BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISTOOL

    MDR report key: 3881373 · Received June 18, 2014

    Report

    Report Number
    0001831750-2014-03088
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE BRAKES WERE ALLEGED TO NOT BE WORKING PROPERLY. NO PATIENT WAS AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357684 SURGISTOOL STOOL, OPERATING-ROOM FZM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1