BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 385533 · Received March 22, 2002

    Report

    Report Number
    1722040-2002-00002
    Event Type
    Other
    Date Received
    March 22, 2002
    Date of Event
    March 6, 2002
    Report Date
    March 21, 2002
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS RETURNED TO MFR BY THE DISTRIBUTOR STATING THE TIPS OF THE TWO ELECTRODES HAD BROKEN OFF. IT WAS NOT KNOWN IF THIS OCCURRED DURING LAPAROSCOPIC PROCEDURES OR DURING CLEANING OR OTHER HANDLING. IT IS BEING REPORTED BECAUSE IF IT OCCURRED DURING A PROCEDURE THERE MIGHT BE A DELAY TO RETRIEVE THE TIP.

    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 GL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other