BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOTRITE

    MDR report key: 127954 · Received October 16, 1997

    Report

    Report Number
    MW1012346
    Event Type
    Malfunction
    Date Received
    October 16, 1997
    Date of Event
    October 9, 1997
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA INC
    Product Code
    FGK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LITHOTRITE CAUGHT IN THE CYSTOSCOPE- M.D. UNABLE TO REMOVE LITHOTRITE FROM CYSTOSCOPE SHEATH. IT APPEARED LITHOTRITE MALFUNCTIONED CAUSING THE JAWS NOT TO OPEN AND GETTING STUCK IN CYSTOSCOPE SHEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR