BEUDAMED
    FDA Adverse Event Death Summary report: N

    KARL STORZ MORCELLATOR

    MDR report key: 5123555 · Received October 2, 2015

    Report

    Report Number
    5123555
    Event Type
    Death
    Date Received
    October 2, 2015
    Date of Event
    October 17, 2014
    Report Date
    September 25, 2015
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    NLM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD HISTORY OF FIBROIDS AND MENORRHAGIA WITH 8-CM FIBROID ON MRI; MRI WAS TAKEN AT OUTSIDE FACILITY AND INTERPRETED AS NEGATIVE. ENDOCERVICAL BIOPSY WAS ALSO NEGATIVE. HOWEVER, AFTER THE ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH MORCELLATION OF UTERUS, POST-OPERATIVE PATHOLOGY FOUND HIGH-GRADE LEIOMYOSARCOMA. CASE IS IN LITIGATION. FIRST NOTICE WAS THE LAWSUIT AND THE PATIENT ALLEGATION CONTAINED THEREIN. PRELIMINARY INVESTIGATION INDICATES THAT THE STANDARD OF CARE WAS FOLLOWED AND THAT THE PATIENT HAD PROGRESSED TO STAGE 4 LEIOMYOSARCOMA PRIOR TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654202 KARL STORZ MORCELLATOR LAPAROSCOPE, GENERAL & PLASTIC SURGERY NLM KARL STORZ ENDOSCOPY-AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death