Neptune E-SEP 0703046002Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327379488), received between Apr 6, 2020 and Jul 28, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Unintended Power Up” (4 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, 2024Open, 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-0370-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Fire

  It was reported that, during a procedure at the user facility, the device tip caught fire. It was reported that the issue had no impact on the patient. It was further reported that there were no adverse consequences and no medical intervention as a result of this event. No information was provided regarding whether the procedure was completed successfully or whether the issue caused a surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052912 ↗
• MalfunctionOct 7, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 23233313 ↗
• InjuryFeb 10, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, A BURN TO THE PATIENT WHILE USING E-SEP PENCIL. IT WAS FURTHER REPORTED THAT THE BURN REQUIRED MEDICAL INTERVENTION. NO INFORMATION WAS AVAILABLE REGARDING SURGICAL DELAY OR IF PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Burn(s)

  MAUDE report 21343424 ↗
• MalfunctionJan 2, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055089 ↗
• MalfunctionJul 19, 2024Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE, THE E-SEP PENCIL ACTIVATED WITHOUT THE BUTTONS BEING PUSHED AND THE PATIENT GOT BURNED. THE PENCIL WAS PLUGGED INTO THE GENERATOR AND ACTIVATED WITHOUT EITHER OF THE BUTTONS BEING DEPLOYED. THE PENCIL WAS REMOVED FROM THE FIELD AND A NEW ONE WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE BURN WAS TREATED WITH MARCAINE AND DERMABOND TO PREVENT INFECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THE USER DID NOT USE A HOLSTER WHILE THE PENCIL WAS NOT IN USE.

  Patient problems: Burn(s)

  MAUDE report 19780486 ↗
• MalfunctionMar 20, 2024Fire; Fire

  IT WAS REPORTED THAT DURING AN ANERECTOPLASTY, A FLAME WAS NOTICED COMING FROM THE E-SEP TIP WHEN THE ELECTRODE WAS CHANGED. THEY DIDN'T USE THE STANDARD ELECTRODE THAT CAME IN THE BOVIE. THEY SWITCHED TO THE COLORADO NEEDLE ELECTRODE, A KIRWAN SURGICAL PRODUCT, WHEN THIS NEEDLE WAS PUT IN, IT LOOKED LIKE A LIGHTER EVERY TIME THEY PUSHED COAG. USUALLY THEY USE A PLUG TO ELIMINATE GAS COMING OUT, THEY WERE UNABLE TO DO SO IN THIS SITUATION, EVERY TIME THEY PRESSED COAG, IT FLICKERED LIKE A LIGHTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943320 ↗
• MalfunctionAug 31, 2023Unintended Power Up; Device Remains Activated; Unintended Power Up; Device Remains Activated

  IT WAS REPORTED THAT DURING A PROCEDURE WHEN THE E-SEP PENCIL WAS PLUGGED INTO THE CONSOLE THE "CUT" FUNCTION ACTIVATED. THE PENCIL WAS UNPLUGGED AND RECONNECTED TO THE CONSOLE. THE SAME ISSUE OCCURRED. THE PENCIL WAS REMOVED FROM THE FIELD AND A REPLACEMENT PENCIL WAS USED. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY, MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663133 ↗
• MalfunctionJun 3, 2021Fire; Fire

  IT WAS REPORTED THAT DURING A TOTAL HIP PROCEDURE, THE E-SEP PENCIL CAUGHT FIRE. IT WAS ALSO REPORTED THAT THE SURGEON RECEIVED A BURN ON THE RIGHT FORE-FINGER THAT DID NOT REQUIRE ANY MEDICAL INTERVENTION.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 11931200 ↗
• MalfunctionApr 6, 2020Particulates; Particulates

  IT WAS REPORTED THAT PRIOR TO THE SURGICAL PROCEDURE, A HAIR WAS FOUND IN THE PACKAGE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9929732 ↗