Single Use 3-Lumen Sphincterotome V KD-V411M-0720 (UDI 04953170184017)Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 04953170184017), received between Nov 22, 2019 and Aug 26, 2025 — classified as 1 death, 1 injury, 60 malfunctions.

The most frequently reported specific device problem is “Break” (51 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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE CUTTING WIRE WAS BROKEN AT PROXIMAL END SITE AND THERE WAS DAMAGE TO THE COATED PORTION OF THE SUBJECT DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895496 ↗
• MalfunctionJun 6, 2025Break; Break

  OIYMPUS RECEIVED A REPORT FROM THE CUSTOMER INDICATING THAT THE SINGLE-USE SPHINCTEROTOME KNIFE WIRE WAS FOUND BROKEN DURING PROCEDURE PREPARATION. HOWEVER, DURING THE DEVICE EVALUATION, MUCUS WAS DISCOVERED ON THE SUBJECT DEVICE, CONFIRMING USAGE. CONSEQUENTLY, THE CUSTOMER¿S REPORT OF THE BROKEN KNIFE WIRE IS CONSIDERED A REPORTABLE MALFUNCTION AS A RESULT OF THE DEVICE INVESTIGATION. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159573 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE CUTTING KNIFE WIRE OF THE SINGLE-USE, 2-LUMEN SPHINCTEROTOME HAD MELTED AT THE INSULATING COATING SECTION. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152694 ↗
• MalfunctionNov 5, 2024Break; Break

  THE ISSUE OCCURRED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), WHICH WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611677 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE 2-LUMEN SPHINCTEROTOME KNIFE WIRE WAS BROKEN. THE ISSUE OCCURRED DURING PREPARATION FOR USE IN A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463453 ↗
• MalfunctionOct 9, 2024Break; Break

  THE CUSTOMER REPORTED THAT WHILE PASSING AN OLYMPUS SINGLE-USE 3-LUMEN SPHINCTEROTOME V THROUGH AN ENDOSCOPE, THE PHYSICIAN NOTED THAT THE KNIFE WIRE HAD BROKEN. ACCORDING TO THE INITIAL REPORTER, IT DID NOT FALL OFF INSIDE THE BODY. REPORTEDLY, THE PHYSICIAN REPLACED THE DEVICE WITH ANOTHER AND COMPLETED THE PROCEDURE WITHOUT ANY IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407643 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME WIRE WAS CUT WHEN ELECTRICAL ENERGY WAS TRANSMITTED THROUGH IT. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY PROCEDURE. THERE WAS A 5-15 MINUTE DELAY WHILE THE PATIENT WAS SEDATED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152373 ↗
• MalfunctionAug 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, THE LUMEN SPHINCTEROTOME EXHIBITED THE WIRE OF THE ARCHED PAPILLOTOME WAS CUT WHEN TRANSMITTING ELECTRIC CURRENT TO PERFORM PAPILLOTOMY. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19956422 ↗
• MalfunctionAug 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 3-LUMEN SPHINCTEROTOME V EXHIBITED A DEVICE WIRE CUTTING OFF WHEN TRANSMITTING AN ELECTRICAL CURRENT. THE ISSUE OCCURRED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR NEW DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919011 ↗
• MalfunctionJun 13, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A THERAPEUTIC, EST PROCEDURE, THE BLADE OF THE SPHINCTEROTOME DID NOT COME OUT SMOOTHLY. IT WAS DISCOVERED THE COATING WAS TORN. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528778 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192932 ↗
• MalfunctionApr 1, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ADDITIONAL INFORMATION FROM THE CUSTOMER STATED THAT THE PROCEDURE WAS THERAPEUTIC WITH NO DELAY AND WAS COMPLETED WITHOUT PATIENT INJURY NOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015638 ↗
• MalfunctionMar 15, 2024Break; Break

  IT WAS REPORTED THAT THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR A STENT EXCHANGE AND WAS COMPLETED USING A SIMILAR SET OF EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912790 ↗
• MalfunctionJan 24, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V HAD THE KNIFE WIRE BREAK. THE EVENT OCCURRED DURING A PROCEDURE. THE PROCEDURE WAS CONTINUED AND WAS COMPLETED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572072 ↗
• MalfunctionJan 5, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE SINGLE USE 2-LUMEN SPHINCTEROTOME, TWO CONSECUTIVE KNIFE WIRES BROKE WHEN THE HIGH FREQUENCY WAS APPLIED. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE, ENDOSCOPIC SPHINCTEROTOMY (EST) WAS COMPLETED USING A SIMILAR DEVICE AFTER A THIRD TRY. THE HIGH FREQUENCY EQUIPMENT AND SETTINGS USED WERE NOT IMMEDIATELY KNOWN. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED ISSUE. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460317 ↗
• MalfunctionDec 4, 2023Break; Break

  AN OLYMPUS SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KNIFE WIRE OF THE KD-V411M-0720/SINGLE USE 3-LUMEN SPHINCTEROTOME V BROKE (NO FALLING OFF). THE ISSUE WAS FOUND DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE FACILITY REPLACED IT WITH ANOTHER SIMILAR AND COMPLETED THE INTENDED PROCEDURE. THERE WERE NO REPORTED DELAYS. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257222 ↗
• MalfunctionNov 20, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V HAD A BROKEN KNIFE WIRE TIP. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAYS. THERE WERE NO REPORTS OF PATIENT OR USE HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170702 ↗
• MalfunctionOct 12, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE 3-LUMEN SPHINCTEROTOME V EXPERIENCED DIFFICULTY/RESISTANCE WHEN REMOVING THE WIRE WHICH LED TO WIRE DEFORMATION/DAMAGE. ADDITIONALLY, THE USER REPORTED IN THE NORMAL POSITION, THE WIRE MUST PASS THROUGH SCOPE¿S INSTRUMENT CHANNEL AND WHILE INSERTING IN PAPILLA, IT WAS DIFFICULT TO PUSH AS THE CUTTING WIRE WAS GOING OUT OF SHAPE. THE PROCEDURE WAS COMPLETED WITH A NON-OLYMPUS SIMILAR DEVICE SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920995 ↗
• DeathSep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " SHORT AND LONG OUTCOMES OF ENDOSCOPIC BILATERAL METAL STENT PLACEMENT FOR MALIGNANT HILAR BILIARY OBSTRUCTION: TERTIARY CARE ONCOLOGY CENTRE EXPERIENCE." LITERATURE SUMMARY A RETROSPECTIVE STUDY ASSESSED THE SHORT AND LONG-TERM OUTCOMES OF PATIENTS UNDERGOING SELF-EXPANDING METAL STENTS (SEMS) AND BILATERAL SELF-EXPANDING METAL STENTS (SEMS) PLACEMENT FOR COMPLEX HILAR BLOCKS. A TOTAL OF 43 PATIENTS WERE INCLUDED WITH A MEAN AGE OF 54.9 YEARS WITH 51.2% OF FEMALES. MEDIAN CHARLSON COMORBIDITY INDEX WAS 7 WITH 21 (48.8%) HAVING UNDERLYING COMORBIDITIES, INDICATING A SUSPECTED 10-YEAR SURVIVAL RATE OF 0.01%. TECHNICAL SUCCESS WAS 95.3% OF PATIENTS AND FUNCTIONAL SUCCESS WAS 95.1% OF PATIENTS. ON CHOLANGIOGRAM, 26 (60.4%) HAD BISMUTH TYPE II BLOCK, 12 (27.8%) HAD TYPE IIIA/B, AND 5 (11.6%) HAD TYPE IV BLOCK. ONE PATIENT HAD DELAYED RESOLUTION OF JAUNDICE AFTER STENT PLACEMENT AND IN ANOTHER PATIENT, MORTALITY OCCURRED WITHIN 30 DAYS, WHICH PRECLUDED THE ASSESSMENT OF FUNCTIONAL SUCCESS. NORMALIZATION OF BILIRUBIN OCCURRED IN 35 PATIENTS WHO FURTHER RECEIVED TUMOR-DIRECTED THERAPY. COMPLICATIONS WERE MANAGED CONSERVATIVELY. THE MEDIAN

  Patient problems: Thromboembolism

  MAUDE report 17803228 ↗
• MalfunctionSep 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE KNIFE WIRE TIP BROKE. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC BILIARY 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 17801881 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " SHORT AND LONG OUTCOMES OF ENDOSCOPIC BILATERAL METAL STENT PLACEMENT FOR MALIGNANT HILAR BILIARY OBSTRUCTION: TERTIARY CARE ONCOLOGY CENTRE EXPERIENCE." LITERATURE SUMMARY: A RETROSPECTIVE STUDY ASSESSED THE SHORT AND LONG-TERM OUTCOMES OF PATIENTS UNDERGOING SELF-EXPANDING METAL STENTS (SEMS) AND BILATERAL SELF-EXPANDING METAL STENTS (SEMS) PLACEMENT FOR COMPLEX HILAR BLOCKS. A TOTAL OF 43 PATIENTS WERE INCLUDED WITH A MEAN AGE OF 54.9 YEARS WITH 51.2% OF FEMALES. MEDIAN CHARLSON COMORBIDITY INDEX WAS 7 WITH 21 (48.8%) HAVING UNDERLYING COMORBIDITIES, INDICATING A SUSPECTED 10-YEAR SURVIVAL RATE OF 0.01%. TECHNICAL SUCCESS WAS 95.3% OF PATIENTS AND FUNCTIONAL SUCCESS WAS 95.1% OF PATIENTS. ON CHOLANGIOGRAM, 26 (60.4%) HAD BISMUTH TYPE II BLOCK, 12 (27.8%) HAD TYPE IIIA/B, AND 5 (11.6%) HAD TYPE IV BLOCK. ONE PATIENT HAD DELAYED RESOLUTION OF JAUNDICE AFTER STENT PLACEMENT AND IN ANOTHER PATIENT, MORTALITY OCCURRED WITHIN 30 DAYS, WHICH PRECLUDED THE ASSESSMENT OF FUNCTIONAL SUCCESS. NORMALIZATION OF BILIRUBIN OCCURRED IN 35 PATIENTS WHO FURTHER RECEIVED TUMOR-DIRECTED THERAPY. COMPLICATIONS WERE MANAGED CONSERVATIVELY. THE MEDIAN

  Patient problems: Cholangitis; High Blood Pressure/ Hypertension; Pancreatitis; Unspecified Hepatic or Biliary Problem

  MAUDE report 17801324 ↗
• MalfunctionAug 3, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE BROKE WHEN THE OPERATOR TRIED TO ANGLE THE KNIFE WIRE DURING A THERAPEUTIC PROCEDURE. THE WIRE HAD NOT FALLEN INTO THE PATIENT'S BODY. THE OPERATOR COMPLETED THE PROCEDURE WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450903 ↗
• MalfunctionJul 28, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE CUTTING WIRE (KNIFE WIRE) WAS OUT OF SHAPE. IT WAS NOT POSSIBLE TO ENTER SMOOTHLY, AND THE CUTTING WIRE POSITION WAS NOT PROPER. THE REPORTED ISSUE WAS OBSERVED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITHOUT A DELAY. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE CLEVER CUT COATING OF THE KNIFE WIRE WAS COMPLETELY SHAVED OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING DEVICE EVALUATION (COATING PEELED OFF AND WIRE EXPOSED). ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED ISSUE. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415525 ↗
• MalfunctionJul 16, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE BROKE DURING A THERAPEUTIC ENDOSCOPIC PAPILLARY SPHINCTEROTOMY SURGICAL PROCEDURE. THERE WERE NO WIRES FALLING OUT OF THE BODY AND HIGH FREQUENCY WAS USED AS USUAL WITH VIO3 AND END CUT I. THE PROCEDURE WAS COMPLETED USING ANOTHER IDENTICAL PRODUCT. THE DEVICE WAS NOTED TO HAVE BEEN INSPECTED BEFORE USE. THERE WAS NO REPORT OF DELAY OR HARM TO A PATIENT OR USER ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330879 ↗
• MalfunctionJun 29, 2023Break; Melted; Sparking; Material Split, Cut or Torn; Break; Melted; Sparking; Material Split, Cut or Torn

  ON BEHALF OF THE CUSTOMER, AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE KNIFE WIRE SPARKED AND BROKE WHEN USING SINGLE USE 3-LUMEN SPHINCTEROTOME V. THERE WAS NO DAMAGE OR BURNS. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE ARE NO HEALTH HAZARDS FROM THIS EVENT. THERE WAS NO REPORT OF DELAY OR HARM TO THE PATIENT OR USER ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222684 ↗