BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISTOOL

    MDR report key: 3753831 · Received April 16, 2014

    Report

    Report Number
    0001831750-2014-02914
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE NOT STAYING ENGAGED DUE TO A MALFUNCTIONED BRAKE ASSEMBLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232499 SURGISTOOL STOOL, OPERATING-ROOM FZM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1