BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUCTION IRRIGATION ELECTRODE, SPATULA, BARD DAVOL TRUMPET

    MDR report key: 482996 · Received September 3, 2003

    Report

    Report Number
    1722040-2003-00011
    Event Type
    Other
    Date Received
    September 3, 2003
    Date of Event
    August 8, 2003
    Report Date
    September 2, 2003
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTED THE TIP CAME OFF THE SUCTION IRRIGATION ELECTRODE DURING A LAP. CHOLE, PROCEDURE, BUT WAS RETRIEVED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION IRRIGATION ELECTRODE, SPATULA, BARD DAVOL TRUMPET LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES3602B HL

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other