Single Use 3-Lumen Sphincterotome V KD-V411M-1530 (REF N5411730)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.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170380617), received between Mar 22, 2023 and Mar 22, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Recalls naming this device
- Jan 7, 2026Class IIOpen, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1291-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2023Break; Break
AS REPORTED, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE THE KNIFE WIRE BROKE WHEN THE CURRENT WAS APPLIED. OUTPUT SETTING WAS UNKNOWN. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16594556 ↗
Other Unit, electrosurgical, endoscopic (with or without accessories) devices
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- 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
- 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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