BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1873364 · Received October 13, 2010

    Report

    Report Number
    9613347-2010-00032
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 7, 2010
    Manufacturer
    STORZ MEDICAL AG
    Product Code
    LNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF MALFUNCTION OF UNIT. A SERVICE EVALUATION WAS PERFORMED THE DAY BEFORE THIS PROCEDURE AND UNIT PASSED ALL TESTS.

    Description of Event or Problem · 1

    ALLEGEDLY, AT THE CONCLUSION OF A LITHOTRIPSY PROCEDURE, THE PT WAS DIAGNOSED AS HAVING A POST TREATMENT PERINEPHRIC HEMATOMA. PT WAS HOSPITALIZED AND LATER RELEASED. THERE WAS NO REPORT OF DEVICE MALFUNCTION DOCTOR ADMINISTERED 3000 SHOCKS AT LEVEL 7; THIS EXCEEDED DIRECTIONS CONTAINED IN LABELING: INDICATIONS AND CONTRAINDICATIONS - PRECAUTIONS LABELING: "IN REFERENCE TO RETREATMENT, IT IS RECOMMENDED THAT PTS SHOULD BE LIMITED TO THREE TREATMENT SESSIONS OF 2000 PRESSURE WAVES EACH TO THE SAME FOCAL REGION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ SLX LITHOTRIPTOR LNS STORZ MEDICAL AG 3819 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization