Neptune E-SEP 0703047002Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 07613327379471), received between Aug 5, 2022 and Aug 11, 2026 — classified as 1 injury, 97 malfunctions.

The most frequently reported specific device problem is “Unintended Power Up” (94 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 4, 2024Class IIOpen, Classified

   There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

   Z-0366-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during use in a procedure at the user facility, a patient sustained a burn while using a Smoke Evac Pencil. It was further reported that the noted wound required medical intervention. The wound was closed by the surgeon. It was further reported that the procedure was completed successfully, without delay.

  Patient problems: Burn(s)

  MAUDE report 50201872 ↗
• MalfunctionDec 21, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE E-SEP PENCIL WAS CONNECTED TO THE CONSOLE, IT MADE A "BEEPING" NOISE. WHEN THE SURGEON TOUCHED THE PENCIL, SHE WAS BURNED. THE ITEM WAS REPLACED BY ANOTHER CAUTERY DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY.

  Patient problems: Burn(s)

  MAUDE report 18380174 ↗
• MalfunctionOct 19, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17963544 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953411 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953382 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953348 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953265 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953261 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953227 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952988 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952947 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952890 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952870 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952822 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952771 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952746 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952741 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952666 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952618 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952428 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952229 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952206 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952191 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952133 ↗
• MalfunctionOct 17, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, UPON BEING PLUGGED IN THE E-SEP PENCIL WOULD MAKE A BUZZING SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951906 ↗