BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 383297 · Received March 12, 2002

    Report

    Report Number
    1722040-2002-00001
    Event Type
    Malfunction
    Date Received
    March 12, 2002
    Date of Event
    February 20, 2002
    Report Date
    March 12, 2002
    Manufacturer
    ENCISION INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS RETURNED TO MANUFACTURER BY THE DISTRIBUTOR STATING THE TIP OF THE ELECTRODE WAS DAMAGED AND THE CUSTOMER FEELS IT HAD MANUFACTURING DEFECT. VISUAL INSPECTION SHOWED THE TIP OF THE INSTRUMENT MISSING. THE CUSTOMER HAS NOT RESPONDED TO INQUIRIES TO DETERMINE IF THE TIP CAME OFF DURING A LAPAROSCOPIC PROCEDURE OR WAS DAMAGED IN SOME OTHER WAY. NO INFORMATION WHETHER A PATIENT WAS INVOLVED OR PATIENT STATUS IS AVAILABLE. THE EVENT IS BEING REPORTED BECAUSE IT OCCURRED DURING A PROCEDURE THERE MAY HAVE BEEN 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 GI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other