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Single Use Preloaded Sphincterotome V KD-V611M-07301S (REF N4507730)Recalls & reported problems

Olympus Medical Systems Corp. · Class 2

All models of Single Use Preloaded Sphincterotome V (11)

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 04953170345012), received between Feb 1, 2022 and Feb 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • 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.

  • MalfunctionFeb 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED TO OLYMPUS THE CUTTING WIRE ON THE SPHINCTEROTOME V BROKE DURING THE PROCEDURE WHEN BOWED. THERE WAS NO REPORT OF DEATH, OR PATIENT HARM OR INJURIES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13419068 ↗

Other Unit, electrosurgical, endoscopic (with or without accessories) devices

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Sources and updates

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