BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1081720 · Received July 18, 2008

    Report

    Report Number
    2210968-2008-00538
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVAL. THE DISPOSABLE HAND PIECE TURNED CLOCKWISE/COUNTER-CLOCKWISE AT ALL SPEED LEVELS. NO GRINDING OR LIGHT FLASHING WAS OBSERVED AND ALIGNMENT OF THE CPC CONNECTOR WAS GOOD. THE UNIT PASSED THE MOTOR STALL TEST AND INTERNAL INSPECTION FOUND NO LOOSE HARDWARE OR ELECTRICAL CONNECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2008. DURING THE PROCEDURE, IT WAS DIFFICULT TO ATTACH THE DISPOSABLE HAND PIECE TO THE MOTOR DRIVE UNIT. THE MOTOR DRIVE UNIT STARTED GRINDING WHEN THE HAND PIECE STOPPED MORCELLATING TISSUE, AND THE LIGHTS ON THE FRONT OF THE UNIT WERE FLASHING. A SECOND DISPOSABLE HAND PIECE WAS OPENED AND CONNECTED, HOWEVER THE HAND PIECE WOULD NOT WORK. THE PROCEDURE WAS COMPLETED VAGINALLY WITH NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPIC MORCELLATOR HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK