Single Use 3-Lumen Sphincterotome V KD-V411M-3030 (UDI 04953170380624)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
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170380624), received between Apr 29, 2022 and Apr 29, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
- Detachment of Device or Device Component1
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.
MalfunctionApr 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V BLADE WAS DEFORMED AFTER SEVERAL ATTEMPTS AT CANNULATION DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PHYSICIAN PROCEEDED WITH THE PRECUT AND AFTER REINSERTING THE PAPILLOTOME TO DO SPHINCTEROTOMY, THE BLADE HAD BROKEN OFF IN THE PROXIMAL PART. THE PHYSICIAN EXTRACTED THE PAPILLOTOME AND THE BLADE DETACHED COMPLETELY FROM THE DEVICE AND FELL INTO THE DUODENUM. THE BLADE WAS RETRIEVED VIA RETINA AND ANOTHER PAPILLOTOME WAS USED COMPLETE THE OPERATION SUCCESSFULLY WITH A 10-MINUTE DELAY. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14250299 ↗
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- 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
- 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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