BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ

    MDR report key: 17516630 · Received August 11, 2023

    Report

    Report Number
    MW5123579
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    July 22, 2015
    Report Date
    August 13, 2015
    Manufacturer
    STORZ
    Product Code
    KAK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE REPORTED EVENT WAS THAT THE PATIENT SUFFERED TORN SUBMUCOSAL TISSUE. THE SURGEON NOTED HAVING USED A STORZ BRAND BALL PROBE TO MEDIALIZE THE UNCINATE PROCESS AND SUSPECTED THAT DOING THIS RESULTED IN A TEAR IN THE MUCOUS MEMBRANE OF THE INFUNDIBULUM. THE PATIENT WAS GIVEN ICE TO APPLY TO THE CHEEK AND WAS CAUTIONED TO NOT BLOW THE NOSE. THERE WAS NO REPORT OF ADDITIONAL INTERVENTION OR SEQUELAE RELATED TO THE EVENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869902 STORZ PROBE, ENT KAK STORZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown