BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURLOCK

    MDR report key: 1170064 · Received September 19, 2008

    Report

    Report Number
    MW5008364
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    CYRUS ACMI
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A URETEROSCOPY STONE EXTRACTION, THE BASKET TIP BROKE OFF DURING THE CASE, TIP RETRIEVED AND REMOVED FROM PT WITH NO APPARENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURLOCK FLAT WIRE STONE BASKET FFL CYRUS ACMI 8171094

    Patients

    Seq Age Sex Outcome Treatment
    1 Other