BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON HASSON TROCAR

    MDR report key: 2250754 · Received September 2, 2011

    Report

    Report Number
    2250754
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 1, 2011
    Manufacturer
    STRYKER
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    A 12 MM HASSON TROCAR BROKE INTO PIECES WHILE BEING UTILIZED IN THE PATIENT. ALL PIECES WERE ACCOUNTED FOR AND REMOVED FROM FIELD. (THIS WAS A REPROCESSED DEVICE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON HASSON TROCAR SURGICAL DEVICE 12MM HASSON TROCAR GCJ STRYKER H12LP *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR