Single Use 3-Lumen Sphincterotome V KD-V411M-0730 (UDI 04953170382642)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04953170382642), received between Jul 30, 2020 and Apr 19, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THE SPHINCTEROTOME KNIFE WIRE BECAME DAMAGED. THE ISSUE OCCURRED DURING PROCEDURE. THE DEVICE WAS REPLACED WITH A NEW DEVICE OF THE SAME PRODUCT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19147399 ↗
• MalfunctionApr 17, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE SPHINCTEROTOME KNIFE WIRE WAS BROKEN, AND WIRE COATING WAS TORN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19123984 ↗
• MalfunctionNov 20, 2023Break; Sparking; Break; Sparking

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE 3-LUMEN SPHINCTEROTOME KNIFE WIRE WAS DAMAGED AND SPARKS OCCURRED. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE FOR AN ENDOSCOPIC PAPILLARY SPHINCTEROTOMY. DURING THE PROCEDURE THE NIPPLE WAS INCISED ONCE, AND WHEN AN ADDITIONAL INCISION WAS ATTEMPTED, THE KNIFE WIRE BROKE WHEN ELECTRICITY WAS APPLIED. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH SIMILAR EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169896 ↗
• MalfunctionAug 3, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT ON THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE BROKE DURING OUTPUTTING. THE ISSUE WAS FOUND DURING THE THERAPEUTIC ENDOSCOPIC PAPILLOTOMY SPHINCTEROTOMY PROCEDURE, WHICH WAS COMPLETED WITH A REPLACEMENT DEVICE (SIMILAR DEVICE). IT WAS CONFIRMED THAT THERE WAS NO EXFOLIATION INSIDE THE BODY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452469 ↗
• MalfunctionJun 21, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT ON THE SINGLE USE 3-LUMEN SPHINCTEROTOME V, THE TIP OF THE KNIFE WIRE (COATED PART) WAS BROKEN. THE ISSUE WAS FOUND DURING A PROCEDURE, WHICH WAS COMPLETED WITH A REPLACEMENT DEVICE. IT WAS CONFIRMED THAT IT HAD NOT FALLEN OFF. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6) FOR REPLACEMENT DEVICE THAT ALSO MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171696 ↗
• MalfunctionJun 6, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE KNIFE WIRE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME V BROKE DURING FIRST ENERGIZATION. THE ISSUE OCCURRED DURING AN ENDOSCOPIC PAPILLOTOMY. THE WIRE WAS STILL ATTACHED TO THE DEVICE WITHOUT FALLING OUT OF IT. NO PRE-USE INSPECTION WAS PERFORMED. THE HIGH FREQUENCY MODE WAS INCISION, BUT THE SET VALUE COULD NOT BE CONFIRMED. THE HIGH-FREQUENCY CAUTERIZATION POWER SUPPLY USED WAS: VIO300D. THE PROCEDURE WAS COMPLETED WITH ANOTHER IDENTICAL PRODUCT, AND THERE WAS NO HARM TO THE PATIENT¿S HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069551 ↗
• MalfunctionJan 30, 2023Break; Break

  THE OLYMPUS REPRESENTATIVE REPORTED THAT DURING A THERAPEUTIC DUODENAL PAPILLOTOMY (EST) PROCEDURE, THE SINGLE-USE 3-LUMEN SPHINCTEROTOMY V KNIFE WIRE HAD BROKEN WHILE BEING USED WITH THE ESG-100/ELECTROSURGICAL GENERATOR. THE SETTING ON THE HIGH-FREQUENCY CAUTERIZATION POWER SUPPLY ON THE ESG-100 WAS NOT REPORTED. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16268815 ↗
• MalfunctionJan 27, 2023Break; Break

  THE OLYMPUS REPRESENTATIVE REPORTED THAT DURING A THERAPEUTIC ENDOSCOPY PAPILLOTOMY PROCEDURE, THE SINGLE-USE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE HAD BROKEN WHILE BEING USED WITH THE SOMA ERBE VIO 200S/ELECTROSURGICAL UNIT. THE TYPE AND SETTING OF THE HF (HIGH FREQUENCY) ABLATION UNIT USED ARE UNKNOWN AND WERE NOT PROVIDED. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16257596 ↗
• MalfunctionJul 26, 2022Break; Break

  IT WAS REPORTED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) THERAPEUTIC PROCEDURE, THE TIP KNIFE BROKE DURING OUTPUT. THE DEVICE WAS REPLACED. THE INTENDED PROCEDURE WAS COMPLETED WITH SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. OUTPUT SETTING OF THE ESG-100 (ELECTROSURGICAL GENERATOR) WAS PULSE/CUT SLOW 80.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100725 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER, DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE TIP KNIFE WIRE BROKE ON THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WHILE BEING USED WITH A NON-OLYMPUS SCOPE. NO DEBRIS HAD FALLEN OFF. THE HIGH FREQUENCY POWER SUPPLY MODEL, SETTING MODE, AND OUTPUT VALUE WERE UNKNOWN. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT HARM REPORTED. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278088 ↗
• MalfunctionApr 29, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER, THE WIRE BROKE ON THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WHILE OPERATING THE STEERING WHEEL AND OUTPUTTING HIGH FREQUENCY SEVERAL TIMES BY LIGHTLY STEPPING ON THE FOOT SWITCH. THE SPHINCTEROTOME WAS NOT ENERGIZED BY HITTING SOMETHING. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THERE WAS NO IMPACT ON THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250443 ↗
• MalfunctionApr 14, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE DEVICE KNIFE BROKE WITH ENERGIZATION DURING ENDOSCOPIC SPHINCTEROTOMY (EST) CONSTRUCTION. THE HIGH FREQUENCY POWER SUPPLY AND OUTPUT SETTINGS USED IN THE COMBINATION ARE UNKNOWN. THE PROCEDURE WAS COMPLETED USING A NEW SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115150 ↗
• MalfunctionSep 24, 2020Break; Break

  DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST), THE SUBJECT DEVICE WAS USED. THE CUTTING WIRE OF THE SUBJECT DEVICE BROKE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10578539 ↗
• MalfunctionJul 30, 2020Break; Break

  DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST), THE SUBJECT DEVICE WAS USED. THE CUTTING WIRE OF THE SUBJECT DEVICE BROKE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE CUTTING WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10342667 ↗