Single Use Preloaded Sphincterotome V KD-V611M-07302SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170403149), received between Aug 28, 2019 and Sep 21, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break; Material Split, Cut or Torn

  It was reported that the the cutting wire of the Sphincterotome reportedly split and subsequently broke during the application of electrical current and its axis to rotated to the left and creating a potential risk of perforation. The issue occurred during a therapeutic Endoscopic Retrograde Cholangiopancreatography procedure. Additional information received there was no perforation. The patient is doing very well and has already been discharged home. There were no reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847297 ↗
• MalfunctionDec 19, 2022Break; Break

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING USE OF THE SINGLE USE PRELOADED SPHINCTERTOME V, WHICH WAS PRELOADED WITH A VISIGLIDE, THE CUTTING WIRE ON THE PAPILLOTOME BROKE. THE PATIENT WAS UNDERGOING A PAPILLOTOMY FOR AN UNKNOWN INDICATION. THE EVENT OCCURRED SPECIFICALLY DURING THE CUTTING PROCESS WHILE ELECTRICITY WAS UTILIZED. THERE WAS A DELAY OF 15 MINUTES WHILE THE PAPILLOTOME WAS EXCHANGED VIA THE WIRE SYSTEM; THE PROCEDURE WAS THEN FINISHED SUCCESSFULLY. ADDITIONAL ANESTHESIA WAS GIVEN BUT NO INJURY OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A SUPPLEMENT WILL BE SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009662 ↗
• MalfunctionFeb 3, 2022Break; Melted; Break; Melted

  THIS DEVICE WAS RETURNED BY THE CUSTOMER FOR THE ISSUE OF THE DEVICE KNIFE WIRE SNAPPING DURING AN UNKNOWN PROCEDURE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, THE CUTTING WIRE WAS FOUND TO BE BROKEN OFF AT THE PROXIMAL END. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE BROKEN OFF KNIFE WIRE OBSERVED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446525 ↗
• MalfunctionAug 28, 2019Break; Break

  DURING A PAPILLOTOMY, THE SUBJECT DEVICE WAS USED. WHEN TENSIONING AND CUTTING THE PAPILLA UNDER NORMAL TENSION IN THE PROCEDURE, THE CUTTING WIRE OF THE SUBJECT DEVICE WAS TORN AT THE COATED PORTION OF THE CUTTING WIRE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON AUGUST 22, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE COATING ON THE CUTTING WIRE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE MISSING OF THE CUTTING WIRE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8938549 ↗