BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MORCELLEX UNKNOWN PRODUCT

    MDR report key: 5123120 · Received October 2, 2015

    Report

    Report Number
    2210968-2015-14380
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    February 17, 2010
    Report Date
    September 30, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 4/6/2016.

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE DEVICE INFORMATION FOR USE UNDER PRECAUTIONS STATES" CAUTION: THE USE OF A LAPAROSCOPIC TISSUE EXTRACTION BAG IS RECOMMENDED FOR THE MORCELLATION OF MALIGNANT TISSUE OR TISSUE SUSPECTED OF BEING MALIGNANT AND FOR TISSUE THAT THE PHYSICIAN CONSIDERS TO BE POTENTIALLY HARMFUL WHEN DISSEMINATED IN A BODY CAVITY. AS MORCELLATION MAY AFFECT ENDOMETRIAL PATHOLOGIC EXAMINATION, PREOPERATIVE EVALUATION OF THE ENDOMETRIUM SHOULD BE CONSIDERED. SHOULD MALIGNANCY BE IDENTIFIED, USE OF THE GYNECARE MORCELLEX¿ TISSUE MORCELLATOR MAY LEAD TO DISSEMINATION OF MALIGNANT TISSUE. IT IS UNKNOWN IF THE ACTUAL DEVICE USED IN THIS PATIENT PROCEDURE WAS IN FACT AN ETHICON MORCELLATOR. THE EVENT INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY FOR ADNEXAL MASS, POSSIBLE OVARIAN CYST, PELVIC PAIN, AND UTERINE FIBROIDS ON (B)(6) 2010 AND A MORCELLATOR WAS UTILIZED TO CUT, SHRED AND REMOVE MUCH OF THE UTERUS. IT WAS DETERMINED THAT LEIOMYOSARCOMA CANCER WAS PRESENT IN THE TISSUE REMOVED. THE PATIENT UNDERWENT SEVERAL ADDITIONAL PROCEDURES RELATED TO THE DISSEMINATED CANCER AND FURTHER SPREAD, INCLUDING A COMPLETE HYSTERECTOMY AND TUMOR REMOVAL. THE PATIENT UNDERWENT AGGRESSIVE RADIATION AND CHEMOTHERAPY TREATMENTS IN AN EFFORT TO TREAT THE UPSTAGED CANCER. DESPITE THAT TREATMENT, THE CANCER CONTINUED TO SPREAD. AS A RESULT, THE PATIENT EXPERIENCED FATIGUE, PAIN, INFLAMMATION, SWELLING, INSOMNIA, AND GASTROINTESTINAL DISTRESS. IT WAS REPORT THAT THE PATIENT DIED ON (B)(6) 2015. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653532 GYNECARE MORCELLEX UNKNOWN PRODUCT LAPARSCOPIC, GYNECOLOGIC HET ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| R