BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25KHZ PAYNER 360 TIP

    MDR report key: 3951639 · Received July 23, 2014

    Report

    Report Number
    0001811755-2014-02615
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE TIP COVER BREAKING WAS CONFIRMED DURING SERVICE INSPECTION. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE WAS SCRAPPED AT THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 25KHZ PAYNER 360 TIP WAS BEING USED IN A PROCEDURE WHEN IT WAS DISCOVERED THAT THE WHITE SHEATH WAS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK UP DEVICE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 25KHZ PAYNER 360 TIP WAS BEING USED IN A PROCEDURE WHEN IT WAS DISCOVERED THAT THE WHITE SHEATH WAS BROKEN. 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
    430175 25KHZ PAYNER 360 TIP INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI 0309450

    Patients

    Seq Age Sex Outcome Treatment
    1