BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS PLASMASORD (5/PK)

    MDR report key: 5661061 · Received May 17, 2016

    Report

    Report Number
    2951238-2016-00430
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    June 17, 2013
    Report Date
    May 17, 2016
    Manufacturer
    GYRUS AMCI, INC.
    Product Code
    GEI
    PMA / PMN Number
    PK080093
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE CASE REPORT DOES NOT PROVIDE ADDITIONAL INFORMATION ABOUT THE DEVICE OR LOCATION WHERE THE PROCEDURE WAS PERFORMED. THE CAUSE OF THE EVENT CAN NOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A LEGAL DOCUMENT ON (B)(6) 2016 WHICH ALLEGED THAT ON (B)(6) 2013, A PATIENT UNDERWENT GYNECOLOGIC SURGERY FOR WHAT WAS THOUGHT TO BE BENIGN FIBROID TUMORS. A PKS PLASMASORD BIPOLAR MORCELLATOR WAS USED DURING THIS PROCEDURE. THE PATIENT CLAIMS THAT THE RISKS ASSOCIATED WITH THE USE OF THIS DEVICE WERE NOT COMMUNICATED. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH ADVANCED HIGH-GRADE METASTATIC PELVIC/UTERINE LEIOMYOSARCOMA, STAGE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314627 PKS PLASMASORD (5/PK) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GYRUS AMCI, INC. 962000PK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening