Single Use 3-Lumen Sphincterotome V KD-V411M-0320 (REF N5411130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170380556), received between Jul 13, 2020 and Dec 30, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 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-1268-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931434 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THE SINGLE USE SPHINCTEROTOME'S CUTTING WIRE BROKE. THIS WAS REPORTED TO HAVE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413897 ↗
• MalfunctionOct 15, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE SPHINCTEROTOME THE PROTECTIVE LAYER ON THE CUTTING EDGE DELAMINATED. THE ISSUE OCCURRED THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PROLONGED LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279208 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED WHEN USING THE SUBJECT DEVICE, THE FILAMENT BROKE DURING AN UNSPECIFIED PROCEDURE ON THREE SEPARATE OCCASIONS IN THREE DIFFERENT PATIENTS. IT'S UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORT OF PATIENT HARM. REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125824 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED WHEN USING THE SUBJECT DEVICE, THE FILAMENT BROKE DURING AN UNSPECIFIED PROCEDURE ON THREE SEPARATE OCCASIONS IN THREE DIFFERENT PATIENTS. IT'S UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORT OF PATIENT HARM. REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125614 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED WHEN USING THE SUBJECT DEVICE, THE FILAMENT BROKE DURING AN UNSPECIFIED PROCEDURE ON THREE SEPARATE OCCASIONS IN THREE DIFFERENT PATIENTS. IT'S UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORT OF PATIENT HARM. REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125509 ↗
• MalfunctionOct 4, 2024Break; Break

  IT WAS REPORTED THAT THE SINGLE USE LUMEN SPHINCTEROTOME, THE KNIFE WIRE BROKE (WHEN ELECTRICITY WAS APPLIED), BUT DID NOT FALL OUT. THE EVENT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS THERAPEUTIC. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372112 ↗
• MalfunctionSep 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE 3-LUMEN SPHINCTEROTOME V TIP WIRE WAS BROKEN AT THE FIRST ENERGIZATION. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE CUSTOMER CONFIRMED THAT NO DEBRIS FELL OFF. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE WITH NO DELAY. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17752607 ↗
• MalfunctionOct 26, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), WHEN THE PAPILLOTOME WAS BEING USED TO COMPLETE THE SPHINCTEROTOMY, AND AS SOON AS THE ELECTRO SCALPEL WAS USED, THE BLADE OF THE PAPILLOTOME BROKE. A SECOND PAPILLOTOME (SUBJECT DEVICE), OF THE SAME MODEL AND SAME BATCH, WAS USED AND THE BLADE BROKE AGAIN. THE PROCEDURE WAS COMPLETED USING A PAPILLOTOME FROM ANOTHER COMPANY. THERE WAS A SLIGHT DELAY OF 5-10 MINUTES WHILE CHANGING OUT THE DEVICES. THE BROKEN PIECE DID NOT FALL INSIDE THE PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PRODUCT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO PROBLEMS WERE DETECTED. EVENT 2 OF 2: THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE SECOND PAPILLOTOME DEVICE (SINGLE USE 3-LUMEN SPHINCTEROTOME V), ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) THE ISSUE WITH THE FIRST PAPILLOTOME DEVICE WAS REPORTED UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677971 ↗
• MalfunctionOct 26, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), WHEN THE PAPILLOTOME (SUBJECT DEVICE) WAS BEING USED TO COMPLETE THE SPHINCTEROTOMY, AND AS SOON AS THE ELECTRO SCALPEL WAS USED, THE BLADE OF THE PAPILLOTOME BROKE. A SECOND PAPILLOTOME (SAME MODEL AND SAME BATCH) WAS USED AND THE BLADE BROKE AGAIN. THE PROCEDURE WAS COMPLETED USING A PAPILLOTOME FROM ANOTHER COMPANY. THERE WAS A SLIGHT DELAY OF 5-10 MINUTES WHILE CHANGING OUT THE DEVICES. THE BROKEN PIECE DID NOT FALL INSIDE THE PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PRODUCT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO PROBLEMS WERE DETECTED. EVENT 1 OF 2: THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE FIRST PAPILLOTOME DEVICE (SINGLE USE 3-LUMEN SPHINCTEROTOME V), UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH THE SECOND PAPILLOTOME DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677964 ↗
• MalfunctionMay 10, 2022Break; Break

  THE CUSTOMER REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE BROKE AT THE TIP. THE EVENT OCCURRED DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE OPERATION WAS COMPLETED BY REPLACING THE PRODUCT AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14350361 ↗
• MalfunctionJul 13, 2020Break; Break

  DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST), THE SUBJECT DEVICE WAS USED. WHEN THE USER INSERTED THE SUBJECT DEVICE INTO THE PAPILLA AND TRIED TO CUT THE SPHINCTER, THE CUTTING WIRE BROKE OFF AND FELL. THE FRAGMENT CAME OUT WITH THE SUBJECT DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FALLING OF THE CUTTING WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263552 ↗