BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ

    MDR report key: 3925217 · Received June 12, 2014

    Report

    Report Number
    3925217
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    October 18, 2013
    Report Date
    December 6, 2013
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEONS HAD INSERTED A SIZE 28 FRENCH RESECTASCOPE INTO A PATIENT UNDERGOING RESECTION OF A BLADDER TUMOR, AND THE CERAMIC TIP OF THE RESECTASCOPE BROKE OFF. THE SURGEONS WERE ABLE TO RETRIEVE ALL BUT A VERY SMALL PIECE. NO RESPONSE FOR THE MANUFACTURER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348815 STORZ RESECTOSCOPE FJL KARL STORZ ENDOSCOPY-AMERICA, INC. 27040SM *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR