BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEGURA

    MDR report key: 1211823 · Received October 15, 2008

    Report

    Report Number
    1211823
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 4, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS A 3 FR X 90 CM SEGURA STONE BASKET WITH A LARGE CALCULUS INSIDE THE BASKET THAT WAS STUCK IN HER RIGHT URETER. DR. ELECTED TO CUT OFF THE SEGURA BASKET HANDLE AND TERMINATE THE SURGICAL PROCEDURE AFTER MANY ATTEMPTS TO DISLODGE STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEGURA BASKET, STONE RETRIEVAL FFL BOSTON SCIENTIFIC CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR