BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ

    MDR report key: 52488 · Received November 26, 1996

    Report

    Report Number
    52488
    Event Type
    Malfunction
    Date Received
    November 26, 1996
    Date of Event
    November 20, 1996
    Report Date
    November 26, 1996
    Manufacturer
    STORZ
    Product Code
    FGK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING THE STONE CRUSHER (NUMBER 18 NOTED ON THE HANDLE), THE EQUIPMENT MALFUNCTIONED AND REMAINED IN THE OPEN POSITION. THE PHYSICIAN PERFORMED A URETHRAL MEATOTOMY AND WAS ABLE TO REMOVE THE INSTRUMENT. A SECOND STONE CRUSHER WAS OBTAINED (NUMBER 25 NOTED ON THE HANDLE). DURING THE PROCEDURE THE INSTRUMENT BROKE. THE X-RAY SHOWED THAT THE JAWS WERE OPEN AND ACTUALLY HAD A 90% ANGLE UP. ATTEMPTS WERE MADE TO TRY TO CLOSE THE JAWS, AS DISCUSSED WITH THE CO. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE INSTRUMENT. A MIDLINE INCISION WAS MADE. A PIECE OF STONE WAS REMOVED, THE STONE CRUSHING FORCEPS WERE STRAIGHTENED AND ABLE TO BE REMOVED THROUGH THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ STONE CRUSHER FGK STORZ 27074 B *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR