BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT ONLY F/MODULAR MONOPOL. ELECTR

    MDR report key: 3960921 · Received May 23, 2014

    Report

    Report Number
    2916714-2014-00381
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    March 3, 2014
    Report Date
    May 23, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON MAY 22, 2014. MANUFACTURING SITE EVALUATION: THE ELECTRODE IS POLLUTED WITH CARBONIZED TISSUE. THIS LEADS TO LEAKAGE OF CURRENT WHICH BURNS NEIGHBORING TISSUE. FAILURE IS USER RELATED. THERE ARE NO HINTS FOR MATERIAL OR PRODUCT DEVIATIONS. NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE HEAD WAS BURNED BY THE TRANSMISSION OF ENERGY WITH THE SPATULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307393 SHAFT ONLY F/MODULAR MONOPOL. ELECTR ENDOSCOPIC DEVICE GEI AESCULAP AG & CO. KG GK370P

    Patients

    Seq Age Sex Outcome Treatment
    1