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Single Use Preloaded Sphincterotome V KD-V611M-07201SRecalls & 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 04953170403040), received between Jun 8, 2023 and Jun 8, 2023 — 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

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.

  • MalfunctionJun 8, 2023Break; Break

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE WIRE WAS TORN DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THE DEVICE WAS RETURNED TO SERVICE WHERE EVALUATION FOUND THE CUTTING WIRE WAS BROKEN. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND AT EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17088227 ↗

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

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Sources and updates

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