BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOPET IQ

    MDR report key: 12711046 · Received October 28, 2021

    Report

    Report Number
    12711046
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    October 11, 2021
    Report Date
    October 20, 2021
    Manufacturer
    STRYKER CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE STRYKER SONOPET ULTRASONIC ASPIRATOR WITH THE SPETZLER CLAW TIP (#5450-800-315) TO TREAT A BONY DEFORMITY FROM AN OLD FRACTURE AND THE PATIENT ENDED UP WITH A BURN ON THE NOSE. SURGEON DISCONTINUED USE OF THE SONOPET ASPIRATOR AND FINISHED TREATMENT WITH THE HAND-HELD RASP. THE NOSE WAS DRESSED AND THE PATIENT WAS DELIVERED TO THE PATIENT ACUTE CARE UNIT WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612342 SONOPET IQ INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER CORPORATION 5500050000

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA Other