Single Use 3-Lumen Sphincterotome V KD-V411M-0330 (UDI 04953170183997)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170183997), received between Oct 4, 2021 and Sep 28, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  It was reported that the cutting blade broke with the Olympus Single Use Sphincterotome. The issue occurred during a therapeutic Endoscopic Retrograde Cholangiopancreatography procedure. The procedure was completed using a similar device. There was no patient harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914810 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, THE CUTTING WIRE OF THE SUBJECT DEVICE BROKE TWICE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292521 ↗
• InjuryMar 7, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE BROKE WHEN OUTPUTTING. THE ISSUE OCCURRED DURING AN ENDOSCOPIC SPHINCTEROTOMY THERAPEUTIC PROCEDURE. THE PRODUCT WAS REPLACED WITH A NEW ONE OF THE SAME PRODUCT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18860684 ↗
• MalfunctionMar 21, 2023Break; Break

  AS REPORTED, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, KNIFE WIRE BREAKAGE OCCURRED AT THE FIRST ENERGIZATION. THE BROKEN WIRE DID NOT FALL OUT OF THE BODY. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE AND THE INTENDED PROCEDURE WAS COMPLETED WITH NO HARM OR INJURY TO THE PATIENT. NO USER INJURY REPORTED. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588336 ↗
• MalfunctionSep 22, 2022Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THE KNIFE WIRE BROKE ON THE SINGLE USE 3-LUMEN SPHINCTEROTOME V AFTER A FEW USES IN AN ENDOSCOPIC SPHINCTEROTOMY (EST). THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15464664 ↗
• MalfunctionNov 2, 2021Material Separation; Material Separation

  IT IS REPORTED BY THE CUSTOMER, DURING A SPHINCTEROTOMY USING A SINGLE USE 3-LUMEN SPHINCTEROTOME V, THE BLADE BROKE OFF OF THE PROXIMAL END (AND DID NOT FALL INTO THE PATIENT). THIS OCCURRED DURING THE SECOND CUT. THERE WAS A DELAY OF A FEW MINUTES WHILE ANOTHER SPHINCTEROTOME WAS OBTAINED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SECOND SPHINCTEROTOME. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739818 ↗
• MalfunctionOct 4, 2021Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC SPHINCTEROTOMY PROCEDURE, THE BLADE OF THE DEVICE BROKE NEAR THE PROXIMAL PART. THE DEVICE BROKE INSIDE THE PATIENT BUT THE BROKEN PART REMAINED ATTACHED TO THE DEVICE. NO FRAGMENTS CAME OFF AND FELL INTO THE PATIENT. THE BROKEN PART WAS RETRIEVED BY REMOVING THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO HARM OR ADVERSE IMPACT TO THE STATE OF THE PATIENT¿S HEALTH NOR THAT OF ANY OTHER PERSON AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573144 ↗
• MalfunctionOct 4, 2021Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC SPHINCTEROTOMY PROCEDURE, THE BLADE OF THE DEVICE BROKE NEAR THE PROXIMAL PART. THE DEVICE BROKE INSIDE THE PATIENT BUT THE BROKEN PART REMAINED ATTACHED TO THE DEVICE. NO FRAGMENTS CAME OFF AND FELL INTO THE PATIENT. THE BROKEN PART WAS RETRIEVED BY REMOVING THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO HARM OR ADVERSE IMPACT TO THE STATE OF THE PATIENT¿S HEALTH NOR THAT OF ANY OTHER PERSON AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572998 ↗