BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 716784 · Received May 15, 2006

    Report

    Report Number
    1722040-2006-00002
    Event Type
    Other
    Date Received
    May 15, 2006
    Date of Event
    April 28, 2006
    Report Date
    May 10, 2006
    Manufacturer
    ENCISION INC.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER NOTICED TIP OF CORSON NEEDLE FIXED TIP ELECTRODE WAS BROKEN OFF, BUT DID NOT KNOW IF IT OCCURED DURING A PROCEDURE OR DURING OTHER HANDLING.

    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. ES3523B FK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other