BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISTOOL

    MDR report key: 3717978 · Received April 1, 2014

    Report

    Report Number
    0001831750-2014-02833
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BRAKE TIP IS MISSING WHICH WILL EFFECT THE BRAKING FUNCTION OF THE STOOL. 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
    193604 SURGISTOOL STOOL, OPERATING-ROOM FZM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1