BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH LL 100 CRYOSURGICAL SYSTEM

    MDR report key: 1010170 · Received March 6, 2008

    Report

    Report Number
    1219739-2008-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2008
    Date of Event
    January 31, 2008
    Report Date
    March 6, 2008
    Manufacturer
    WALLACH SURGICAL DEVICES
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED AND PERFORMANCE TESTS CONDUCTED THAT DEMONSTRATED THE DEVICE FUNCTIONED AS INTENDED. THE CONCLUSION WAS THAT USER ERROR CAUSED THE EVENT. CUSTOMER WAS CONSULTED ON PROPER USE OF THE DEVICE.

    Description of Event or Problem · 1

    WHEN PHYSICIAN PUT THE TIP INTO THE FREEZER AND ACTIVATED THE UNIT, THE TIP FLEW OFF AND HIT THE WALL. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLACH LL 100 CRYOSURGICAL SYSTEM CRYOSURGICAL FREEZER GEH WALLACH SURGICAL DEVICES 900001

    Patients

    Seq Age Sex Outcome Treatment
    1