BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS PLASMASORD (5/PK)

    MDR report key: 7920915 · Received September 28, 2018

    Report

    Report Number
    2951238-2018-00587
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    January 11, 2010
    Report Date
    September 28, 2018
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K080093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED. IN ADDITION, INSUFFICIENT INFORMATION WAS PROVIDED BY THE USER FACILITY AS MULTIPLE ATTEMPTS WERE MADE TO GATHER MORE DETAILED INFORMATION REGARDING THE REPORTED EVENT, HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. OLYMPUS WILL CONTINUE TO INVESTIGATE THIS COMPLAINT TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED COMPLAINT. 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 ON (B)(6) 2018 ALLEGING THAT A PATIENT WAS DIAGNOSED WITH STAGE IVB LEIOMYOSARCOMA (LMS) AFTER UNDERGOING A HYSTERECTOMY PROCEDURE FOR PRESUMED BENIGN FIBROIDS ON (B)96) 2010 WITH A BIPOLAR MORCELLATOR. THE LEGAL DOCUMENT ALLEGES THAT THE SURGEON USED THE MORCELLATOR TO CUT THROUGH A TUMOR AND A UTERINE CONFINED MALIGNANCY WAS RELEASED RESULTING IN THE SPREAD OF TUMOR CELLS IN THE PATIENT¿S PELVIS. THE LEGAL DOCUMENT REPORTS THAT ON (B)(6) 2017, A PELVIC CT SCAN WAS PERFORMED ON THE PATIENT WHICH SHOWED A TWELVE CENTIMETER MASS IN THE PATIENT¿S PELVIS. FURTHER TESTING DIAGNOSED THE MASS AS LMS. THE PATIENT IS ALLEGEDLY UNDERGOING PALLIATIVE CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760688 PKS PLASMASORD (5/PK) BI-POLAR MORCELLATOR GEI GYRUS ACMI, INC 962000PK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R