BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINA POWER MORCELLATOR

    MDR report key: 8320285 · Received February 7, 2019

    Report

    Report Number
    MW5083832
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    July 19, 2017
    Report Date
    February 6, 2019
    Manufacturer
    LINA MEDICAL INTERNATIONAL OPERATIONS AG
    Product Code
    NWV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT POWER MORCELLATION USING THE VERSION OF THIS DEVICE MANUFACTURED BY LINA DURING THE COURSE OF A ROBOTIC MYOMECTOMY PROCEDURE FOR SYMPTOMATIC FIBROID DISEASE, ASSUMED TO BE BENIGN. THE PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL IN (B)(6). THE PATIENT WAS NOT INFORMED OF THE POSSIBILITY OF A UTERINE SOFT TISSUE SARCOMA MASQUERADING AS A FIBROID DISEASE- DESPITE CONCERNING FEATURES AND CLINICAL SYMPTOMS. THE PATIENT WAS NOT CONSENTED FOR THE USE OF A POWER MORCELLATOR DURING THE MYOMECTOMY OPERATION. WITHIN SEVERAL MONTHS, THE PATIENT DEVELOPED EXTENSIVE ABDOMINAL SARCOMATOSIS AND IS NOW BATTLING AN ADVANCED STAGE IATROGENIC ABDOMINAL SARCOMATOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106793 LINA POWER MORCELLATOR LAPAROSCOPE, GYNECOLOGIC AND ACCESSORIES NWV LINA MEDICAL INTERNATIONAL OPERATIONS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| L| O| R| S