Single Use 3-Lumen Sphincterotome V KD-V411M-3030 (UDI 04953170184154)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170184154), received between Aug 25, 2022 and Jan 29, 2024 — classified as 3 malfunctions.

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

Recalls naming this device

1. Jan 7, 2026Class IIOpen, Classified

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

   Z-1292-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE KNIFE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS TURNED IN THE OPPOSITE DIRECTION. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE COATING WAS TORN. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18593965 ↗
• MalfunctionMay 18, 2023Break; Melted; Material Split, Cut or Torn; Break; Melted; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS THAT AFTER THE ENDOSCOPIC SPHINCTEROTOMY PROCEDURE BEGAN A SPARK OCCURRED AND THE SINGLE USE 3-LUMEN SPHINCTEROTOME V BROKE. THE PROCEDURE WAS COMPLETED AFTER THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954055 ↗
• MalfunctionAug 25, 2022Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC SPHINCTEROTOMY THE KNIFE WIRE BROKE WHILE IT WAS ACTIVATED BUT NO DEVICE FRAGMENT FALL. THE PROCEDURE WAS COMPLETED USING A DIFFERENT BUT SIMILAR DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298465 ↗