BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDEO MEDIASTINOSCOPE

    MDR report key: 13052546 · Received December 21, 2021

    Report

    Report Number
    9610617-2021-00095
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    March 1, 2021
    Report Date
    December 21, 2021
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    EWY
    UDI-DI
    04048551425718
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPARED TO THE PREDICATE DEVICE, THE CURRENT DEVICE HAS A CHANGED DESIGN ON THE DEVICE TIP. AS THE TIP IS CHAMFERED ACCORDING TO SPECIFICATION, THE ISSUE WAS THEREFORE FOUND TO BE A SPECIFICATION ISSUE AND DESIGN RELATED. KARL STORZ DECIDED TO RECALL ALL AFFECTED PRODUCTS - REFER TO INTERNAL FSCA REFERENCE # (B)(4). NONE OF THE DEVICES AFFECTED BY THE RECALL HAVE BEEN DISTRIBUTED IN THE U.S. AT THE TIME OF THE OCCURRENCE OF THE ADVERSE EVENT AND THE INITIATION OF THE RECALL, THE DEVICE HAS NOT BEEN CLEARED BY THE FDA. THIS ADVERSE EVENT IS NOW REPORTED RETROSPECTIVELY ONLY BECAUSE IT WAS REQUESTED DURING FDAS REVIEW OF SUBMISSION K213194.

    Description of Event or Problem · 0

    AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): "DURING A MEDIA STINOSCOPY WITH OUR NEWLY PURCHASED VIDEO MEDIASTINOSCOP, APPARENTLY A TRACHEA TEAR HAS OCCURRED DURING THE INSERTION OF THE SCOPE." (MANUFACTURER'S INTERNAL COMPLAINT # (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951574 VIDEO MEDIASTINOSCOPE RIGID MEDIASTINOSCOPE EWY KARL STORZ SE & CO. KG 10973HD 04048551425718

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention