BEUDAMED
    FDA Adverse Event Death Summary report: N

    KARL STORZ RIGID TTTS FETOSCOPY INSTRUMENT SET

    MDR report key: 3161525 · Received June 4, 2013

    Report

    Report Number
    MW5030461
    Event Type
    Death
    Date Received
    June 4, 2013
    Date of Event
    March 28, 2013
    Report Date
    June 4, 2013
    Manufacturer
    KARL STORZ ENDOSCOPY AMERICA, INC
    Product Code
    HGK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS TO PERFORM AN INTRAUTERINE ELECTROCOAGULATION OF UMBILICAL CORD OF TWIN B. THERE WAS SIGNIFICANT CORD ENTANGLEMENT. THE PROCEDURE WAS COMPLETED AND BELIEVED TO HAVE BEEN SUCCESSFUL. ON THE SIXTH DAY POST-OP AN ULTRASOUND WAS PERFORMED AND IT WAS DETERMINED THAT TWIN B REMAINED VIABLE, HOWEVER, THERE WAS A DEMISE OF TWIN A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247311 KARL STORZ RIGID TTTS FETOSCOPY INSTRUMENT SET RIGID TTTS FETOSCOPE HGK KARL STORZ ENDOSCOPY AMERICA, INC 26008AA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death