BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS PLASMA MORCELLATOR

    MDR report key: 4842263 · Received June 12, 2015

    Report

    Report Number
    2951238-2015-00215
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    August 26, 2009
    Report Date
    May 18, 2015
    Manufacturer
    GYRUS ACMI INC
    Product Code
    HET
    PMA / PMN Number
    K080093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. HOWEVER, OLYMPUS CANNOT CONCLUSIVELY DETERMINE THE EXACT CAUSE OF THE REPORTED PHENOMENON. OLYMPUS WILL CONTINUE TO INVESTIGATE THIS REPORT, AND IF ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE USING A MORCELLATOR. IT WAS ALLEGED THAT THE USE OF THE MORCELLATOR LED TO THE UPSTAGING, DISSEMINATION, AND SEEDING OF MALIGNANT CELLS. THE PATIENT ALSO HAD AN OCCULT UTERINE MALIGNANCY THAT WAS LATER DIAGNOSED AS LEIOMYOSARCOMA. OLYMPUS CONTACTED THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385073 PKS PLASMA MORCELLATOR PLASMASORD HET GYRUS ACMI INC 962000PK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1