BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECT CUT BULLET-TIP ROTATING AORTIC PUNCH

    MDR report key: 1943580 · Received December 17, 2010

    Report

    Report Number
    1943580
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE AORTIC PUNCH PER USER, THE CARDIAC SURGEON, "IT WILL NOT CUT."====================== HEALTH PROFESSIONAL'S IMPRESSION======================SURGEON SAID IT WOULDN'T CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFECT CUT BULLET-TIP ROTATING AORTIC PUNCH INSTRUMENT, SURGICAL, CARDIOVASCULAR DWS QUEST MEDICAL, INC. * 0371140Y18

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR