BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR HANDLE DIA 5MM ERG [MXI/XOM]

    MDR report key: 3299179 · Received August 20, 2013

    Report

    Report Number
    9680837-2013-00033
    Event Type
    Malfunction
    Date Received
    August 20, 2013
    Report Date
    February 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CEV669BG (LOT # 120101; QUANTITY 1) - MANUFACTURING DATE: JANUARY 2012. CEV669BG (LOT # 111001; QUANTITY 1) - MANUFACTURING DATE: OCTOBER 2011. (B)(4). THREE DEVICES (BIPOLAR HANDLE CEV669BG DIA 5MM ERG) WERE RETURNED FOR ANALYSIS. ANALYSIS INDICATED THAT DURING ASSEMBLING, THE ELECTRODES DO NOT STAY BLOCKED ON THE HANDLE. THE PLASTIC PIECES AT THE CONNECTION LEVEL HAD SOME RESIDUES OF BURNT PLASTIC. THE DIFFICULTIES EXPERIENCED WITH FITTING ARE DUE TO THE PRESENCE OF BURNT PLASTIC RESIDUES AT THE PIN CONNECTION AREA. THESE RESIDUES ARE PROBABLY THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC IN THE CONNECTION ZONE FOLLOWING THE PRESENCE OF HUMIDITY, BLOOD OR A DAMAGED CABLE DURING COAGULATION. 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

    IT WAS REPORTED THAT THE HANDLE DOES NOT FIT WITH TIP OF BIPOLAR FORCEPS. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402945 BIPOLAR HANDLE DIA 5MM ERG [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S CEV669BG 120101

    Patients

    Seq Age Sex Outcome Treatment
    1