BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM SUCTION IRRIGATION ELECTRODE, L-HOOK

    MDR report key: 2229190 · Received August 24, 2011

    Report

    Report Number
    1722040-2011-00020
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    PMA / PMN Number
    K100711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTED THE TIP OF HE SUCTION IRRIGATION ELECTRODE BROKE OFF DURING CLEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM SUCTION IRRIGATION ELECTRODE, L-HOOK ELECTROSURGICAL INSTRUMENT GEI ENCISION, INC. ES3883 RA

    Patients

    Seq Age Sex Outcome Treatment
    1