BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS PLASMASORD (5/PK)

    MDR report key: 7287038 · Received February 21, 2018

    Report

    Report Number
    2951238-2018-00124
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    October 26, 2010
    Report Date
    February 21, 2018
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    PK080093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS FOLLOWED UP WITH THE ATTORNEY ON (B)(6) 2017, TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND WAS INFORMED THAT PATIENT UNDERWENT THE INITIAL PROCEDURE AT (B)(6) HOSPITAL IN MISSOULA, MT. THE PATIENT HAS STARTED A LIFE-LONG COURSE OF HORMONE THERAPY WITH THE PRESCRIPTION DRUG, MEGACE. THE ATTORNEY ALSO REPORTED THAT IN THE LAST SIXTY DAYS PATIENT UNDERWENT A THIRD PROCEDURE TO REMOVE THE FALLOPIAN TUBE TUBES, OVARIES AND CERVIX. IT IS UNKNOWN IF THIS WAS OUTPATIENT OR INPATIENT PROCEDURE. THE PATIENT IS CURRENTLY HOME AND UNDER MEDICAL MONITORING. AS PART OF OUR INVESTIGATION, ON (B)(6) 2017, OLYMPUS ALSO FOLLOWED UP WITH THE (B)(6)HOSPITAL¿S RISK MANAGER WHO CONFIRMED THAT THE PATIENT WAS SEEN THERE; HOWEVER, NO FURTHER INFORMATION CAN BE PROVIDED. 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 A RECURRENT LOW GRADE ENDOMETRIAL STROMAL SARCOMA (LG-ESS) AFTER UNDERGOING A SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2010 WITH A BIPOLAR MORCELLATOR. THE LEGAL DOCUMENT ALLEGES THAT THE OPERATIVE REPORT INDICATES THAT THE SURGEON USED THE DEVICE TO CUT AND MINCE THE PATIENT¿S UTERUS. THE LEGAL DOCUMENT REPORTS THAT IN 2017, THE PATIENT PRESENTED TO THE DOCTOR WITH SEVERE ABDOMINAL PAIN. A CT SCAN WAS PERFORMED AND AN ABDOMINAL MASS WAS DISCOVERED. ON (B)(6) 2017, THE PATIENT UNDERWENT LAPAROSCOPIC ASSIGNED SIGMOID COLECTOMY PROCEDURE TO REMOVE THE ABDOMINAL MASS. THE LEGAL DOCUMENT REPORTS THAT MASS WAS IDENTIFIED BY PATHOLOGY AS A SARCOMA. THE PATIENT REMAINED HOSPITALIZED FOR AN UNKNOWN DURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128917 PKS PLASMASORD (5/PK) PLASMASORD GEI GYRUS ACMI, INC 962000PK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R