BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM SUCTION IRRIGATION ELECTRODE, SPATULA

    MDR report key: 2141284 · Received May 26, 2011

    Report

    Report Number
    1722040-2011-00004
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 27, 2011
    Manufacturer
    ENCISION
    Product Code
    GEI
    PMA / PMN Number
    K100711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL CONFIRMED THAT THE TIP CASE OFF THE SHAFT OF THE ELECTRODE DURING CLEANING IN SPD. NO PT WAS INVOLVED. THE HOSPITAL ESTIMATED THAT THEY HAD USED THE INSTRUMENT APPROXIMATELY 24 TIMES. THE MAXIMUM NUMBER OF USES, AS NOTED IN THE INSTRUCTIONS FOR USE, IS 25 TIMES. ACTUAL NUMBER OF USES CAN NOT BE DETERMINED WITH CERTAINTY. ENGINEERING ANALYSIS FOUND SMALL HOLES WHERE THE TIP BROKE AWAY AT THE WELD SITES. THE WELD ITSELF HELD AND THE TUBE TORE AWAY DUE TO FATIGUE OR EXCESSIVE FORCE.

    Description of Event or Problem · 1

    TIP BROKE OFF OF SUCTION IRRIGATION ELECTRODE WHILE BEING CLEANED IN STERILE PROCESSING DEPARTMENT. ITEMS ARE CLEANED BY HAND. NO PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM SUCTION IRRIGATION ELECTRODE, SPATULA ELECTROSURGICAL INSTRUMENT GEI ENCISION ES3882 QI

    Patients

    Seq Age Sex Outcome Treatment
    1