Neptune E-SEP 0703-310-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327297904), received between Jan 20, 2020 and Apr 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• MalfunctionApr 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE E-SEP LOOP ELECTRODE BROKE. 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 19167362 ↗
• MalfunctionJan 20, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A LLETZ (LARGE LOOP EXCISION OF THE TRANSFORMATION ZONE) PROCEDURE, THE ELECTRODE TIP CAUGHT FIRE. IT WAS ALSO REPORTED THAT THE ELECTRODE TIP WAS USED WITH A COMPETITOR PENCIL. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9607616 ↗