BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP STONE RETRIEVAL BASKET

    MDR report key: 1822246 · Received August 12, 2010

    Report

    Report Number
    1822246
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    A STONE RETRIEVAL BASKET BY BOSTON SCIENTIFIC, 1.9 FR. X 120CM, REF 390-105, LOT 13479792, EXP DATE 2012-05, CE 0197, WOULD NOT OPEN WHEN IT WAS INSERTED INTO THE URETER. THE SURGEON CHECKED THE BASKET AFTER IT WAS WITHDRAWN AND IT WAS INTACT. ANOTHER ONE WAS USED WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP STONE RETRIEVAL BASKET STONE BASKET FFL BOSTON SCIENTIFIC * 13479792

    Patients

    Seq Age Sex Outcome Treatment
    1 *