BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 724434 · Received June 8, 2006

    Report

    Report Number
    2210968-2006-00416
    Event Type
    Injury
    Date Received
    June 8, 2006
    Report Date
    May 10, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H-6 67: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. PMA 510K NUMBER IS: K993801

    Description of Event or Problem · 1

    DURING GYNECOLOGICAL PROCEDURE, THE DEVICE GOT HOT TO THE TOUCH AFTER FIVE TO TEN MINUTES OF USE. THE UNIT BECAME NON-RESPONSIVE AND THE POWER SETTINGS COULD NOT BE ADJUSTED. THE PROCEDURE WAS CONVERTED TO LAPAROTOMY. THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention