BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEVELED MARYLAND DISSECTOR, TAPERED

    MDR report key: 1850151 · Received July 13, 2010

    Report

    Report Number
    1722040-2010-00006
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    June 10, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ENCISION INC
    Product Code
    GEI
    PMA / PMN Number
    K912780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DETERMINATION COULD BE MADE OF THE FAILURE MODE OR CAUSE, BECAUSE, THE DEVICE WAS NOT RETURNED BY THE CUSTOMER. IT CANNOT BE DETERMINED IF THE DAMAGE COULD HAVE OCCURRED IN SURGERY. HOWEVER, NO OTHER PROBLEMS FOR THIS CATALOG NUMBER HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    HOSPITAL REPORTED, TIP WAS BROKEN IN SPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEVELED MARYLAND DISSECTOR, TAPERED LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION INC ES0556 GK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA