BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROCISE MAX

    MDR report key: 3795699 · Received April 24, 2014

    Report

    Report Number
    3006524618-2014-00124
    Event Type
    Death
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT DEATH OCCURRED DURING A MULTI SCOPE PROCEDURE, WHICH WAS TO INCLUDE AN ENT PORTION USING A PROCISE MAX WAND. THE DEATH OCCURRED PRIOR TO THE ENT PORTION OF THE PROCEDURE, SO THE PROCISE MAX WAND THAT WAS PREPPED FOR THIS PROCEDURE WAS NEVER USED, NOR DID IT COME IN CONTACT WITH THE PT. NO FURTHER DETAILS WERE PROVIDED TO ARTHROCARE, AS NO ARTHROCARE DEVICES CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248832 PROCISE MAX ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION 1048861

    Patients

    Seq Age Sex Outcome Treatment
    1 Death