BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM SUCTION IRRIGATION ELECTRODE, L-HOOK

    MDR report key: 2221926 · Received July 21, 2011

    Report

    Report Number
    1722040-2011-00012
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATING ROOM DIRECTOR HAS BEEN CONTACTED BY LETTER, AFTER ATTEMPTS BY PHONE, TO CONFIRM WHERE THE TIP FELL OFF, AND TO PROVIDE PATIENT INFORMATION IF APPLICABLE. INITIAL REPORTER DID NOT HAVE THIS INFORMATION.

    Description of Event or Problem · 1

    HOSPITAL REPORTED TIP OF SUCTION IRRIGATION ELECTRODE BROKE OFF IN USE. INFORMATION IS NOT AVAILABLE TO CONFIRM WHETHER IT CAME OFF IN THE PATIENT OR DURING CLEANING. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention