BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25KHZ SPETZLER BARACUDA TIP

    MDR report key: 3221687 · Received July 11, 2013

    Report

    Report Number
    0001811755-2013-01628
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010309
    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 HANDPIECE IS RECEIVED AND THE QUALITY INVESTIGATION HAS BEEN COMPLETED. PRODUCT DISCARDED BY USER FACILITY.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMMENT OF THE TIP SLEEVE MELTING WAS NOT DUPLICATED OR CONFIRMED. UPON DISASSEMBLY, THERE WERE NO OBSERVED FAILURES THAT COULD LEAD TO THE REPORTED EVENT. THE DEVICE WAS CLEANED, LUBRICATED, AND ADJUSTED. BASED ON THE MANUFACTURER'S INSTRUCTIONS FOR USE, LACK OF IRRIGATION TO THE TIP MAY CAUSE OR CONTRIBUTE TO A MELTED TIP, HOWEVER THIS WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 25KHZ SPETZLER BARACUDA TIP WAS BEING USED IN A CRANIOTOMY WHEN THE TIP SLEEVE MELTED. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 25KHZ SPETZLER BARACUDA TIP WAS BEING USED IN A CRANIOTOMY WHEN THE TIP SLEEVE MELTED. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319478 25KHZ SPETZLER BARACUDA TIP INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNIVERSAL HANDPIECE5450820000| UNIVERSAL HANDPIECE5450-820-000