BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER TUBE WITH CERAMIC BEAK

    MDR report key: 7428297 · Received April 13, 2018

    Report

    Report Number
    7428297
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    April 10, 2018
    Report Date
    April 12, 2018
    Manufacturer
    KARL STORZ GMBH CO. KG
    Product Code
    FBO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN THE OPERATING ROOM (OR) FOR A CYSTOSCOPY AND TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). INNER SHEATH OF KARL STORZ INSTRUMENT HAD THE TIP COVERED IN PLASTIC. PLASTIC CRACKED AND PIECES OF PLASTIC BROKE OFF INTO THE PATIENT BLADDER. DR. IRRIGATED AND USED GRASPERS TO RETRIEVE THE PIECES OF PLASTIC. HE IRRIGATED THE BLADDER COPIOUSLY AND INSPECTED THE BLADDER THOROUGHLY UNDER VIDEO ENDOSCOPY TO ENSURE NO PIECES WERE LEFT IN THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270924 INNER TUBE WITH CERAMIC BEAK CYSTOURETHROSCOPE FBO KARL STORZ GMBH CO. KG 27050XA SW06

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR NO