BEUDAMED
    FDA Adverse Event Other Summary report: N

    3080 SP SURGICAL TABLE

    MDR report key: 855483 · Received May 22, 2007

    Report

    Report Number
    1043572-2007-00014
    Event Type
    Other
    Date Received
    May 22, 2007
    Date of Event
    March 20, 2007
    Report Date
    May 22, 2007
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3080 RL SURGICAL TABLE PRODUCT COMPLETED A 15,600 CYCLE (10 YEAR EQUIVALENT) LIFECYCLE/RELIABILITY TEST UNDER CONDITIONS OF GREATER THAN AVERAGE LOADING PRIOR TO PRODUCT LAUNCH; THE TABLE INVOLVED IN THE INCIDENT WAS 11 YEARS OLD. THIS MODEL TABLE WAS THE SUBJECT OF A 2007 OBSOLESCENCE NOTICE TO CUSTOMERS WHICH STATED THAT STERIS COULD NO LONGER FULLY SUPPORT THE TABLE BECAUSE THE HYDRAULICS SUB-SUPPLIER STOPPED PRODUCTION, MAKING CRITICAL REPLACEMENT PARTS UNAVAILABLE. THE USER FACILITY DECLINED STERIS' OFFER FOR AN IN-SERVICE TRAINING.

    Additional Manufacturer Narrative · 1

    IN 2007, STERIS RECEIVED A CALL FROM MOUNT AUBURN HOSPITAL REGARDING A SURGICAL TABLE THAT ALLEGEDLY STARTED TO MOVE FROM A TRENDELENBERG TO REVERSE TRENDELENBURG POSITION DURING A SURGICAL PROCEDURE. STERIS SENT A TECH TO THE HOSPITAL TO INSPECT THE TABLE. THE SVC TECH REPORTED THAT THE 11-YEAR OLD TABLE IS IN FAIR CONDITION, AND IS MAINTAINED BY THE HOSPITAL'S BIOMEDICAL DEPT. THE TECH DID NOT FIND ANY PROBLEMS WITH THE ARTICULATION OF THE TABLE. THE TECH ALSO INSPECTED THE TABLE'S HIGH PRESSURE HOSES, OIL LEVEL, TABLE COLUMN SWITCH, OVERRIDE SWITCHES, HAND CONTROL BATTERY VOLTAGES, AND FOOT CONTROL. THE TECH WAS UNABLE TO DUPLICATE THE REPORTED SITUATION. ON APRIL 24, 2007, THE TECH RETURNED TO THE HOSPITAL, AND AT THE REQUEST OF THE HOSPITAL AND REPLACED THE FLOOR LOCKS, LUBRICATED THE LOCK HOUSINGS AND COLUMN, AND REPLACED A MISSING SET SCREW. AFTER REPAIRING THE TABLE, THE TECH RETURNED IT TO THE FACILITY. DURING THE SECOND VISIT, THE TECH NOTICED THAT THE PROTECTIVE OVERRIDE COVER FOR THE TABLE HAD RECENTLY BEEN REPLACED. A BROKEN COVER WOULD HAVE LEFT THE OVERRIDE SWITCHES EXPOSED AND VULNERABLE TO ACTIVATION BY LOOSE ITEMS SUCH AS A CABLE OR A SHEET. THE TRENDELENBERG/REVERSE TRENDELENBERG SWITCH IS ONE OF THE OUTERMOST SWITCHES, AND WOULD HAVE BEEN VULNERABLE TO ACCIDENTAL ACTIVATION IN SUCH AN INSTANCE. THE STERIS ACCOUNT MGR ASSIGNED TO THE HOSPITAL HAS AGREED TO PROVIDE ADD'L IN-SVC TRAINING TO HOSPITAL STAFF ON AN AS-NEEDED BASIS.

    Description of Event or Problem · 1

    PT IN OPERATING ROOM UNDERGOING A PROCEDURE WHEN OPERATING TABLE STARTED TO MOVE FROM TRENDELENBERG POSITION TO REVERSE TRENDELENBERG POSITION. ANESTHESIA STATED CONTROL MECHANISM WAS NOT WORKING PROPERLY. SURGEON UNABLE TO SEE THE TIP OF UROCELLERATOR BLADE AS THE TABLE CONTINUED TO MOVE. WHEN TABLE RETURNED TO TRENDELENBERG, THE SURGEON NOTED A SUPERFICIAL LACERATION OF THE RETROSIGMOID. NO REPAIR WAS NEEDED. PROCEDURE: EXAM UNDER ANESTHESIA, LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 264 MG/DL, 24 MG/DL, AND 117 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3080 SP SURGICAL TABLE SURGICAL TABLES AND ACCESSORIES FQO STERIS CORPORATION - MONTGOMERY 2175655 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR