Single Use Preloaded Sphincterotome V KD-V631M-07202S (REF N4508330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170345074), received between Oct 27, 2020 and Oct 27, 2020 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2020Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING ENDOSCOPIC SPHINCTEROTOMY, THE NEEDLE PIERCED THE SHEATH. THE USER WAS UNABLE TO PASS THE DEVICE DOWN AN ENDOSCOPE. NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. ON (B)(6) 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE CUTTING WIRE WAS BROKEN OFF, AND THAT THE BROKEN SECTION OF THE CUTTING WIRE WAS MELTED AND BURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738843 ↗