BEUDAMED
    FDA Adverse Event Death Summary report: N

    PKS PLASMASORD (5/PK)

    MDR report key: 5661356 · Received May 17, 2016

    Report

    Report Number
    2951238-2016-00432
    Event Type
    Death
    Date Received
    May 17, 2016
    Date of Event
    January 25, 2010
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. 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) 2010, A PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR THE REMOVAL OF UTERINE FIBROIDS. A PKS PLASMASORD BIPOLAR MORCELLATOR WAS USED DURING THIS PROCEDURE. THE PATHOLOGY FROM THIS PROCEDURE REVEALED EXTENSIVE LEIOMYOSARCOMA. USE OF THE POWER MORCELLATOR SPREAD THIS TISSUE THROUGH THE PATIENT'S ABDOMEN AND PELVIS. ON (B)(6) 2010, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, TRACHELECTOMY, BILATERAL PELVIC LYMPH NODES OMENTECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY, AND APPENDECTOMY. THERE WAS NO EVIDENCE OF RESIDUAL DISEASE AT THAT TIME. ON (B)(6) 2010, AFTER STAGING AND 3 CYCLES OF CHEMOTHERAPY, A PET SCAN REVEALED A LARGE LOWER PELVIC MIDLINE MASS COMPATIBLE RECURRENCE OF LEIOMYOSARCOMA. ON (B)(6) 2010, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, RADICAL TUMOR DEBULKING, RECTOSIGMOID RESECTION WITH END-COLOSTOMY AND HERNIA REPAIR. MULTIPLE TUMORS WERE REMOVED IN THE ABDOMINAL AND PELVIC REGION ALONG WITH A RESECTION OF HER RECTOSIGMOID COLON. AFTER THIS PROCEDURE, THE DISEASE CONTINUED TO SPREAD, AND THE PATIENT SUCCUMBED TO HER ILLNESS ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314767 PKS PLASMASORD (5/PK) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GYRUS AMCI, INC. 962000PK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death