Neptune E-SEP 0703047001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327117219), received between Mar 25, 2025 and Mar 26, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (2 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-0367-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionMar 26, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE COAGULATION FUNCTION DID NOT WORK WELL. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699656 ↗
• MalfunctionMar 25, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, WHILE USING SMOKE EVAC PENCIL, COAGULATION FUNCTION DID NOT WORK WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690680 ↗