BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOPET

    MDR report key: 2112999 · Received May 29, 2011

    Report

    Report Number
    2112999
    Event Type
    Malfunction
    Date Received
    May 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    May 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER INITIAL SUCCESSFUL IRRIGATION AND TESTING OF SONOPET UNIT/HANDPIECE, THE SONOPET UNIT FAILED UPON ACTIVATION BY SURGEON. UNIT TAKEN OFF LINE AND REPLACED WITH STRYKER UNIT AND A 3.2 MM BURR. SURGERY COMPLETED SUCCESSFULLY AFTER THAT, WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONOPET SURGICAL ASPIRATOR, ULTRASONIC LFL STRYKER INSTRUMENTS UST2001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR