BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIGEN RADIOFREQUENCY GENERATOR

    MDR report key: 3923031 · Received July 9, 2014

    Report

    Report Number
    0001811755-2014-02440
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE MAINTENANCE WAS PERFORMED ON THE DEVICE AND IT WAS RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN RF ABLATION THE MULTIGEN RADIOFREQUENCY GENERATOR WAS INDICATING A SYSTEM ERROR. AS A RESULT, THE CASE HAD TO BE RESCHEDULED. IT WAS REPORTED THAT THE PATIENT HAD ALREADY RECEIVED ANESTHESIA PRIOR TO THE CASE BEING CANCELED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN RF ALBAION THE MULTIGEN RADIOFREQUENCY GENERATOR WAS INDICATING A SYSTEM ERROR. AS A RESULT, THE CASE HAD TO BE RESCHEDULED. IT WAS REPORTED THAT THE PATIENT HAD ALREADY RECEIVED ANESTHESIA PRIOR TO THE CASE BEING CANCELED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399322 MULTIGEN RADIOFREQUENCY GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1