BEUDAMED
    FDA Adverse Event Summary report: N

    3080SP SURGICAL TABLE

    MDR report key: 2834251 · Received November 15, 2012

    Report

    Report Number
    1043572-2012-00094
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 15, 2012
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND OVER SEVERAL HOURS OF TESTING WAS ABLE TO DUPLICATE THE REPORTED EVENT. THE TECHNICIAN PROVIDED THE USER FACILITY WITH A LIST OF RECOMMENDED PARTS WHICH HE DETERMINED NEEDED TO BE REPLACED. THE USER FACILITY CONTACTED THE TECHNICIAN AND STATED THAT THEY WILL NOT BE REPAIRING THE TABLE AND DO NOT INTEND ON PLACING IT BACK INTO SERVICE. THE TABLE WAS MANUFACTURED IN 1994 AND HAS BEEN IN USE FOR APPROXIMATELY 18 YEARS. THE USER RECOGNIZES THE TABLE HAS MET ITS USEFUL LIFE. STERIS RECOMMENDED TO THE USER THAT IF NOT REPAIRED THE TABLE MUST PROPERLY BE DISPOSED OF.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A ROBOTIC-ASSISTED PATIENT PROCEDURE THE TABLE BEGAN TO MOVE WITHOUT BEING COMMANDED TO DO SO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A MINIMAL DELAY AND NO INJURIES TO HOSPITAL STAFF OR PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3080SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1