Single Use Sphincterotome V KD-VC433Q-0720 (REF N5778030)Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Sphincterotome V · Class 2
All models of Single Use Sphincterotome V (4)
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 04953170399367), received between Jul 10, 2024 and Jul 10, 2024 — 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.
Reports received per month
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.
MalfunctionJul 10, 2024Break; Break
IT WAS REPORTED, THE SINGLE USE PRELOADED SPHINCTEROTOME THE KNIFE WIRE BROKE IMMEDIATELY AFTER APPLYING HIGH FREQUENCY TO THE SUBJECT DEVICE, IT DID NOT FELL OUT OF THE BODY. THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19710998 ↗
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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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