Single Use 3-Lumen Sphincterotome V KD-V411M-0330 (REF N5411230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170380563), received between Nov 23, 2021 and Feb 21, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Recalls naming this device

1. Jan 7, 2026Class IIOpen, Classified

   Devices which did not undergo thermoforming could deform and lose performance.

   Z-1271-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WIRE BROKE DURING USE, BUT THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437690 ↗
• MalfunctionMar 12, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SPHINCTEROTOME EXHIBITED THE CUTTING WIRE WAS BROKEN AND THE COATED PORTION OF THE CUTTING WIRE WAS TORN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890903 ↗
• MalfunctionJul 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE 3-LUMEN SPHINCTEROTOME V HAD AN ABNORMAL DIRECTION OF THE KNIFE WIRE. THE REPORTED ISSUE WAS DISCOVERED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. AFTER REPLACING THE LUMEN FOR THE THIRD TIME, THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344664 ↗
• MalfunctionDec 14, 2021Break; Break

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING AN UNKNOWN THERAPEUTIC SPHINCTEROTOMY, THE DOCTOR NOTICED THE PAPILLOTOME WAS STRUGGLING TO CUT UNTIL IT WAS NO LONGER CUTTING. THE DEVICE BLADE WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003983 ↗
• MalfunctionNov 23, 2021Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING THE THERAPEUTIC SPHINCTEROTOMY PROCEDURE, THE PAPILLOTOME DEVICE BEGAN TO CUT, AND THE WIRE BROKE IN THE PROXIMAL PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER PAPILLOTOME OLYMPUS DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862937 ↗