BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISTOOL

    MDR report key: 5053612 · Received September 3, 2015

    Report

    Report Number
    0001831750-2015-00415
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 7, 2015
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BRAKE WILL NOT ENGAGE. 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
    586505 SURGISTOOL STOOL, OPERATING-ROOM FZM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1