BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAXIAL HIGH FLOW TIP

    MDR report key: 3881962 · Received June 18, 2014

    Report

    Report Number
    0001811755-2014-02185
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 22, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION HAS BEEN COMPLETED. NOT YET RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE REPORTED UNIT WAS NOT AVAILABLE TO THE MANUFACTURER FOR EVALUATION SINCE IT WAS DISCARDED BY THE CUSTOMER, THEREFORE,THE CLAIMED CONDITION COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COAXIAL HIGH FLOW TIP CAME APART DURING USE IN A PROCEDURE. IT WAS CONFIRMED THAT NOTHING FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT OR USER INJURIES AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COAXIAL HIGH FLOW TIP CAME APART DURING USE IN A PROCEDURE. IT WAS CONFIRMED THAT NOTHING FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT OR USER INJURIES AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356979 COAXIAL HIGH FLOW TIP LAVAGE, JET FQH STRYKER INSTRUMENTS-KALAMAZOO 13339012

    Patients

    Seq Age Sex Outcome Treatment
    1