Single Use 3-Lumen Sphincterotome V KD-V411M-0720 (REF N5411330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04953170380570), received between Nov 9, 2018 and Nov 19, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (18 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-1272-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME WIRE IS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596028 ↗
• MalfunctionMar 27, 2025Break; Sparking; Break; Sparking

  IT WAS REPORTED; THE SUBJECT DEVICE HAD THREE DIFFERENT SPHINCTEROTOMES "BURST". THE ISSUE WAS FOUND DURING SET UP AND INSPECTION FOR USE. NO PATIENT HARM WAS REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707593 ↗
• MalfunctionMar 25, 2025Burst Container or Vessel; Burst Container or Vessel

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691830 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT THE SPHINCTEROTOME BURST. THE EVENT OCCURRED DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21680125 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT THE DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE SUBJECT DEVICE'S KNIFE WIRE BROKE WHEN THE CURRENT WAS APPLIED CONTINUOUSLY. REPORTEDLY, THE CURRENT WAS APPLIED BUT IT WAS DIFFICULT TO CUT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT ANY DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855486 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT THE KNIFE BROKE WHEN POWER WAS APPLIED. THE EVENT OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855191 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THE KNIFE WIRE OF THE SPHINCTEROTOME BROKE. THE ISSUE OCCURRED DURING A LITHOTRIPSY PROCEDURE. 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 20125779 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT THE SINGLE-USE 3-LUMEN SPHINCTEROTOME V WAS BROKEN. THE ISSUE OCCURRED DURING PRE-USE FOR A BILIARY ENDOSCOPIC SPHINCTEROTOMY. WHEN PERFORMING AN INSERTION TEST INTO THE DUODENOSCOPE FORCEPS AND NO ELECTRICITY WAS BEEN APPLIED, THE INTENDED PROCEDURE WAS CONCLUDED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828205 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT THE SINGLE-USE 2-LUMEN SPHINCTEROTOME¿S KNIFE BROKE WHEN THE HANDLE WAS OPERATED USING THE DEVICE. THE ISSUE OCCURRED DURING A THERAPEUTIC BILIARY ENDOSCOPY SPHINCTEROTOMY. THE KNIFE DID NOT FALL OUT OF THE BODY. THE INTENDED PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554617 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME INCISION FUNCTION SUDDENLY BECAME IMPOSSIBLE AND THE WIRE WAS FOUND TO HAVE BEEN BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC THORACIC SYMPATHECTOMY (ETS) PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473000 ↗
• MalfunctionJun 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE LUMEN SPHINCTEROTOME HAD A KNIFE WIRE THAT WAS ALREADY CUT. THE ISSUE OCCURRED DURING AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. 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 19445829 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED, THE KNIFE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS BROKEN. THE ISSUE HAPPENED DURING AN ENDOSCOPIC SPHINCTEROTOMY THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372629 ↗
• MalfunctionFeb 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE KNIFE COATING OF THE SPHINCTEROTOME WAS BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC SPHINCTEROTOMY. NORMAL SETTINGS WERE USED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711383 ↗
• MalfunctionDec 1, 2023Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SPHINCTEROTOME WAS IN USE WITH AN ELECTROSURGICAL UNIT IN ENDOCUT MODE. THE CUSTOMER REPORTED THE SPHINCTEROTOME KNIFE WIRE BROKE. THE CUSTOMER COULD NOT CONFIRM WHETHER IT FELL OFF. THE SPHINCTEROTOME WAS CHANGED TO ANOTHER DEVICE AND THE THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY WAS COMPLETED WITH A SIMILAR DEVICE. THE CUSTOMER REPORTED THE SPHINCTEROTOME WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. NO ADVERSE EFFECTS TO PATIENT REPORTED. NO ADDITIONAL PROCEDURE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248370 ↗
• MalfunctionNov 14, 2023Break; Break

  THE CUSTOMER REPORTED THE KNIFE OF THE SPHINCTEROTOME BROKE OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. WHEN THE SURGEON WAS CUTTING THE PAPILLA, THE KNIFE SUDDENLY BROKE OFF. THE HANDLE OF THE CLEVERCUT WAS REMOVED AND THE SURGEON INSERTED A CATHETER TO THE PLASTIC SHEATH OF THE CLEVERCUT BEFORE REMOVING IT FROM THE SCOPE IN ORDER TO PROTECT THE PATIENT AND THE SCOPE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129479 ↗
• MalfunctionOct 16, 2023Peeled/Delaminated; Peeled/Delaminated

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), (3) SINGLE USE 3-LUMEN SPHINCTEROTOME V WERE USED TO COMPLETE A PROCEDURE. WHEN THE FIRST SPHINCTEROTOME WAS INSERTED INTO THE TJF SCOPE, THE MEDICAL STAFF SAW THE CLEVERCUT COATING WAS CRACKED THROUGH THE ENDOSCOPIC VIEW. THE DEVICE WAS REMOVED AND A NEW DEVICE OPENED. THE SECOND SPHINCTEROTOME WAS INSERTED INTO THE TJF SCOPE, THEY SAW THAT THE CLEVERCUT COATING WAS ALSO CRACKED. THE PROCEDURE WAS COMPLETED BY USING A THIRD SPHINCTEROTOME. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940285 ↗
• MalfunctionOct 16, 2023Peeled/Delaminated; Peeled/Delaminated

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), (3) SINGLE USE 3-LUMEN SPHINCTEROTOME V WERE USED TO COMPLETE A PROCEDURE. WHEN THE FIRST SPHINCTEROTOME WAS INSERTED INTO THE TJF SCOPE, THE MEDICAL STAFF SAW THE CLEVERCUT COATING WAS CRACKED THROUGH THE ENDOSCOPIC VIEW. THE DEVICE WAS REMOVED AND A NEW DEVICE OPEN. THE SECOND SPHINCTEROTOME WAS INSERTED INTO THE TJF SCOPE, THEY SAW THAT THE CLEVERCUT COATING WAS ALSO CRACKED. THE PROCEDURE WAS COMPLETED BY USING A THIRD SPHINCTEROTOME. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939857 ↗
• MalfunctionAug 29, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WAS INSPECTED BEFORE USE AND THE TIP KNIFE WAS BROKEN. THE ISSUE WAS FOUND DURING PROCEDURE, AND THE THERAPEUTIC PROCEDURE (EST) WAS COMPLETED WITH ANOTHER SINGLE USE 3-LUMEN SPHINCTEROTOME V DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647462 ↗
• MalfunctionAug 16, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE BROKE DURING THE FIRST ENERGIZATION. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559764 ↗
• MalfunctionAug 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V TIP KNIFE WIRE WAS CUT WHEN PRODUCT WAS OPENED IN THE PRE-USE INSPECTION. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484806 ↗
• MalfunctionJul 25, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE KNIFE WAS TORN DUE TO ENERGIZATION. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389663 ↗
• MalfunctionJul 14, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC PAPILLARY SPHINCTEROTOMY WHEN THE KNIFE WIRE WAS ENERGIZED, IT BROKE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330282 ↗
• MalfunctionFeb 14, 2023Break; Break

  AS REPORTED FOR THIS EVENT BY THE DISTRIBUTOR, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) WHEN A HIGH FREQUENCY WAS OUTPUT, THE DEVICE KNIFE WIRE BROKE, BUT DID NOT FALL OFF, AT THE FIRST ENERGIZATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME MODEL. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE MODE AT THE TIME OF THE EVENT IS UNKNOWN, BUT THE LIKELY MODE MAY HAVE BEEN EITHER END CUT 1 EFFECT 3 INCISION TIME 3 OR INCISION INTERVAL FORCED COAGULATION EFFECT 2, MAXIMUM WATTAGE 40.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375674 ↗
• MalfunctionSep 24, 2022Break; Break

  AS REPORTED, WHEN ENERGIZED TO PERFORM A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, IT WAS NOT ENERGIZED AT THE TIME OF THE FIRST OUTPUT. THE INTENDED PROCEDURE HOWEVER, WAS COMPLETED USING ANOTHER SIMILAR DEVICE (KD-V411M-0720). THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. ACCORDING TO THE REPORTER, THE HIGH FREQUENCY (HF) UNIT USED WITH THE SUBJECT DEVICE NOTED TO BE MODEL VIO300D. ENERGIZATION TIME (AVERAGE) IS 1 SECOND OR LESS. DEVICE EVALUATION FOUND THE KNIFE WIRE WAS BROKEN. THIS REPORT IS BEING SUBMITTED FOR BROKEN KNIFE WIRE FOUND ON DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481376 ↗
• MalfunctionNov 9, 2018Fluid/Blood Leak

  WHEN INJECTING DYE INTO THE SPHINCTEROTOME, A LEAK IN THE TOME WAS NOTED. THE SPHINCTEROTOME HAD TO BE REMOVED AND A NEW ONE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8054582 ↗