BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH

    MDR report key: 1170305 · Received September 12, 2008

    Report

    Report Number
    1170305
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 9, 2008
    Manufacturer
    UNITED STATES SURGICAL CORP. (COVIDIEN)
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING THE DEVICE IN THE PATIENT AND IT BROKE. THEY TRIED ANOTHER DEVICE AND THE SECOND DEVICE BROKE WHILE THE PHYSICIAN WAS PUTTING IT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH SPECIMEN POUCH GCJ UNITED STATES SURGICAL CORP. (COVIDIEN) 120430 J7D26 J7D26

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR NO OTHER THERAPIES| NO OTHER THERAPIES