BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM SUCTION IRRIGATION ELECTRODE, L-DIAMOND

    MDR report key: 2221918 · Received July 21, 2011

    Report

    Report Number
    1722040-2011-00014
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    PMA / PMN Number
    K100711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT CODE UNAVAILABLE AT THIS TIME. HOSPITAL STATES THE DEVICE WILL BE RETURNED AT THE END OF THE MONTH. IF THIS OCCURS, FURTHER INSPECTION AND EVALUATION WILL TAKE PLACE.

    Description of Event or Problem · 1

    TIP OF SUCTION IRRIGATION ELECTRODE BROKE OFF IN SPD WHILE CLEANING. USED ABOUT 12 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM SUCTION IRRIGATION ELECTRODE, L-DIAMOND ELECTROSURGICAL INSTRUMENT GEI ENCISION, INC. ES3881 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1