BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII FIOS 12X150MM Z-THREAD

    MDR report key: 3243222 · Received July 19, 2013

    Report

    Report Number
    2027111-2013-00277
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 15, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A F/U REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    LAPAROSCOPY - "DURING INTRODUCTION OF A CLIP INSIDE THE TROCAR A PIECE OF THE VALVE SEAL FOR BROKEN AND FELL INSIDE THE PT. THE PIECE WAS REMOVED SUCCESSFULLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338074 KII FIOS 12X150MM Z-THREAD NONE GCJ APPLIED MEDICAL CTF71 1187874

    Patients

    Seq Age Sex Outcome Treatment
    1