BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1181716 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04948
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN URETEROSCOPY PROCEDURE, THE BASKET ZERO TIP 2.4MM X 4MM STONE RETRIEVAL BASKET FAILED TO OPEN AND A TEAR WAS NOTED ON THE SHEATH NEXT TO THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC M0063901010 11764584

    Patients

    Seq Age Sex Outcome Treatment
    1