BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISTOOL

    MDR report key: 3731741 · Received April 7, 2014

    Report

    Report Number
    0001831750-2014-02861
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 11, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WOULD NOT ENGAGE DUE TO A DAMAGED BRAKE ASSEMBLY AND THERE WAS INADEQUATE BRAKE FORCE DUE TO A WORN BRAKE TIP. 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
    208754 SURGISTOOL STOOL, OPERATING-ROOM FZM FZM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1