BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ

    MDR report key: 300042 · Received October 13, 2000

    Report

    Report Number
    2020550-2000-00023
    Event Type
    Injury
    Date Received
    October 13, 2000
    Date of Event
    September 21, 2000
    Report Date
    October 13, 2000
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    KCD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ESOPHAGUS DILATION, THE TIP OF THE DILATOR ALLEGEDLY CAME OFF INSIDE THE PT. THE TIP WAS CAUGHT IN THE TUMOR AND WAS NOT RETRIEVABLE. PT WAS BROUGHT BACK THE NEXT DAY AND AN INCISION WAS MADE TO RETRIEVE THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ FLEXIBLE BOUGIE DILATOR KCD KARL STORZ GMBH & CO. 10392A NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention