BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF MULTIGEN

    MDR report key: 2425143 · Received January 17, 2012

    Report

    Report Number
    1811755-2012-00192
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    December 20, 2011
    Report Date
    December 20, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. ONCE IT IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE UNIT WAS NOT REGISTERING IMPEDENCE ON THE SCREEN. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR THE NEXT DAY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF MULTIGEN GXD STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK