BEUDAMED
    FDA Adverse Event Death Summary report: N

    KARL STORZ

    MDR report key: 2319897 · Received October 29, 2011

    Report

    Report Number
    9610617-2011-00044
    Event Type
    Death
    Date Received
    October 29, 2011
    Date of Event
    October 6, 2011
    Report Date
    October 27, 2011
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    HGK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE NURSE COORDINATOR WHO REPORTED THE INCIDENT, THE EVENT WAS NOT RELATED TO THE USE OF THE FETOSCOPY EQUIPMENT. THE EQUIPMENT WILL NOT BE RETURNED FOR EVAL. A CERTAIN PERCENTAGE OF DEATHS, INCLUDING INTRAUTERINE FETAL DEATH, IS ANTICIPATED FOR TTTS.

    Description of Event or Problem · 1

    THE DATA AND INFO CONTAINED HEREIN IS BEING SUBMITTED TO THE FDA TO COMPLY WITH THE REGULATIONS (21 CFR PART 803) PERTAINING TO MEDICAL DEVICE REPORTING. THIS MDR IS BASED ON PRELIMINARY INFO RECEIVED BY KARL STORZ, WHO HAS NOT CONCLUSIVELY DETERMINED THE CAUSE OF THE ADVERSE EVENT. THIS MDR IS, THEREFORE, NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION THAT A REPORTABLE EVENT OCCURRED OR THAT ANY KARL STORZ PRODUCTS WERE CAUSALLY RELATED TO THE INCIDENT. A PT PREGNANT WITH IDENTICAL TWINS WAS DIAGNOSED WITH TTTS (TWINS-TO-TWIN TRANSFUSION SYNDROME). SELECTIVE LASER PHOTOCOAGULATION USING KARL STORZ HDE FETOSCOPY INSTRUMENTS WAS PERFORMED ON (B)(6) 2011. THE FOLLOWING MORNING ((B)(6) 2011) DURING F/U CARDIAC ECHO TO CHECK CARDIAC FUNCTION, IT WAS DISCOVERED THAT THE RECIPIENT FETUS HAD EXPIRED. CUSTOMER REPORTED THAT PRIOR TO THE PROCEDURE, THE RECIPIENT FETUS HAD DECREASED CARDIAC FUNCTION AND THAT THE DEATH WAS NOT RELATED TO THE FETOSCOPY EQUIPMENT. POST PROCEDURE, THE MOTHER AND DONOR FETUS ARE REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ FETOSCOPE HGK KARL STORZ GMBH & CO. KG 26008AA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death