BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEM FIXED TIP ELECTRODE, 5MM-REUSABLE, CORSON NEEDLE

    MDR report key: 437629 · Received January 10, 2003

    Report

    Report Number
    1722040-2003-00001
    Event Type
    Other
    Date Received
    January 10, 2003
    Date of Event
    December 19, 2002
    Report Date
    January 9, 2003
    Manufacturer
    ENCISION, INC.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE NEEDLE TIP ELECTRODE BROKE OFF IN SURGERY. THE TIP WAS NOT FOUND, THOUGH X-RAY WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM FIXED TIP ELECTRODE, 5MM-REUSABLE, CORSON NEEDLE LAPAROSCOPIC ELECTROSURGICAL DEVICE KNS ENCISION, INC. ES3521-45 HJ

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other