BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25KHZ STRAIGHT TIP

    MDR report key: 3042736 · Received April 9, 2013

    Report

    Report Number
    0001811755-2013-00727
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 26, 2013
    Report Date
    November 12, 2013
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND EVALUATED. (B)(4): NOT YET RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NO LONGER AVAILABLE FOR EVALUATION. NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEBULKING OF AN ACOUSTIC NEUROMA, THE TIP OF THE SONOPET GENERATED HEAT. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO SMOKE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE; THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEBULKING OF AN ACOUSTIC NEUROMA, THE TIP OF THE SONOPET GENERATED HEAT. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO SMOKE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE; THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145589 25KHZ STRAIGHT TIP INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI 0162580

    Patients

    Seq Age Sex Outcome Treatment
    1