BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EURO INRPLS HP W/HIGH FLOW TIP

    MDR report key: 3863956 · Received June 10, 2014

    Report

    Report Number
    0001811755-2014-02108
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERPULSE HANDPIECE WITH HIGH FLOW TIP WAS BEING USED IN A PROCEDURE WHEN A BLACK SUBSTANCE WAS OBSERVED TO COME OUT OF THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK UP DEVICE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340915 EURO INRPLS HP W/HIGH FLOW TIP LAVAGE, JET FQH STRYKER INSTRUMENTS-PUERTO RICO 14009012

    Patients

    Seq Age Sex Outcome Treatment
    1