Single Use 2-Lumen Sphincterotome V KD-V211M-0725Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170382734), received between Mar 18, 2023 and Mar 18, 2023 — 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

Recent adverse event reports

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

• InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "LONG-TERM RESULTS OF ENDOSCOPIC METAL STENTING FOR BILIARY ANASTOMOTIC STRICTURE AFTER LIVER TRANSPLANTATION." ANASTOMOTIC BILIARY STRICTURE (ABS) IS A WELL-KNOWN COMPLICATION OF LIVER TRANSPLANTATION WHICH CAN LEAD TO SECONDARY BILIARY CIRRHOSIS AND GRAFT DYSFUNCTION. THE GOAL OF THIS STUDY WAS TO EVALUATE THE LONG-TERM OUTCOMES OF ENDOSCOPIC METAL STENTING OF ABS IN THE SETTING OF DECEASED DONOR LIVER TRANSPLANTATION (DDLT). CONSECUTIVE DDLT PATIENTS WITH ENDOSCOPIC METAL STENTING FOR ABS BETWEEN 2010 AND 2015 WERE SCREENED. DATA ON DIAGNOSIS, TREATMENT AND FOLLOW-UP (UNTIL JUNE 2022) WERE COLLECTED. THE PRIMARY OUTCOME WAS ENDOSCOPIC TREATMENT FAILURE DEFINED AS THE NEED FOR SURGICAL REFECTION. RESULTS: AMONG THE 465 PATIENTS WHO UNDERWENT LT, 41 DEVELOPED ABS. IT WAS DIAGNOSED AFTER A MEAN PERIOD OF 7.4 MONTHS (+/- 10.6) FOLLOWING LT. ENDOSCOPIC TREATMENT WAS TECHNICALLY SUCCESSFUL IN 95.1% OF CASES. THE MEAN DURATION OF ENDOSCOPIC TREATMENT WAS 12.8 MONTHS (+/- 9.1) AND 53.7% OF PATIENTS COMPLETED A 1-YEAR TREATMENT. AFTER A MEAN FOLLOW-UP OF 6.9 YEARS (+/- 2.3), ENDOSCOPIC TREATMENT FAILED IN NINE PATIENTS (22%) WHO REQUIRED S

  Patient problems: Cholangitis; Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 16569796 ↗