BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW CONTROL VALVE UNIT

    MDR report key: 2399315 · Received December 6, 2011

    Report

    Report Number
    2951580-2011-00230
    Event Type
    Malfunction
    Date Received
    December 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    November 7, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR'S REPORT 2951580-2011-00231.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A USER FACILITY IS CURRENTLY USING AN ARTHROCARE FLOW CONTROL VALVE WITH A FLOW CONTROL VALVE UNIT CABLE, AND THAT THE FLOW CONTROL VALVE IS WORKING INTERMITTENTLY. NO PT COMPLICATION OR INJURIES HAVE BEEN REPORTED AS A RESULT OF THIS INCIDENT. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW CONTROL VALVE UNIT ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other