BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 8507520 · Received April 12, 2019

    Report

    Report Number
    2951238-2019-00737
    Event Type
    Death
    Date Received
    April 12, 2019
    Report Date
    October 6, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION TO MDR# 2951238-2019-00737. THE PRODUCT WAS NOT RETURNED AND THE MODEL NUMBER COULD NOT BE CONFIRMED. 962000PK IS A PLACEHOLDER MODEL NUMBER AS IT IS THE ONLY MORCELLATOR PRODUCT THAT OLYMPUS HAS MANUFACTURED AT THE TIME OF THE LEGAL FILE REPORTS. NO DEVICE HISTORY RECORD REVIEW COULD BE DONE AS THE MODEL NUMBER WAS NOT CONFIRMED AND WERE UNABLE TO OBTAIN A SERIAL/LOT NUMBER. THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO SPECIFIC MODEL OF MORCELLATOR PROVIDED, AND THE LETTER WAS SERVED TO OTHER MANUFACTURERS OF MORCELLATORS. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. 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 RECEIVED A LEGAL DOCUMENT WHICH STATES, IN 2012 A PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE WITH THE USE OF AN UNIDENTIFIED POWER MORCELLATOR. THE LEGAL DOCUMENT INDICATES; AS A RESULT OF THE USE OF THE POWER MORCELLATOR, THE PATIENT DEVELOPED LEIOMYOSARCOMA AND ULTIMATELY EXPIRED ON (B)(6) 2016. IT WAS ALSO NOTED, THAT PRIOR TO UNDERGOING SURGERY, THE PATIENT WAS NOT WARNED OF THE HIGH-RISK THAT THE USE OF A LAPAROSCOPIC POWER MORCELLATOR COULD CAUSE THE SPREAD AND RECURRENCE CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303918 UNKNOWN MORCELLATOR GEI GYRUS ACMI, INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death