BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 TOGA, ZIPPER, LARGE/EXTRA LARGE"

    MDR report key: 3419452 · Received October 18, 2013

    Report

    Report Number
    0001811755-2013-02570
    Event Type
    Malfunction
    Date Received
    October 18, 2013
    Date of Event
    September 27, 2013
    Report Date
    September 27, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYA
    PMA / PMN Number
    K070078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED BY A MANUFACTURER SERVICE TECHNICIAN THROUGH VISUAL INSPECTION. THE REPORTED EVENT COULD HAVE BEEN CAUSED BY A MANUFACTURING ISSUE SINCE THE DEBRIS WAS CONTAINED INSIDE THE STERILE PACKAGING PRIOR TO USE, AND THE PRODUCT IS A SINGLE USE DEVICE. THE DEVICE WAS DESTRUCTIVELY TESTED BY THE MANUFACTURER AND WAS NOT RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STERILE PACKAGING OF THE HOODS WERE OPENED AT THE USER FACILITY IN PREPARATION FOR A SURGICAL PROCEDURE, A WHITE SUBSTANCE CAME OUT OF THE STERILE PACKAGING. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STERILE PACKAGING OF THE HOODS WERE OPENED AT THE USER FACILITY IN PREPARATION FOR A SURGICAL PROCEDURE, A WHITE SUBSTANCE CAME OUT OF THE STERILE PACKAGING. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535002 T4 TOGA, ZIPPER, LARGE/EXTRA LARGE" GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO 13060955

    Patients

    Seq Age Sex Outcome Treatment
    1