BEUDAMED
    FDA Adverse Event Summary report: N

    4085 SURGICAL TABLE

    MDR report key: 5732362 · Received June 17, 2016

    Report

    Report Number
    1043572-2016-00054
    Date Received
    June 17, 2016
    Date of Event
    May 19, 2016
    Report Date
    June 17, 2016
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE REPORTED EVENT THE TABLE WAS REMOVED FROM SERVICE AND STERIS SERVICE WAS CONTACTED. A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND THAT THE HYDRAULIC FLUID WAS LOW. THE TECHNICIAN OBSERVED A SMALL AMOUNT OF HYDRAULIC FLUID ON THE TABLE BASE AROUND AND UNDER THE RESERVOIR. THE TECHNICIAN WAS UNABLE TO IDENTIFY ANY SIGNS OF A HYDRAULIC FLUID LEAK. THE TECHNICIAN FILLED THE RESERVOIR WITH HYDRAULIC FLUID TO THE PROPER LEVEL AND CLEANED ANY VISIBLE OIL FROM THE TABLE BASE. THE REPORTED STRUGGLE OF THE TABLE WHEN COMMANDED INTO POSITION WOULD BE DUE TO THE LOW HYDRAULIC FLUID OBSERVED BY THE TECHNICIAN. USER FACILITY PERSONNEL WERE NOT FOLLOWING PROPER OPERATING PROCEDURES DURING THE TIME OF THE EVENT FOR THE SURGICAL TABLE AS STATED IN THE OPERATOR MANUAL. THE OPERATOR MANUAL STATES (PP. 1-3), "WITH PATIENT IN NORMAL OR REVERSE ORIENTATION, TABLE IN TRENDELENBURG AND SLIDE AT HEAD LIMIT, CENTER TABLETOP BEFORE ATTEMPTING TO RAISE TABLE TO LEVEL OR MOVE INTO REVERSE TRENDELENBURG." THE TABLE WAS FOUND TO BE OPERATING PROPERLY AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE SURGICAL TABLE AND IS AWAITING A RESPONSE.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DECLINED STERIS' OFFER OF IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE SURGICAL TABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TABLE STRUGGLED INTO THE COMMANDED POSITION AND THE TABLE BEGAN TO TIP. USER FACILITY PERSONNEL WERE ABLE TO PLACE THE TABLE INTO THE DESIRED POSITION AND THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY HOWEVER, A PROCEDURAL DELAY OCCURRED DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388428 4085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1