BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]

    MDR report key: 3476027 · Received November 19, 2013

    Report

    Report Number
    9680837-2013-00497
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    October 30, 2013
    Report Date
    October 31, 2013
    Manufacturer
    XOMED MICROFRANCE MANUFACTURING
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: CONCOMITANT DEVICES: CEV649-5B, TUBE CEV649-5B DIA 5MM 350MM, LOT 130904. MANUFACTURED SEPTEMBER 1, 2013. CEV10195R, HANDLE CEV10195R DIA 5MM ANG W/ RATCHET, LOT 130908 MANUFACTURED SEPTEMBER 1, 2013. CEV625-1, INSERT CEV625-1 FENESTRATED 350MM, LOT 130906 MANUFACTURED SEPTEMBER 1, 2013. (B)(4). PRODUCT EVALUATION: PRODUCT ANALYSIS FOR CEV649-5B FOUND THAT THE TUBES ARE BENT AND SHOW IMPACTS ON THEIR INSULATION. A LARGE PART OF INSULATION IS MISSING ON ONE OF THE TUBES AND HAS NOT BEEN RETURNED. THE SURGEON HAS HOWEVER CONFIRMED THAT THE FRAGMENT HAS BEEN RECOVERED WITHOUT ANY PATIENT IMPACT. CONSIDERING THE EXTENT OF THE DAMAGES HIGHLIGHTED, IT IS VERY LIKELY THAT THE INSTRUMENTS HAVE SUFFERED EXCESSIVE CONSTRAINT DURING USE OR REPROCESSING. PRODUCT ANALYSIS FOR CEV10195R FOUND THAT THERE WAS NO ISSUE HIGHLIGHTED. INSTRUMENTS CONFORM TO MANUFACTURING SPECIFICATIONS. THE INSERTS, CEV625-1, ARE VERY BENT AND CANNOT BE INSERTED IN A TUBE. THESE INSERTS WENT UNDER EXCESSIVE CONSTRAINTS DURING THEIR USE AND/OR DURING THE REPROCESSING STEPS. RESULTS: STRESS PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THESE DEVICES WERE RETURNED FOR REPAIR. CUSTOMER STATED THAT THIS ¿IS THE FIRST TIME I GET BACK FORCEPS IN SUCH BAD SHAPE AFTER 15 DAYS OF USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600332 TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MANUFACTURING CEV649-5B 130903

    Patients

    Seq Age Sex Outcome Treatment
    1