Single Use 3-Lumen Sphincterotome V KD-V411M-1530 (REF N1090030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170184093), received between Dec 14, 2021 and Nov 9, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Break; Break

  A CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST), THE KNIFE WIRE OF A 3-LUMEN SPHINCTEROTOME V BROKE WHEN THE INCISION WAS ENERGIZED. THE OUTPUT SETTINGS WERE THE DEFAULT SETTINGS. 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 18108164 ↗
• MalfunctionSep 29, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, WHEN THE MEDICAL STAFF OPENED A SINGLE USE 3-LUMEN SPHINCTEROTOME V, THE KNIFE WIRE APPEARED TO BE BENT. THE SUBJECT DEVICE WAS CONTINUED TO BE USED AND THE KNIFE WIRE BROKE AT THE START OF OUTPUTTING. THERE WAS NO SHEDDING INSIDE THE PATIENT¿S BODY. THE THERAPEUTIC ENDOSCOPIC PAPILLOTOMY 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 17848230 ↗
• MalfunctionSep 26, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE BROKE WHEN USING THE PAPILLARY INCISION. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE, WHILE USING THE PULSE CUT SLOW FUNCTIONAL MODE. THE PROCEDURE WAS COMPLETED WITH A SECOND REPLACEMENT DEVICE AFTER A SIMILAR FAILURE. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6). FOR THE REPLACEMENT DEVICE THAT ALSO FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821166 ↗
• MalfunctionSep 24, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT THE KNIFE WIRE WAS BROKEN WHEN USING PAPILLARY INCISION ON THE SINGLE USE 3-LUMEN SPHINCTEROTOME V DURING THE PROCEDURE. THE INTENDED THERAPEUTIC ENDOSCOPIC SLEEVE GASTROPLASTY (EST) PROCEDURE WAS COMPLETED USING A THIRD SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS RELATED TO PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17805395 ↗
• MalfunctionMay 8, 2023Fracture; Fracture

  AS REPORTED, THE KNIFE FRACTURED AT THE TIMING OF THE FIRST ENERGIZATION. OUTPUT SETTING NOTED TO BE UNKNOWN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC PAPILLARY SPHINCTEROTOMY (EST) PROCEDURE. THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO INJURY REPORTED DUE TO THE EVENT. NO USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887592 ↗
• MalfunctionDec 13, 2022Break; Melted; Break; Melted

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) THE TIP KNIFE WIRE (SINGLE USE 3-LUMEN SPHINCTEROTOME V) BROKE. NO DEBRIS FELL OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15972585 ↗
• MalfunctionMay 20, 2022Break; Break

  AS REPORTED, DURING THE EST (ENDOSCOPIC SPHINCTEROTOMY) PROCEDURE THE KNIFE WIRE OF THE DEVICE BROKE WHEN ENERGIZED. 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. THE TYPE AND SETTING OF THE ELECTRIC KNIFE USED IS UNKNOWN (ELECTROSURGICAL UNIT ) USED AND OUTPUT VALUE ARE UNKNOWN. NOT PROVIDED.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460483 ↗
• MalfunctionMay 16, 2022Break; Break

  AS REPORTED, DURING AN EST (ENDOSCOPIC SPHINCTEROTOMY) THERAPEUTIC PROCEDURE THE KNIFE WIRE OF THE DEVICE BROKE WHEN ENERGIZED. THE PATIENT WAS EXPOSED DURING THE CASE , THE OUTPUT PERFORMED , KNIFE WAS ACTIVATED OUTSIDE THE PATIENT. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE. NO HEALTH HAZARD HAS OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH NO HARM OR INJURY TO THE PATIENT. NO USER INJURY REPORTED. THE HF (ELECTROSURGICAL UNIT ) USED AND OUTPUT VALUE ARE UNKNOWN. NOT PROVIDED. THE DEVICE WAS INSPECTED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14413875 ↗
• MalfunctionDec 14, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE NON-HEALTHCARE PROFESSIONAL THAT DURING AN ENDOSCOPIC RETROGRADE COLANGIOPANCREATOGRAPHY USING THE SUBJECT DEVICE, THE CUTTING WIRE WAS BROKEN OFF ON THE FIRST ACTIVATION.THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006237 ↗