BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR INSERT CEV634-1A 350MM MOUIEL

    MDR report key: 3786569 · Received May 2, 2014

    Report

    Report Number
    9680837-2014-00038
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 16, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: CEV669B: HANDLE CEV669B DIA CEV669B 5MM ANG BIPOLAR, LOT 140106 510K: K993655 MANUFACTURED 1/2014 CEV6795B: TUBE CEV6795B DIA 5MM 350MM, LOT 140202 510K: K993655, MANUFACTURED 2/2014. (B)(4): PRODUCT EVALUATION: ANALYSIS ON THE REPORTED DEVICE, THE BIPOLAR INSERT (CEV634-1A), FOUND THAT AN IMPACT IS OBSERVABLE ON THE COATING, ON THE DISTAL PART OF THE INSTRUMENT, NEXT TO THE JAW. THE ELECTRICAL TESTS FAILED BECAUSE OF THIS IMPACT. CONSIDERING THE ASPECT OF THE IMPACT, THE INSTRUMENT IS VERY LIKELY TO HAVE TAKEN A SHOCK WITH ANOTHER SHARP INSTRUMENT. ANALYSIS OF CONCOMITANT DEVICES: ANALYSIS OF THE BIPOLAR HANDLE (CEV669B) FOUND THAT THE HANDLE CAME BACK DISASSEMBLED. THE CENTRAL PEEK PART IS MISSING. HOWEVER, THIS PART OF THE INSTRUMENT IS NOT IN CONTACT WITH THE PATIENT AND THE RISK OF FRAGMENT IN THE SURGICAL AREA IS VERY LOW. THE HANDLE WAS IN ALL LIKELIHOOD DISASSEMBLED DURING THE REPROCESSING STEPS, DESPITE THE INSTRUCTIONS FOR USE RECOMMENDATIONS. ANALYSIS OF THE TUBE (CEV6795B) FOUND NO ISSUE HIGHLIGHTED. INSTRUMENT CONFORMS TO MANUFACTURING SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A ¿BROKEN ELECTRIC CONNECTOR¿. THERE WAS NO REPORTED PATIENT IMPACT. ANALYSIS FOUND THAT AN IMPACT IS OBSERVABLE ON THE COATING, ON THE DISTAL PART OF THE INSTRUMENT, NEXT TO THE JAW. THE ELECTRICAL TESTS FAILED BECAUSE OF THIS IMPACT. IT HAS BEEN CONFIRMED THAT THE ¿COATING¿ IS REFERRING TO THE INSULATION, AND THERE IS A BREACH IN THE INSULATION. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264930 BIPOLAR INSERT CEV634-1A 350MM MOUIEL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV634-1A 140207

    Patients

    Seq Age Sex Outcome Treatment
    1