BEUDAMED
    FDA Adverse Event Death Summary report: N

    KII 5X100 FIOS Z-THR

    MDR report key: 3867323 · Received June 11, 2014

    Report

    Report Number
    2027111-2014-00249
    Event Type
    Death
    Date Received
    June 11, 2014
    Date of Event
    April 24, 2014
    Report Date
    June 11, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNITS WERE RETURNED FOR EVALUATION. UPON INSPECTION OF THE TROCARS, ENGINEERING FOUND NO VISIBLE DAMAGES OR DEFECTS. THE UNITS WERE LEAK TESTED TO TEST THE INTEGRITY OF THE SEAL AND NO LEAKAGE WAS NOTED WITH OR WITHOUT A PROBE INSERTED. UPON INSPECTION OF THE INSUFFLATION NEEDLE, THE UNIT DEPRESSED WITH NORMAL FORCE AND FUNCTIONED AS DESIGNED. ALL RETURNED UNITS MET CURRENT DESIGN SPECIFICATIONS. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE INCIDENT AND RELATED PRODUCTS. AT THIS TIME, APPLIED MEDICAL IS UNABLE TO DETERMINE THE CAUSE OF THE CARDIAC ARREST OR CONFIRM THAT A PRODUCT MALFUNCTION OCCURRED. THIS DOCUMENT REPRESENTS OUR INITIAL/ FINAL REPORT.

    Description of Event or Problem · 1

    LAP CHOLE: "PLACES THE TROCARS, INSUFLATED AND PATIENT WENT INTO CARDIAC ARREST." PATIENT STATUS: "EXPIRED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344199 KII 5X100 FIOS Z-THR LAPAROSCOPIC TROCAR, CODE:GCJ GCJ APPLIED MEDICAL CTF03 1207884

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CTF73/1209938, C2201/1211605, CTS02/1215188