BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ

    MDR report key: 3193090 · Received June 10, 2013

    Report

    Report Number
    3010202439-2013-00022
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    March 28, 2013
    Report Date
    June 7, 2013
    Manufacturer
    KARL STORZ ENDOSCOPYAMERICA INC.
    Product Code
    HGK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR USED THE TTTS SET TO CONDUCT AN INTERUTERINE ELECTRICAL COAGULATION OF UMBILICAL CORD ON TWIN FETUSES (SELECTIVE REDUCTION); THERE WAS SIGNIFICANT UMBILICAL CORD ENTANGLEMENT WITH ONE OF THE FETUSES. THE DOCTOR'S INTENT WAS TO TERMINATE FETUS B AND HE COMPLETED THE PROCEDURE AND CONSIDERED IT SUCCESSFUL. ON THE 6TH DAY POST-OP, AN ULTRASOUND WAS PERFORMED; IT SHOWED THAT TWIN B REMAINED VIABLE, BUT TWIN A HAD EXPIRED. THE DOCTOR TERMINATED THE WRONG FETUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262144 KARL STORZ RIGID TTTS FETOSCOPY INSTRUMENTS HGK KARL STORZ ENDOSCOPYAMERICA INC. 26008BUA-KT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other