Single Use 3-Lumen Sphincterotome V KD-V411M-0725 (UDI 04953170184031)Recalls & reported problems
Olympus Medical Systems Corp. · Single Use 3-Lumen Sphincterotome V · Class 2
All models of Single Use 3-Lumen Sphincterotome V (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus Sphincterotome V is a single-use cutting tool used in endoscopic bile duct procedures. Of the 160 reports, 138 are malfunctions, and many describe the cutting wire breaking, with some describing melting or sparking. The reports include no deaths and 22 injuries, and reports fell to 10 in the last 12 months from 35 before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 160
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 160 adverse event reports that list this exact device (DI 04953170184031), received between Dec 24, 2019 and Sep 22, 2026 — classified as 22 injuries, 138 malfunctions.
The most frequently reported specific device problem is “Break” (129 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.
Reports received per month
Most reported problems
Device problems
- Break129
- Detachment of Device or Device Component13
- Adverse Event Without Identified Device or Use Problem10
- Melted6
- Sparking4
- Peeled/Delaminated3
- Material Split, Cut or Torn2
- Thermal Decomposition of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions142
- No Consequences Or Impact To Patient6
- Pancreatitis6
- Hemorrhage/Blood Loss/Bleeding4
- Unspecified Hepatic or Biliary Problem3
- Perforation2
- Abscess1
- Cholangitis1
Recent adverse event reports
The 25 most recent of 160 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862694 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME'S WIRE IS FRACTURED. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926856 ↗MalfunctionApr 14, 2026Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME KNIFE WIRE WAS BROKEN. THE ISSUE WAS FOUND WHEN REMOVING THE DEVICE FROM THE BOX. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874062 ↗MalfunctionJan 27, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24190645 ↗MalfunctionJan 27, 2026Break
IT WAS REPORTED THE SINGLE-USE SPHINCTEROTOME'S KNIFE TIP WAS FRACTURED. THIS OCCURRED DURING SET-UP FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189720 ↗MalfunctionJan 21, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24135696 ↗MalfunctionDec 26, 2025Break; Break
IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME V EXHIBITED KNIFE WIRE IS FRACTURED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23899017 ↗MalfunctionDec 11, 2025Break; Break
ADDITIONAL INFORMATION PROVIDED: IT WAS REPORTED THAT THE KNIFE WIRE WAS FRACTURED UPON INITIAL OPENING OF THE BOX (OOB) AND HAD NOT BEEN USED BY THE USER. UPON RETURN OF THE DEVICE, THE VISUAL INSPECTION CONCLUDED THAT THE DEVICE HAD BEEN UTILIZED AND ENERGIZED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777602 ↗MalfunctionNov 13, 2025Break; Fracture; Break; Fracture
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542885 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT THE KNIFE WIRE ON THE SPHINCTEROTOME FRACTURED. THE EVENT OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ECRP) AND THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510167 ↗MalfunctionSep 16, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE KNIFE BOW WAS FRACTURED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITH PROCEDURAL DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23067043 ↗MalfunctionSep 16, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE KNIFE WIRE WAS FRACTURED. THIS ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066611 ↗MalfunctionSep 16, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE KNIFE WIRE WAS FRACTURED. THIS ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066503 ↗MalfunctionAug 26, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22896923 ↗MalfunctionAug 21, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22861949 ↗MalfunctionAug 18, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22830745 ↗MalfunctionAug 15, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22817244 ↗MalfunctionAug 1, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686276 ↗MalfunctionJul 8, 2025Break; Break
THE CUSTOMER REPORTED THAT AN OLYMPUS SINGLE-USE SPHINCTEROTOME KNIFE WIRE FRACTURED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THIS FAILURE OCCURRED WHILE THE DEVICE WAS INSIDE THE PATIENT AND THE PATIENT WAS UNDER SEDATION. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING A BACK-UP OLYMPUS DEVICE WITH NO PATIENT INJURIES OR ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22435807 ↗MalfunctionJun 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE 3-LUMEN SPHINCTEROTOME EXHIBITED MUCUS ADHERING TO THE SURFACE OF THE DISTAL END OF THE KNIFE WIRE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293893 ↗MalfunctionJun 6, 2025Break; Break
IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME HAD A BLADE FRACTURE. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND THE PROCEDURE WAS COMPLETED WITH A BACKUP OLYMPUS DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22161577 ↗MalfunctionMay 28, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22098643 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE. CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE KNIFE WIRE HAD BROKEN. 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 22026897 ↗MalfunctionMay 5, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE HAD A FRACTURE OF THE KNIFE BLADE DURING SURGERY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21960774 ↗MalfunctionApr 29, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE KNIFE WIRE BROKE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926490 ↗
Other Unit, electrosurgical, endoscopic (with or without accessories) devices
- THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip TB-0535FCOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)1 recall2 deaths404 reports
- SONICBEAT 5 mm, 35 cm, Front-actuated Grip SB-0535FCOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)379 reports
- Single Use Electrosurgical Knife KD-611LOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)1 death357 reports
- Autotome™ RX 44 M00545170Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall262 reports
- TRUEtome 44 M00584170Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)237 reports
- Dreamtome™ RX 44 M00584040Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall165 reports
- Dreamtome™ RX 44 M00584050Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall127 reports
- Hydratome RX 44 M00583040Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall98 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page