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Single Use 2-Lumen Sphincterotome V KD-V211M-0720Recalls & reported problems

Olympus Medical Systems Corp. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170382727), received between May 16, 2022 and May 16, 2022 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding1
  • Pancreatitis1
  • Perforation1
  • Unspecified Hepatic or Biliary Problem1

Recent adverse event reports

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

  • InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT IS REPORTED IN THE LITERATURE TITLED "SECOND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AFTER FAILURE OF INITIAL BILIARY CANNULATION: A SINGLE INSTITUTION RETROSPECTIVE EXPERIENCE", PATIENTS EXPERIENCED ADVERSE EVENTS DURING AND/OR AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES USING A SINGLE USE, DOUBLE LUMEN SPHINCTEROTOME. STUDY AIM: THIS RETROSPECTIVE STUDY DESCRIBED THE SECOND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AFTER FAILURE OF INITIAL BILIARY CANNULATION. STUDY METHOD: A TOTAL OF 4,136 ERCPS WERE PERFORMED . OF THESE, 579 (15.2%) ERCPS REFERRED TO DIFFICULT CANNULATION. A TOTAL OF 94 PATIENTS (2.3%) WHO MET THE STUDY INCLUSION CRITERIA WERE IDENTIFIED. ERCP WAS PERFORMED USING A THERAPEUTIC DUODENOSCOPE (PENTAX ED34-I10T 4.2; PENTAX MEDICAL) AND ENDOSCOPIC ACCESSORIES (BOSTON SCIENTIFIC AND OLYMPUS CORPORATION), STANDARD BILIARY CANNULATION WAS PERFORMED WITH THE GUIDEWIRE-ASSISTED TECHNIQUE. A DOUBLE LUMEN PULL-TYPE SPHINCTEROTOME (OLYMPUS) PRELOADED WITH A HYDROPHILIC GUIDEWIRE (HYDRA JAGWIRE; BOSTON SCIENTIFIC) WAS USED IN THIS TECHNIQUE. NEEDLE-KNIFE SPHINCTEROTOMY (NKS) WAS PERFORMED WITH A NEEDLE-KNIFE SPHINCTEROTOME (TRIPLE-LU

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation; Unspecified Hepatic or Biliary Problem

    MAUDE report 14406846 ↗

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

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Sources and updates

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