BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESOURCE CUSTOM STERILE CABG PACK

    MDR report key: 2182887 · Received July 20, 2011

    Report

    Report Number
    2182887
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    SURGICAL TECH REPORTS SMALL LIGACLIP APPLIER CONTAINED IN CUSTOM CARDINAL PRESOURCE PACK WAS BEING USED FOR INTERNAL MAMMARY TAKEDOWN WHEN SURGEON NOTED THE APPLIER SEEMED TO BE SCISSORING BEFORE THE TRIGGER WAS ENGAGED. ISSUE WAS NOTED PRIOR TO USE. NO HARM TO PATIENT. DEVICE REMOVED FROM FIELD AND REPLACED WITH ANOTHER CLIP APPLIER (ALSO INCLUDED IN THE PRESOURCE KIT). CASE FINISHED WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESOURCE CUSTOM STERILE CABG PACK CLIP APPLIER FZP CARDINAL HEALTH SCV45CBNCK *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR