BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM]

    MDR report key: 3299117 · Received August 20, 2013

    Report

    Report Number
    9680837-2013-00031
    Event Type
    Malfunction
    Date Received
    August 20, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CEV636-1A (LOT # 120704) - MANUFACTURING DATE: JULY 2012. (B)(4). TWO DEVICES WERE RETURNED TO MXI FOR EVALUATION. EVALUATION RESULTS ARE BELOW. ANALYSIS FOR DEVICE (HANDLE CEV669B DIA 5MM ANG BIPOLAR) INDICATED THAT THE BLACK PLASTIC AT THE CONNECTION LEVEL PIECE IS BURNT. THE BURNT PLASTIC IS PROBABLY THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC DUE TO THE PRESENCE OF HUMIDITY (BLOOD/TISSUES/CABLE NOT DRIED) IN THE CONNECTION ZONE. THE ELECTRODE TUBE ON THE DEVICE (BIPOLAR INSERT CEV636-1A 350MM GAYET) PRESENTS A CRACK AND A BLISTER. THE FORMATION OF A BLISTER IS DUE TO THE PRESSURE OF THE GLUE ON A PRE-EXISTING CRACK ON THE TUBE DURING STERILIZATION CYCLES. THE TUBE IS BENT AND THE TIP AT THE CONNECTION LEVEL IS UN-WELDED. THE DAMAGE (BENT <(>&<)> UN-WELDED TIP) IS MOST LIKELY CAUSED BY EXCESSIVE CONSTRAINT APPLIED ON THE DEVICE. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC¿S MXI FACILITY IN (B)(4). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. MXI CAPA (B)(4) WAS OPENED TO ADDRESS THESE ISSUES. (B)(4).

    Description of Event or Problem · 1

    TWO DEVICES (CEV669B <(>&<)> CEV636-1A) WERE RETURNED TO MXI FOR SERVICE <(>&<)> REPAIR. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401833 HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S CEV669B 120605

    Patients

    Seq Age Sex Outcome Treatment
    1