BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KII 12X100 Z-THR OPT SEP SYS

    MDR report key: 3181375 · Received June 14, 2013

    Report

    Report Number
    2027111-2013-00219
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 7, 2013
    Report Date
    June 10, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

    Description of Event or Problem · 1

    LAPAROSCOPIC LEFT HEMICOLECTOMY - "TROCAR HAVE ALLOWED THE DEVELOPMENT OF AN IMPORTANT AND EXTENSIVE SUBCUTANEOUS EMPHYSEMA THAT PROGRESSIVELY REACHED PATIENT NECK. THIS SITUATION TOOK TO AN EXCESSIVE REABSORPTION OF CO2 WITH CONSIDERABLE DIFFICULTY BY ANESTHESIOLOGISTS TO MAINTAIN AN ADEQUATE VENTILATION. NEED TO TRANSFER PATIENT IN INTENSIVE CARE AT THE END OF INTERVENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271989 KII 12X100 Z-THR OPT SEP SYS NONE GCJ APPLIED MEDICAL CTR73 1188716

    Patients

    Seq Age Sex Outcome Treatment
    1 Other