BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK INCORPORATED

    MDR report key: 5597757 · Received April 19, 2016

    Report

    Report Number
    MW5061838
    Event Type
    Injury
    Date Received
    April 19, 2016
    Date of Event
    April 3, 2016
    Report Date
    April 19, 2016
    Manufacturer
    COOK INCORPORATED
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    FIRST BASKET DID NOT OPEN PROPERLY. SECOND BASKET WAS BEING PULLED OUT WITH STONES IN THE BASKET AND IT DETACHED. THIRD BASKET WAS USED TO RETRIEVE SECOND BASKET AND STONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242331 COOK INCORPORATED NCIRCLE STONE RETRACTOR 2.2FR FFL COOK INCORPORATED 918778 6463787
    242332 COOK INCORPORATED NCIRCLE STONE RETRACTOR 2.2FR FFL COOK INCORPORATED 918778 6436111

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention