BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH LL 100 CRYOSURGICAL SYSTEM

    MDR report key: 1012406 · Received March 11, 2008

    Report

    Report Number
    1219739-2008-00002
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 7, 2008
    Report Date
    March 11, 2008
    Manufacturer
    WALLACH SURGICAL DEVICES
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT WAS SUBJECTED TO A TWISTING ACTION SUBSEQUENT TO FINAL ACCEPTANCE OF THIS PRODUCT. THE TWISTING OF THE INTERNAL TUBING MOST LIKELY CAUSED A BLOCKAGE OF RETURN GAS FLOW TO THE EXHAUST HOUSING RESULTING IN THE RUPTURED TUBING. RECORDS INDICATE THIS UNIT WAS SUBJECTED TO A FINAL INSPECTION, WHICH INCLUDED A FUNCTIONAL TEST PRIOR TO RELEASE FOR DISTRIBUTION. FINAL FUNCTIONAL TESTING WOULD NOT BE POSSIBLE WITH THE INTERNAL TWISTING CONDITION EVIDENCED. THIS IS NOT A CONDITION FREQUENTLY INCURRED BY THE REPAIR DEPARTMENT. THIS CONDITION HAS NOT BEEN IDENTIFIED AS A REPEAT COMPLAINT.

    Description of Event or Problem · 1

    PHYSICIAN HEARD A LOUD BANG WHILE TESTING THE LL 100 CRYOSURGICAL UNIT PRIOR TO USE. THE WHITE TUBING BURST AND THE SURGEON FELT SOMETHING HIT HIS LEG. A PIECE OF THE SILICONE TUBING WAS MISSING FROM TUBING WHERE IT BURST.

    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