BEUDAMED
    FDA Adverse Event Other Summary report: N

    DOLPHIN NOSE GRASPER INSERT

    MDR report key: 514195 · Received February 27, 2004

    Report

    Report Number
    1722040-2004-00001
    Event Type
    Other
    Date Received
    February 27, 2004
    Date of Event
    February 9, 2004
    Report Date
    February 26, 2004
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTED THE JAWS OF THE GRASPER CAME OFF THE SHAFT INSIDE THE PT DURING A LAPAROSCOPIC GALLBLADDER PROCEDURE. ALL THE PIECES WERE RETRIEVED FROM THE PT AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOLPHIN NOSE GRASPER INSERT LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES0511 HA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other