BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIGEN RADIOFREQUENCY GENERATOR

    MDR report key: 2946357 · Received February 6, 2013

    Report

    Report Number
    0001811755-2013-00187
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION. IT WAS FOUND THAT THE TOUCH SCREEN WAS DAMAGED AND NEEDED REPLACED. AFTER THE TOUCH SCREEN WAS REPLACED THE UNIT OPERATED NORMALLY AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING AND WAS SHOWING AN ERROR MESSAGE DURING A PROCEDURE. A BACK-UP WAS RETRIEVED AND THE CASE WAS COMPLETED. THERE WAS A DELAY OF 30 MINUTES WHILE THE BACK-UP WAS OBTAINED. THE PATIENT HAD RECEIVED LIGHT SEDATION DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING AND WAS SHOWING AN ERROR MESSAGE DURING A PROCEDURE. A BACK-UP WAS RETRIEVED AND THE CASE WAS COMPLETED. THERE WAS A DELAY OF 30 MINUTES WHILE THE BACK-UP WAS OBTAINED. THE PATIENT HAD RECEIVED LIGHT SEDATION DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50263 MULTIGEN RADIOFREQUENCY GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1