BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE HANDPIECE WITH HIGH FLOW TIP

    MDR report key: 3935590 · Received July 15, 2014

    Report

    Report Number
    0001811755-2014-02489
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DISCARDED THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERPULSE HANDPIECE WITH HIGH FLOW TIPS WERE BEING USED IN A PROCEDURE WHEN THEY CONTINUED TO FALL OFF THE HANDPIECE. IT WAS CONFIRMED THAT THE TIP AND NO FRAGMENTS FROM THE TIP FELL INTO THE SURGICAL SITE. 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
    412186 INTERPULSE HANDPIECE WITH HIGH FLOW TIP LAVAGE, JET FQH STRYKER INSTRUMENTS-KALAMAZOO 14044012

    Patients

    Seq Age Sex Outcome Treatment
    1