Neptune E-SEP 0703-315-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327297959), received between Sep 27, 2022 and Jun 10, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE E-SEP SAFEAIR ELECTRODE TIP BROKE HALF WAY THROUGH. 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 19498781 ↗
• MalfunctionJan 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP), THE BLADE BROKE AT THE TIP. 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 16258774 ↗
• MalfunctionOct 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DIATHERMY T-LOOP WIRE BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15662963 ↗
• MalfunctionOct 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DIATHERMY T-LOOP WIRE BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15662697 ↗
• MalfunctionOct 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DIATHERMY T-LOOP WIRE BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15662609 ↗
• MalfunctionSep 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER A MEDICAL PROCEDURE, IT WAS NOTED THAT THE DIATHERMY T-LOOP WIRE WAS BROKEN. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493527 ↗