BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAIRISON DISPOSABLE TUBES

    MDR report key: 1070818 · Received July 3, 2008

    Report

    Report Number
    2916714-2008-00015
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 25, 2008
    Manufacturer
    AESCULAP AG & CO, KG
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TUBING BLEW DURING USE. SURGEON WAS HAVING A SMOOTH TRIAL AND LIKED THE DEVICE, WHEN ALL OF A SUDDEN, TUBING BLEW UP. THE DISPOSABLE TUBING HAS A HOLE ABOUT THE SIZE OF A SILVER DOLLAR ABOUT 1/2 WAY DOWN. NO PATIENT INJURY. SURGERY WAS PROLONGED FOR LESS THAN FIVE MINUTES TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAIRISON DISPOSABLE TUBES HAE AESCULAP AG & CO, KG FK888SU 4501386268

    Patients

    Seq Age Sex Outcome Treatment
    1