Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07301A (REF N5393230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170371516), received between Feb 10, 2020 and Sep 8, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (4 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.

• MalfunctionSep 8, 2020Break; Break

  DURING AN ENDOSCOPIC SPHINCTEROTOMY, THREE DEVICES WERE USED. THE CUTTING WIRE OF THE FIRST DEVICE BROKE. THE USER EXCHANGED IT FOR THE SECOND DEVICE AND CONTINUED THE PROCEDURE. THE CUTTING WIRE OF THE SECOND DEVICE BROKE. THE USER EXCHANGED IT FOR THE THIRD DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE CUTTING WIRE OF THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10500652 ↗
• MalfunctionSep 8, 2020Break; Break

  DURING AN ENDOSCOPIC SPHINCTEROTOMY, THREE DEVICES WERE USED. THE CUTTING WIRE OF THE FIRST DEVICE BROKE. THE USER EXCHANGED IT FOR THE SECOND DEVICE AND CONTINUED THE PROCEDURE. THE CUTTING WIRE OF THE SECOND DEVICE BROKE. THE USER EXCHANGED IT FOR THE THIRD DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE CUTTING WIRE OF THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10500645 ↗
• MalfunctionFeb 20, 2020Material Protrusion/Extrusion; Material Split, Cut or Torn; Sharp Edges; Material Protrusion/Extrusion; Material Split, Cut or Torn; Sharp Edges

  THE SERVICE CENTER RECEIVED A REPORT OF FIVE SINGLE USE SPHINCTEROTOME V DEVICES (MODEL KD-VC631Q-07301A), ALL FROM LOT NUMBER 9YV, THAT UPON INSERTION OF THE GUIDEWIRE, IT WENT THROUGH THE SIDE OF THE TOME DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT ALL FIVE DEVICES MALFUNCTIONED IN THE SAME MANNER. THIS IS FOR THE FIFTH KD-VC631Q-07301A DEVICE REPORTED. IT WAS REPORTED THAT THE INTENDED PROCEDURE WAS COMPLETED WITH A NEW DEVICE AND THERE WAS NO PATIENT INJURY. THE DEVICE WAS DISCARDED UPON COMPLETION OF THE PROCEDURE AND WILL NOT BE RETURNED TO THE SERVICE CENTER FOR EVALUATION. THIS IS REPORT 5 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734836 ↗
• MalfunctionFeb 20, 2020Material Protrusion/Extrusion; Material Split, Cut or Torn; Sharp Edges; Material Protrusion/Extrusion; Material Split, Cut or Torn; Sharp Edges

  THE SERVICE CENTER RECEIVED A REPORT OF FIVE SINGLE USE SPHINCTEROTOME V DEVICES (MODEL KD-VC631Q-07301A), ALL FROM LOT NUMBER 9YV, THAT UPON INSERTION OF THE GUIDEWIRE, IT WENT THROUGH THE SIDE OF THE TOME DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT ALL FIVE DEVICES MALFUNCTIONED IN THE SAME MANNER. THIS IS FOR THE THIRD KD-VC631Q-07301A DEVICE REPORTED. IT WAS REPORTED THAT THE INTENDED PROCEDURE WAS COMPLETED WITH A NEW DEVICE AND THERE WAS NO PATIENT INJURY. THE DEVICE WAS DISCARDED UPON COMPLETION OF THE PROCEDURE AND WILL NOT BE RETURNED TO THE SERVICE CENTER FOR EVALUATION. THIS IS REPORT 3 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734807 ↗
• MalfunctionFeb 20, 2020Material Protrusion/Extrusion; Material Split, Cut or Torn; Sharp Edges; Material Protrusion/Extrusion; Material Split, Cut or Torn; Sharp Edges

  THE SERVICE CENTER RECEIVED A REPORT OF FIVE SINGLE USE SPHINCTEROTOME V DEVICES (MODEL KD-VC631Q-07301A), ALL FROM LOT NUMBER 9YV, THAT UPON INSERTION OF THE GUIDEWIRE, IT WENT THROUGH THE SIDE OF THE TOME DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT ALL FIVE DEVICES MALFUNCTIONED IN THE SAME MANNER. THIS IS FOR THE SECOND KD-VC631Q-07301A DEVICE REPORTED. IT WAS REPORTED THAT THE INTENDED PROCEDURE WAS COMPLETED WITH A NEW DEVICE AND THERE WAS NO PATIENT INJURY. THE DEVICE WAS DISCARDED UPON COMPLETION OF THE PROCEDURE AND WILL NOT BE RETURNED TO THE SERVICE CENTER FOR EVALUATION. THIS IS REPORT 2 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734780 ↗
• MalfunctionFeb 10, 2020Material Protrusion/Extrusion; Material Twisted/Bent; Material Split, Cut or Torn; Sharp Edges; Material Protrusion/Extrusion; Material Twisted/Bent; Material Split, Cut or Torn; Sharp Edges

  THE SERVICE CENTER RECEIVED A REPORT OF A SINGLE USE PRELOADED SPHINCTEROTOME V ( MODEL KD-VC631Q-07301A), LOT NUMBER 9YV, THAT CAME APART DURING A PROCEDURE. THE PHYSICIAN WAS PERFORMING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WHEN INSERTING A GUIDEWIRE INTO THE DEVICE IT CAME OUT OF THE SIDE OF THE TOME, LAST 15-20 CM AND THE CANNULA WAS STRIPPED. THIS REPORTED INCIDENT OCCURRED AT THE BEGINNING OF THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH NO DELAY AND WITH A NEW DEVICE. IT WAS REPORTED NO ITEMS FELL INTO THE PATIENT, AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9689123 ↗