BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEM FIXED TIP ELECTRODE, 5 MM REUSABLE - L -DIAMOND

    MDR report key: 485404 · Received September 15, 2003

    Report

    Report Number
    1722040-2003-00013
    Event Type
    Other
    Date Received
    September 15, 2003
    Date of Event
    July 17, 2003
    Report Date
    September 15, 2003
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THE TIP CAME OFF THE INSTRUMENT USED BY THE SURGEON, WHILE INSIDE THE PATIENT. THE DOCTOR WITNESSED THE PROBLEM AND WAS ABLE TO RETRIEVE IMMEDIATELY. NO HARM TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other