BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM FIXED TIP ELECTRODE, 5MM REUSABLE L-DIAMOND

    MDR report key: 736669 · Received June 24, 2005

    Report

    Report Number
    1722040-2005-00008
    Event Type
    Malfunction
    Date Received
    June 24, 2005
    Date of Event
    May 24, 2005
    Report Date
    June 23, 2005
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN REMOVING THE ELECTRODE, DOCTOR CAUGHT THE TIP ON THE TROCAR AND IT CAME OFF THE SHAFT OF THE INSTRUMENT. TIP WAS NOT RETRIEVED FROM THE PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM FIXED TIP ELECTRODE, 5MM REUSABLE L-DIAMOND LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES3511B GIA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other