Single Use 3-Lumen Sphincterotome V KD-V411M-0730 (REF N5411530)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of Single Use 3-Lumen Sphincterotome V (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus single-use sphincterotome is a thin electrosurgical wire used during endoscopy to cut tissue. Of68 adverse event reports, most describe the wire or tip breaking during procedures, along with material tearing or separating. Five reports mention injuries, and no deaths were reported. One recall started in January 2026 and remains open, because units that skipped a thermoforming step could deform and lose performance.
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
- 71
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 04953170380594), received between Aug 8, 2018 and Sep 30, 2026 — classified as 5 injuries, 66 malfunctions.
The most frequently reported specific device problem is “Break” (59 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.
Reports received per month
Recalls naming this device
- Jan 7, 2026Class IIOpen, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1274-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break59
- Material Split, Cut or Torn6
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component2
- Material Fragmentation2
- Material Separation2
- Melted2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- Hemorrhage/Blood Loss/Bleeding3
- Burn(s)2
- No Consequences Or Impact To Patient2
- Foreign Body In Patient1
- Perforation1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941441 ↗MalfunctionSep 28, 2026Break
It was reported that the cutting wire broke after power activation with the Olympus Single Use Sphincterotome. The issue occurred during a therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure. The procedure was completed using a similar device. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914222 ↗MalfunctionSep 28, 2026Break
It was reported that the cutting wire broke after power activation with the Olympus Single Use Sphincterotome. The issue occurred during a therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure. The procedure was completed using a similar device. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914021 ↗MalfunctionFeb 27, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471497 ↗MalfunctionFeb 27, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471376 ↗MalfunctionFeb 27, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471323 ↗MalfunctionFeb 24, 2026No Apparent Adverse Event
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431280 ↗MalfunctionFeb 19, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388149 ↗MalfunctionAug 21, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22866277 ↗MalfunctionAug 20, 2025Break; Break
IT WAS REPORTED THE SINGLE-USE SPHINCTEROTOME'S WIRE BROKE DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22855447 ↗MalfunctionJul 7, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE STERILE PACKAGING WAS DAMAGED ON 1 PIECE. NO DAMAGE TO OUTER BOX. THE ISSUE OCCURRED AT OUT OF THE BOX FAILURE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22419978 ↗MalfunctionMay 9, 2025Break; Break
IT WAS REPORTED THAT DURING A THERAPEUTIC SPHINCTEROTOMY, THE CUTTING WIRE OF THREE PAPILLOTOMEN BROKE. THERE WERE NO REPORTS OF PATIENT HARM. REPORT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21992800 ↗MalfunctionMay 9, 2025Break; Break
IT WAS REPORTED THAT DURING A THERAPEUTIC SPHINCTEROTOMY, THE CUTTING WIRE OF THREE PAPILLOTOMEN BROKE. THERE WERE NO REPORTS OF PATIENT HARM. REPORT 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21992730 ↗MalfunctionMay 7, 2025Break; Break
IT WAS REPORTED THAT THE KNIFE WIRE OF THE DEVICE WAS BROKEN, AND THE WIRE'S COATING WAS PEELING OFF. IT WAS UNSPECIFIED WHEN THIS EVENT WAS OBSERVED. THERE WAS NO REPORT OF HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21979891 ↗MalfunctionMay 7, 2025Break; Break
IT WAS REPORTED THAT DURING A THERAPEUTIC SPHINCTEROTOMY, THE CUTTING WIRE OF THREE PAPILLOTOMEN BROKE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21978819 ↗MalfunctionMay 2, 2025Material Fragmentation; Material Fragmentation
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21953728 ↗MalfunctionApr 4, 2025Break; Break
IT WAS REPORTED; THE SUBJECT DEVICE WHEN TENSIONING THE WIRE IN THE PAPILLA TO CUT IT, THE WIRE TEARS IN THE PROXIMAL AREA. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE AND WAS COMPLETED USING A SIMILAR DEVICE. NO DELAY AND NO PATIENT HARM WERE REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21778322 ↗MalfunctionFeb 7, 2025Break; Material Fragmentation; Melted; Break; Material Fragmentation; Melted
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SPHINCTEROTOME EXHIBITED THE COVERING OF THE KNIFE WIRE WAS PEELED AND DISLODGED, THE COATED PORTION OF THE CUTTING WIRE WAS TORN AND THE BROKEN PORTION WAS SCORCHED AND MELTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21333901 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME'S CUTTING WIRE WAS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PROCEDURE WAS DELAYED WHILE THE PATIENT WAS UNDER PROPOFOL SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19383376 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME'S CUTTING WIRE WAS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PROCEDURE WAS DELAYED WHILE THE PATIENT WAS UNDER PROPOFOL SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19382675 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME'S CUTTING WIRE WAS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PROCEDURE WAS DELAYED WHILE THE PATIENT WAS UNDER PROPOFOL SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19382364 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME'S CUTTING WIRE WAS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PROCEDURE WAS DELAYED WHILE THE PATIENT WAS UNDER PROPOFOL SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19381723 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME'S CUTTING WIRE WAS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PROCEDURE WAS DELAYED WHILE THE PATIENT WAS UNDER PROPOFOL SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19381553 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME'S CUTTING WIRE WAS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PROCEDURE WAS DELAYED WHILE THE PATIENT WAS UNDER PROPOFOL SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19381385 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME'S CUTTING WIRE WAS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PROCEDURE WAS DELAYED WHILE THE PATIENT WAS UNDER PROPOFOL SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19381267 ↗
Other Unit, electrosurgical, endoscopic (with or without accessories) devices
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- 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
- Single Use 3-Lumen Sphincterotome V KD-V411M-0725Olympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)160 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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