UP. THERE WAS AN ERROR CODE ON THE BOVIE WHEN TRIED TO PLUGGED INTO THE VLFT10GEN GENERATOR-E320. A NEW PENCIL WAS USED. FT10 WAS NOT INVOLVED IN THE BURN INCIDENT.

  Patient problems: Burn(s)

  MAUDE report 17112785 ↗
• MalfunctionAug 13, 2018Fire; Fire

  ACCORDING TO THE REPORTER, THE DEVICE PRODUCED FLAME AND DOCTOR QUIT USING IT. THERE WAS NO PATIENT INVOLVEMENT. A PHOTO SUBMITTED SHOWING THAT THE TIP OF THE PENCIL HAD BURNED.

  Patient problems: No Patient Involvement

  MAUDE report 7778618 ↗