BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURLOK FLATWIRE STONE BASKET, 4-WIRE, 16 MM

    MDR report key: 1203456 · Received October 17, 2008

    Report

    Report Number
    2183680-2008-00027
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 16, 2008
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE DEVICE HAS FOUND A SOLDER JOINT BOND FAILURE. THE DISTAL END OF THE BASKET CAME UNDONE FROM THE WIRE SHEATH. ALL PARTS WERE RECOVERED FROM THE PATIENT.

    Description of Event or Problem · 1

    DURING A STONE RETRIEVAL PROCEDURE, THE SURLOK STONE BASKET BROKE OFF INSIDE THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE BASKET WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURLOK FLATWIRE STONE BASKET, 4-WIRE, 16 MM SURLOK FLATWIRE STONE BASKET FFL GYRUS MEDICAL INC. 5710005 8171094

    Patients

    Seq Age Sex Outcome Treatment
    1