BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMAX SURGICAL TABLE

    MDR report key: 7135189 · Received December 20, 2017

    Report

    Report Number
    1043572-2017-00083
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    October 2, 2017
    Report Date
    December 20, 2017
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING RECEIPT OF THE MEDWATCH A STERIS SERVICE TECHNICIAN WAS DISPATCHED TO THE USER FACILITY TO INSPECT THE SURGICAL TABLE. USER FACILITY PERSONNEL STATED TO THE STERIS SERVICE TECHNICIAN THAT DURING A ROBOTIC PROCEDURE A LARGE AMOUNT OF FLUID SPILLED ON TO THE TABLE WHICH SUBSEQUENTLY CAUSED FLUID TO ENTER THE TABLE'S INTERIOR. THIS CAUSED DAMAGE TO COMPONENTS AND THE TABLE TO GO INTO REVERSE FLEX POSITION. DURING THE TIME OF THE EVENT, USER FACILITY PERSONNEL WERE UTILIZING A "HEAD BUTLER" WITH THE TABLE. THIS TABLE ACCESSORY IS NOT MANUFACTURED BY STERIS HOWEVER, THE ACCESSORY IS MANUFACTURED TO FIT ALL STANDARD OR TABLES. THE HEAD BUTLER MOUNTS TO THE SURGICAL TABLE'S SIDE RAIL AND PROTECTS PATIENTS FROM ROBOTICS ARMS. DUE TO THE FLUID SPILL AND THE TABLE GOING INTO REVERSE FLEX POSITION, THE HEAD BUTLER ACCESSORY MADE CONTACT WITH THE PATIENT. THE ACCESSORY WAS REMOVED AND THE PATIENT WAS TRANSFERRED. THE CMAX SURGICAL TABLE WAS MANUFACTURED IN 2009 AND IS SERVICED AND MAINTAINED BY THE USER FACILITY'S BIOMEDICAL DEPARTMENT. STERIS HAS NOT PERFORMED SERVICE ON THE CMAX SURGICAL TABLE SINCE 2010. THE OPERATOR MANUAL STATES (PP. 5-11), "WHENEVER THE TABLE COLUMN COVER ASSEMBLY AND/OR TABLE BASE COVER ARE REMOVED AND THEN RETURNED, THE COVERS NEED SEALED TO PREVENT FLUID INTRUSION TO MEET IPX4 REQUIREMENTS." WHEN THE STERIS TECHNICIAN ARRIVED ONSITE THE BASE COVERS WERE REMOVED AND THE TABLE REMAINED OUT OF SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED VIA MW5072951 THAT THEIR CMAX SURGICAL TABLE TILTED DURING THE CONCLUSION OF A PATIENT PROCEDURE. THE PATIENT WAS TRANSFERRED TO ANOTHER TABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915918 CMAX SURGICAL TABLE SURGICAL TABLE GDC STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1