BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIVERSAL HANDPIECE

    MDR report key: 3757918 · Received April 17, 2014

    Report

    Report Number
    0001811755-2014-01379
    Event Type
    Death
    Date Received
    April 17, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION WAS REPORTED ON THIS DEVICE AND IT WAS NOT RETURNED. NO FAILURES WERE FOUND WITH THIS DEVICE AS THE PRODUCT FOR THIS INVESTIGATION WAS NOT AVAILABLE FOR EVALUATION. THE PATIENT SUFFERED FROM CARDIAC ARREST, AND THE REASON THE PATIENT EXPIRED WAS CONFIRMED TO BE BLOOD LOSS.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY HAS DISCARDED THE TIPS AND THE TUBING THAT WERE USED IN THIS CASE, AND HAS ELECTED NOT TO RETURN THE UNIVERSAL HANDPIECE AND CONSOLE 110V FOR A QUALITY INVESTIGATION. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, AS WELL AS THE RELATED DEVICES. A FOLLOW UP REPORT WILL BE FILED WHEN NEW INFORMATION IS RECEIVED. NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A CARDIAC ARREST DURING A CRANIOTOMY TUMOR REMOVAL.   IT WAS REPORTED THAT THE SONOPET SYSTEM WAS BEING USED DURING THIS PROCEDURE, BUT WAS NOT IN USE AT THE TIME THE CARDIAC ARREST OCCURRED.  THE OPERATING ROOM STAFF ATTEMPTED TO MANUALLY PUMP THE HEART FOR 15 MINUTES, BUT WAS UNABLE TO REVIVE THE PATIENT.  IT WAS LATER CONFIRMED THAT THE PATIENT EXPIRED DUE TO BLOOD LOSS.  THERE WAS NO REPORT OF A PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A CARDIAC ARREST DURING A CRANIOTOMY TUMOR REMOVAL.   IT WAS REPORTED THAT THE SONOPET SYSTEM WAS BEING USED DURING THIS PROCEDURE, BUT WAS NOT IN USE AT THE TIME THE CARDIAC ARREST OCCURRED.  THE OPERATING ROOM STAFF ATTEMPTED TO MANUALLY PUMP THE HEART FOR 15 MINUTES, BUT WAS UNABLE TO REVIVE THE PATIENT.  IT WAS LATER CONFIRMED THAT THE PATIENT EXPIRED DUE TO BLOOD LOSS.  THERE WAS NO REPORT OF A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234985 UNIVERSAL HANDPIECE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death M102 TIP SETP/N: 5450800413| DISP. TUBE SETP/N: 5450850003| 25KHZ SPTZLR BAR LG DIA TIPP/N: 5450800306| CONSOLE 110VP/N: 5450850000