BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKTRAFUSE HF GENERATOR BIPOLAR

    MDR report key: 5474400 · Received March 2, 2016

    Report

    Report Number
    2916714-2016-00147
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Date of Event
    February 1, 2016
    Report Date
    March 2, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K130596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: ONE GN200 SERIAL NUMBER (B)(4) BATCH NUMBER (B)(4) MANUFACTURE DATE 04/21/2015 RECEIVED FOR EVALUATION. THE DEVICE WAS IN GOOD COSMETIC CONDITION ON ITS EXTERNAL SURFACE. FUNCTIONAL AND PARAMETRIC ANALYSIS WAS COMPLETED ON THE UNIT. UPON OPENING THE HOUSING OF THE UNIT, IT WAS NOTICED THAT THERE WAS A BURST CAPACITOR ON THE PCB. THE BURST LOCATION WAS IN THE CENTER BETWEEN THE TERMINALS. MAGNIFICATION SHOWED THE DAMAGED MICA-DIELECTRIC (BURST MICA-WASHERS). BATCH HISTORY REVIEW INDICATES THIS IS THE ONLY ITEM OF THIS BATCH. EOL TESTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE BREAKDOWN OF THE CAPACITOR MAY HAVE RESULTED FROM: INITIAL DAMAGE BY ASSEMBLING / SOLDERING OF THE BOARD (MOST LIKELY). ELECTRICAL OVERSTRESS (EOS, UNLIKELY). DEFECT OF MANUFACTURING OF THE CAPACITOR (DAMAGE / CRACK OF THE MICA- WASHERS,VERY UNLIKELY). BLEMISHES IN THE MICA - WASHERS (IMPERFECTION OF THE MUSCOVITE STRUCTURE, VERY UNLIKELY). THE MOST LIKELY ROOT CAUSE FOR THE BREAKDOWN OF THE CAPACITOR IS AN INITIAL DAMAGE DURING THT- PLACEMENT PROCESS (BENDING CRACKS AT THE TERMINALS ) OR SOLDERING (HEAT CRACKS CAUSED THROUGH INCORRECT GRADIENT PREHEATING / COOLING). SUCH A CRACK WILL NOT IMMEDIATELY LEAD TO A FAULT. THE FAULT WILL OCCUR AFTER A COUPLE OF OPERATING HOURS, A ION- MIGRATION THROUGH THE CRACK IN THE DIELECTRIC LEADS TO A CONDUCTION BETWEEN THE ELECTRODES OF THE CAP. UNDER CERTAIN CIRCUMSTANCES SUCH A DEFECT CAN NOT BE DETECTED IN THE EOL- TEST. EOS CAN BE RULED OUT, BECAUSE THE ELECTRIC STRENGTH OF THE CAP IS SPECIFIED WITH 500V DC. ADDITIONALLY, MICA HAS A VERY LOW LOSS ANGLE, SO AN OVERSTRESS CAUSED BY HEATING UP DURING OPERATION CAN BE RULED OUT. A DEFECT DURING PRODUCTION OF THE CAP, RESPECTIVELY BLEMISHES IN THE DIELECTRIC BASE MATERIAL, IS VERY UNLIKELY BECAUSE OF THE RIGOROUS 100% TESTING PROCEDURE OF CAPS. CORRECTIVE / PREVENTIVE ACTION: NOT APPLICABLE.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). SURGEON NOTICED THE SMELL OF CHARRED ELECTRICS WHEN THE GENERATOR WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129977 LEKTRAFUSE HF GENERATOR BIPOLAR GENERATOR GEI AESCULAP AG GN200 52127030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other