BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP

    MDR report key: 3802644 · Received May 9, 2014

    Report

    Report Number
    0001811755-2014-01689
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP WAS BEING USED IN A PROCEDURE WHEN THE TIP BROKE OFF. IT WAS CONFIRMED THAT THE TIP OR NO FRAGMENTS FROM THE TIP 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
    281971 INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP LAVAGE, JET FQH STRYKER INSTRUMENTS-PUERTO RICO 31610011405901200

    Patients

    Seq Age Sex Outcome Treatment
    1