BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 826623 · Received February 9, 2007

    Report

    Report Number
    2210968-2007-00258
    Event Type
    Injury
    Date Received
    February 9, 2007
    Date of Event
    February 9, 2007
    Report Date
    February 9, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    GCJ
    PMA / PMN Number
    k061050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN A THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCHES 2110968-2007-00256, 2210968-2007-00257, AND 2210968-2007-00259. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO REMOVE A LARGE 20-WEEK SIZED FIBROID. THE FIRST DISPOSABLE HANDPIECE USED CUT INITIALLY, BUT AFTER APPROXIMATELY TWO OR THREE CUTS THE TISSUE STRIPS JAMMED THE HANDPIECE. A DIFFERENT TYPE OF DISPOSABLE HANDPIECE WAS TRIED AND AFTER APPROXIMATELY TEN MINUTES OF USAGE THE DEVICE STOPPED CUTTING. THREE MORE DISPOSABLE HANDPIECES, WHICH WERE OF THE SAME TYPE AS THE INITIAL HANDPIECE USED, WERE ATTEMPTED. AFTER TWO TO THREE CUTS, THE TISSUE STRIPS JAMMED THE HANDPIECES. A LARGER INCISION WAS MADE TO REMOVE THE FIBROID MANUALLY AND COMPLETE THE PROCEDURE. THE SURGERY TIME WAS EXTENDED OVER FIVE HOURS. THE PATIENT REMAINED HOSPITALIZED FOR THREE DAYS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC GCJ ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R