BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1012996 · Received February 28, 2008

    Report

    Report Number
    1012996
    Event Type
    Malfunction
    Date Received
    February 28, 2008
    Date of Event
    January 4, 2008
    Report Date
    February 28, 2008
    Manufacturer
    PILLING SURGICAL, A TELEFLEX COMPANY
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE AORTIC PUNCH USED IN THIS PROCEDURE RETAINED TISSUE IN THE CYLINDER INSTEAD OF ALLOWING IT TO BE DISCARDED. WHEN THE DOCTOR USED THE PUNCH A SECOND TIME, THE TISSUE WAS RELEASED AND PARTIALLY CAUGHT ON THE EDGE OF THE BLADE. THE DEVICE WAS IMMEDIATELY REPLACED WITH A NEW PUNCH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * AORTIC PUNCH DWS PILLING SURGICAL, A TELEFLEX COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR