BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ ENDOSCOPY-AMERICA, INC.

    MDR report key: 10431213 · Received August 19, 2020

    Report

    Report Number
    MW5096153
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    August 17, 2020
    Report Date
    August 18, 2020
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CERAMIC TIP TO THE RESECTOSCOPE BROKE OFF INSIDE THE PT'S BLADDER. THE PIECE WAS RETRIEVED. SCOPE WAS RETURNED TO MFR ON 08/18/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889421 KARL STORZ ENDOSCOPY-AMERICA, INC. RESECTOSCOPE FJL KARL STORZ ENDOSCOPY-AMERICA, INC. 27040XA XT03

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR