BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM SUCTION/IRRIGATION ELECTRODE - L-HOOK

    MDR report key: 2466833 · Received February 16, 2012

    Report

    Report Number
    1722040-2011-00027
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 20, 2012
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    PMA / PMN Number
    K100711
    Removal / Correction Number
    Z-3095-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PROBLEM KNOWN AND BEING ADDRESSED BETWEEN THE MANUFACTURER AND FDA. DEVICE IS CURRENTLY UNDER ACTIVE RECALL (Z-3095-2011) FOR THIS PROBLEM. NO FURTHER INVESTIGATION OF THIS INSTANCE TO BE PERFORMED.

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE ENCISION LAPAROSCOPIC HOOK BROKE OFF FROM THE SLEEVE DURING THE PROCEDURE. THE HOOK WAS RETRIEVED WITHOUT COMPLICATIONS FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention