BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIGEN RADIOFREQUENCY GENERATOR

    MDR report key: 2507058 · Received March 23, 2012

    Report

    Report Number
    1811755-2012-01083
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 24, 2012
    Report Date
    February 24, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS AN ISSUE WITH THE GROUNDING PAD. THE PROCEDURE HAD TO BE CANCELLED AND RESCHEDULED FOR A LATER DATE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIGEN RADIOFREQUENCY GENERATOR GXD STRYKER INSTRUMENTS KALAMAZOO LES5029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK