BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25KHZ SPETZLER BARACUDA TIP

    MDR report key: 1813003 · Received August 11, 2010

    Report

    Report Number
    1811755-2010-00925
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 26, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    LFL
    PMA / PMN Number
    K020220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ULTRASONIC ASPIRATOR TIP WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED, HOWEVER, THE QUALITY INVESTIGATION IS STILL ONGOING. A VISUAL EXAMINATION OF THE DEVICE CONFIRMED THAT THE TIP HAD BROKEN 1 CM DOWN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 40 MINUTES INTO A MENINGIOMA TUMOR REMOVAL, THE STERILE ULTRASONIC ASPIRATOR TIP BROKE AND A 1 CM LONG FRAGMENT FELL INTO THE SURGICAL SITE. THE TIP FRAGMENT WAS EASILY SEEN AND THE SURGEON REMOVED THE FRAGMENT WITH FORCEPS. A BACKUP TIP WAS USED TO COMPLETE THE PROCEDURE, WITHOUT CAUSING A CLINICALLY SIGNIFICANT DELAY. THE PT DID NOT REQUIRE ANY ADDITIONAL MEDICAL TREATMENT DUE TO THIS EVENT. THERE WAS NO PT OR USER INJURY REPORTED, AND NO OTHER ADVERSE CONSEQUENCES ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 25KHZ SPETZLER BARACUDA TIP INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK