BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 109731 · Received July 7, 1997

    Report

    Report Number
    109731
    Event Type
    Malfunction
    Date Received
    July 7, 1997
    Date of Event
    January 23, 1997
    Report Date
    January 24, 1997
    Manufacturer
    KARL STORZ
    Product Code
    FGK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR WAS DOING CYSTOSCOPY, LITHOPOXY, TRANS URETHRAL RESECTION OF THE PROSTATE (TURP), USING THE HENDRICKS OPTICAL STONE CRUSHING FORCEP. WHILE CRUSHING STONE IN BLADDER THE INSTRUMENT BROKE WITH JAWS IN AN OPEN POSITION. THE DR WAS LEFT WITH NO OPTION BUT TO REMOVE THE INSTRUMENT THROUGH THE URETHRA; INSTRUMENT INTACT; JAWS FIXED OPEN; NO RETAINED PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LITHOTRITE FGK KARL STORZ * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR