BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ LAPAROSCOPE

    MDR report key: 1002153 · Received January 22, 2008

    Report

    Report Number
    1002153
    Event Type
    Malfunction
    Date Received
    January 22, 2008
    Date of Event
    January 4, 2008
    Report Date
    January 22, 2008
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE TIP OF THE NEEDLE HOLDER BROKE OFF INSIDE THE PATIENT. THE X-RAY WAS CALLED TO HELP LOCATE THE TIP. IT WAS FOUND AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LAPAROSCOPE NEEDLE HOLDER GCJ KARL STORZ ENDOSCOPY-AMERICA, INC. 26167FN GH 2

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR