Single Use 3-Lumen Sphincterotome V KD-V411M-0725 (REF N5411430)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 an endoscopic cutting device. Of its 78 reports, 77 are malfunctions and 1 is an injury, with no deaths. Most describe parts breaking, such as the cutting wire or blade, and some describe peeling, tears or melting. There is 1 open recall, from January 2026, for units that were not thermoformed and could lose performance. Reports fell to 1 in the last 12 months from 16 in the prior 12 months.
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
- 77
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 04953170380587), received between Jan 6, 2021 and Sep 16, 2025 — classified as 1 injury, 76 malfunctions.
The most frequently reported specific device problem is “Break” (65 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-1273-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break65
- Material Split, Cut or Torn6
- Peeled/Delaminated5
- Melted4
- Detachment of Device or Device Component2
- Thermal Decomposition of Device2
- Device Contamination with Chemical or Other Material1
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23064769 ↗MalfunctionSep 15, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE KNIFE CUTTING WIRE BROKE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23052515 ↗MalfunctionSep 9, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23012403 ↗MalfunctionAug 28, 2025Break; Break
IT WAS REPORTED DURING A SPHINCTEROTOMY PROCEDURE, THE SPHINCTEROTOME BLADE BROKEN DURING CUTTING. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911313 ↗MalfunctionAug 19, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE CUTTING WIRE IS BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22845446 ↗MalfunctionAug 13, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797812 ↗MalfunctionJul 28, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22638967 ↗MalfunctionJul 17, 2025Break; Break
IT WAS REPORTED THE LUMEN SPHINCTEROTOME WIRE BROKE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22530656 ↗MalfunctionMay 9, 2025Break; Break
IT WAS REPORTED DURING A THERAPEUTIC PAPILLOTOMY PROCEDURE; THE ENERGY WAS ADAPTED TO THE DEVICE AND THE WIRE OF THE SUBJECT DEVICE GOT BROKEN. THEY WROTE THAT THEY WERE FAR ENOUGH FROM THE ALBARAN LEVER. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997646 ↗MalfunctionApr 24, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME V HAD KNIFE BURN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY AND THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21901125 ↗MalfunctionApr 1, 2025Break; Break
IT WAS REPORTED THAT SPHINCTEROTOME HAD A BROKEN KNIFE WIRE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21745273 ↗MalfunctionMar 5, 2025Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device
IT WAS REPORTED THAT THE KNIFE WIRE ON THE SPHINCTEROTOME BURNED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21530000 ↗MalfunctionFeb 21, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE CUTTING WIRE BROKE WHILE THE CURRENT PASSED AT THE TIME OF THE SPHINCTEROTOMY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP). THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21439093 ↗MalfunctionDec 10, 2024Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20896707 ↗MalfunctionDec 5, 2024Break; Break
IT WAS REPORTED, THE SUBJECT DEVICE HAD THE KNIFE WIRE BROKEN DURING A THERAPEUTIC PAPILLOTOMY, WITH PATIENT UNDER SEDATION. THERE WAS NO DROPOUT FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED 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 20853953 ↗MalfunctionNov 18, 2024Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20712183 ↗MalfunctionOct 25, 2024Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE KNIFE WIRE OF THE SPHINCTEROTOME TOUCHED METAL WHILE BEING ACTIVATED AND BROKE. THE BROKEN PART WAS BURNT AND MELTED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20534885 ↗MalfunctionOct 24, 2024Break; Break
IT WAS REPORTED THAT THE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE BROKE WHILE CUTTING THE NIPPLE. IT DID NOT FALL OUT INSIDE THE BODY. A SEPARATE STOCK WAS OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THE ISSUE OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS THERAPEUTIC. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20522756 ↗MalfunctionOct 23, 2024Break; Break
IT WAS REPORTED, THE SPHINCTEROTOME V EXHIBITED A DAMAGED KNIFE WIRE. THE ISSUE OCCURED DURING A THERAPEUTIC EST 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 20514220 ↗MalfunctionOct 11, 2024Break; Break
IT WAS REPORTED THE 3-LUMEN SPHINCTEROTOME KNIFE WIRE BROKE AFTER TWO ELECTRICAL CURRENTS. THE ISSUE OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433355 ↗MalfunctionOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, THE KNIFE WIRE AT THE TIP OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME V HAD COME OFF AND WAS STICKING OUT. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20378309 ↗MalfunctionSep 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE KNIFE WIRE WAS DAMAGED. THE PRODUCT WAS CUT WHEN IT WAS INSERTED INTO THE SCOPE, THE TIP WAS REMOVED, AND THE KNIFE WAS TENSIONED. THE DOCTOR REPLACED IT WITH ANOTHER PRODUCT OF THE SAME MODEL NUMBER AND COMPLETED THE PROCEDURE. THE ISSUE OCCURRED DURING AN ELECTROSHOCK THERAPY (EST) . THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280594 ↗MalfunctionSep 18, 2024Break; Break
IT WAS REPORTED, THE SINGLE USE 3-LUMEN SPHINCTEROTOME'S KNIFE WIRE BROKE. THE ISSUE OCCURRED DURING AN THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. THE WIRE DID BREAK INSIDE OF THE PATIENT BUT IT DID NOT FALL OUT. THERE WERE NO REPORTS OF PATIENT HARM AND THE INTENDED PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED USING A SIMILAR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20245974 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WAS BROKEN AND DID NOT TURN ON. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20223833 ↗MalfunctionSep 10, 2024Break; Break
IT WAS REPORTED, WHEN ELECTRICITY WAS APPLIED DURING THE THERAPEUTIC BILIARY ENDOSCOPIC SPHINCTEROTOMY (EST) NIPPLE INCISION, THE KNIFE WIRE BROKE WHEN IT WAS BEING CUT. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20179549 ↗
Other Unit, electrosurgical, endoscopic (with or without accessories) devices
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- 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
- 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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