BEUDAMED
    FDA Adverse Event Death Summary report: N

    MORCELLATOR

    MDR report key: 4435330 · Received January 16, 2015

    Report

    Report Number
    2951238-2015-00014
    Event Type
    Death
    Date Received
    January 16, 2015
    Date of Event
    September 16, 2011
    Report Date
    January 8, 2015
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE RETURNED TO OLYMPUS FOR EVAL, AND SINCE THERE WAS NO SPECIFIC MODEL OR LOT NUMBER PROVIDED FOR DEVICE, OLYMPUS CANNOT CONCLUSIVELY DETERMINE IF THE DEVICE IS AN OLYMPUS' MANUFACTURED DEVICE OR NOT. OLYMPUS WILL CONTINUE TO INVESTIGATE THIS REPORT, AND IF ADD'L SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. THE FILING OF THIS REPORT IS NOT AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A PT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY USING AN UNIDENTIFIED MORCELLATOR IN 2011. THE PT WAS LATER DIAGNOSED OF CANCEROUS ABDOMINAL TUMOR AND UNDERWENT AGGRESSIVE TREATMENT IN 2012. THE PT UNDERWENT A BILATERAL SALPINGECTOMY, OOPHORECTOMY AND RADICAL EXCISION OF PELVIC TUMOR IN (B)(6) 2012. THE PT WAS REPORTEDLY EXPIRED DUE TO A METASTATIC CERVICAL CANCER. OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENT BUT WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40707 MORCELLATOR MORCELLATOR HET GYRUS ACMI, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death