BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF MULTIGEN

    MDR report key: 1842206 · Received August 24, 2010

    Report

    Report Number
    1811755-2010-01016
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR INVESTIGATION, AND THE FAILURE COULD NOT BE DUPLICATED. MAINTENANCE WAS PERFORMED ACCORDING TO THE MOST RECENT REVISION AND THE PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    DURING AN RF PROCEDURE, THE DEVICE DISPLAYED AN ERROR MESSAGE. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND BACKUP EQUIPMENT WAS NOT AVAILABLE. THE PATIENT HAD ALREADY BEEN GIVEN A LOCAL ANESTHETIC WHEN IT WAS DECIDED TO CANCEL THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF MULTIGEN GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK