BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 HOOD

    MDR report key: 2964248 · Received February 15, 2013

    Report

    Report Number
    0001811755-2013-00292
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYA
    PMA / PMN Number
    K993148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    DURING THE VISUAL INSPECTION OF THE PRODUCT, A HAIR WAS FOUND INSIDE THE STERILE POUCH. A MANUFACTURING ISSUE WAS DETERMINED TO BE A PROBABLE CAUSE OF THE HAIR IN THE PACKAGING. A NONCONFORMANCE WAS OPENED TO EVALUATE THE EVENT.THE HOOD WAS NOT RETURNED TO THE USER FACILITY, AS IT IS NOT A REPAIRABLE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, A SMALL OPENING SLIGHTLY BIGGER THAN A PIN HOLE WAS FOUND IN THE STERILE PACKAGING OF THE HOOD. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    UPON FOLLOW UP THE USER FACILITY REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE, A HAIR, NOT A SMALL HOLE, WAS FOUND IN THE STERILE PACKAGING OF THE HOOD. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67189 T4 HOOD GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO 2122117

    Patients

    Seq Age Sex Outcome Treatment
    1