BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3257077 · Received July 31, 2013

    Report

    Report Number
    9680837-2013-00020
    Event Type
    Malfunction
    Date Received
    July 31, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S
    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

    CONCOMITANT MEDICAL PRODUCTS: CEV669B (LOT # 121103), MANUFACTURING DATE: NOVEMBER 2012. CEV669B (LOT #110901), MANUFACTURING DATE: SEPTEMBER 2011. CEV6795B (LOT # 06/05), MANUFACTURING DATE: JUNE 2005. CEV6795B (LOT # 110801), MANUFACTURING DATE: AUGUST 2011. CEV6795B (LOT # 120506), MANUFACTURING DATE: MAY 2012. CEV634-1A (LOT # 120530), MANUFACTURING DATE: MAY 2012. CEV634-1A (LOT # 121018), MANUFACTURING DATE: OCTOBER 2012. CEV634-1A (LOT # 110806), MANUFACTURING DATE: AUGUST 2011. (B)(4). THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC¿S MXI FACILITY IN FRANCE. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED NINE INSTRUMENTS TO MXI FOR EVALUATION. THERE WAS NO ALLEGATION OF PATIENT INJURY. EVALUATION RESULTS ARE BELOW. THREE HANDLES (CEV669B) WERE EVALUATED. THE REPAIR TECH DETERMINED THE BLACK PLASTIC PIECE (INSULATOR) IS BURNT AT THE CONNECTION LEVEL. THIS WAS DUE TO AN ELECTRICAL ARCH CAUSE FROM THE PRESENCE OF HUMIDITY IN THE CONNECTION POINT. IT WAS FURTHER DISCOVERED THE CABLE HAD BLOOD, TISSUE, AND HAD NOT BEEN PROPERLY DRIED. THREE TUBES (CEV6795B) WERE EVALUATED. REPAIR DETERMINED THE RETURNED INSTRUMENTS FUNCTIONED AS DESIGNED AND CONFORMED TO MANUFACTURING SPECIFICATIONS. THREE INSERTS (CEV634-1A) WERE EVALUATED. EVALUATION FOR THE INSERT (LOT # 120530) INDICATED THAT THE TUBE 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. EVALUATION FOR THE INSERT (LOT #121018) DETERMINED THAT THE COATING (INSULATION) WAS DAMAGED; MOST LIKELY DURING USE REPROCESSING. REPAIR INDICATED INSERT (LOT # 110806) HAD A SHORT-CIRCUIT AND IS MOST LIKELY THE CONSEQUENCE OF THE ELECTRICAL ARC HIGHLIGHTED ON THE HANDLES RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357010 HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S CEV669B 06/05

    Patients

    Seq Age Sex Outcome Treatment
    1