BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTOCUT

    MDR report key: 5418707 · Received February 9, 2016

    Report

    Report Number
    5418707
    Event Type
    Death
    Date Received
    February 9, 2016
    Date of Event
    June 12, 2012
    Report Date
    January 4, 2016
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA INC.
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY WITH MORECELLATION OF UTERINE FIBROIDS AND TISSUE. THIS LEAD TO RECURRENT DISEASE AND EVENTUAL PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76604 ROTOCUT LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET KARL STORZ ENDOSCOPY-AMERICA INC. 20711120

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death NO