BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKO

    MDR report key: 15093989 · Received July 25, 2022

    Report

    Report Number
    15093989
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    April 12, 2022
    Report Date
    April 18, 2022
    Manufacturer
    STRYKER CORP.
    Product Code
    OJP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MAKO ROBOT NOT WORKING. PATIENT DIDN¿T GET IN TO OPERATING ROOM UNTIL LATER. MANUFACTURER RESPONSE FOR ROBOTIC SURGICAL ARM SYSTEM, (BRAND NOT PROVIDED) (PER SITE REPORTER). TALKED WITH THE REP FROM THE COMPANY. HE SAID THE WERE ABLE TO OPEN UP THE BOOM AND FOUND SOME KINKED WIRES, THEY UNKINKED AND PUT BACK TOGETHER. MONITOR IS NOW WORKING GREAT. UNIT IS BACK IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680456 MAKO ORTHOPEDIC STEREOTAXIC INSTRUMENT OJP STRYKER CORP. MAKO

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown