Neptune E-SEP 0703-320-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327297898), received between Aug 31, 2018 and Nov 16, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE T-LOOP ELECTRODE BURNT OUT.

  Patient problems: Insufficient Information

  MAUDE report 18152992 ↗
• MalfunctionNov 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE T-LOOP ELECTRODE BURNT OUT.

  Patient problems: Insufficient Information

  MAUDE report 18152862 ↗
• MalfunctionNov 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE T-LOOP ELECTRODE BURNT OUT. THIS IS EVENT #1 OF 3.

  Patient problems: Insufficient Information

  MAUDE report 18152668 ↗
• MalfunctionNov 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE END OF T-LOOP ELECTRODE BURNT OUT. 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 18141800 ↗
• MalfunctionSep 21, 2023Fracture; Fracture

  PER MEDWATCH REPORT (B)(4): IT WAS REPORTED THAT DURING A PROCEDURE THE ELECTRODE BROKE WHILE IN USE. NO PIECES WERE BROKEN OFF IN THE PATIENT AND ANOTHER ELECTRODE WAS USED TO FINISH THE PROCEDURE. ANOTHER ELECTRODE HAD TO BE OBTAINED WHICH ONLY TOOK A COUPLE OF MINUTES. 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 17787811 ↗
• MalfunctionMar 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP BROKE. 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 16609406 ↗
• MalfunctionFeb 3, 2023Melted; Overheating of Device; Melted; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE E-SEP PENCIL TIP MELTED. 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 16294586 ↗
• 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 16258731 ↗
• MalfunctionOct 31, 2022Fracture; Fracture

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

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15704388 ↗
• MalfunctionOct 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE T-LOOP BROKE. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15704327 ↗
• MalfunctionSep 12, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING A LARGE LOOP EXCISION OF THE TRANSFORMATION ZONE(LLETZ) SURGICAL PROCEDURE, THE LOOP ELECTRODE BROKE WHILE CUTTING. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7870450 ↗
• MalfunctionAug 31, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING A LARGE LOOP EXCISION OF THE TRANSFORMATION ZONE (LLETZ) SURGICAL PROCEDURE, THE LOOP ELECTRODE BROKE WHILE CUTTING. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7838514 ↗