BEUDAMED
    FDA Adverse Event Death Summary report: N

    3080 RL SURGICAL TABLE

    MDR report key: 1640820 · Received March 25, 2010

    Report

    Report Number
    1043572-2010-00015
    Event Type
    Death
    Date Received
    March 25, 2010
    Date of Event
    February 24, 2010
    Report Date
    March 25, 2010
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS COMPLETED IN-SERVICE TRAINING FOR HOSPITAL STAFF REGARDING THE PROPER USE AND OPERATION OF THE TABLE, AS WELL AS, THE WARNINGS CONTAINED WITHIN THE LABELING OF THE TABLE. STERIS OFFERED THE USER FACILITY ADDITIONAL TRAINING FOR BIOMEDICAL PERSONNEL REGARDING THE PROPER MAINTENANCE OF THE TABLE, HOWEVER THE USER FACILITY DECLINED.

    Additional Manufacturer Narrative · 1

    THE WEIGHT LIMIT FOR THE SURGICAL TABLE INVOLVED IN THE EVENT IS 400 POUNDS. ACCORDING TO A FACILITY BIOMEDICAL TECHNICIAN, THE PATIENT INVOLVED IN THE EVENT WEIGHED (B) (6). A WARNING LABEL ON THE TABLE REINFORCES THE IMPORTANCE OF THE FOLLOWING INSTRUCTION IN THE TABLE'S OPERATOR MANUAL: "DO NOT USE THIS TABLE FOR PATIENTS EXCEEDING THE 400-POUND LIMIT. THE MAXIMUM SAFE PATIENT WEIGHT ON THIS TABLE FOR STANDARD SURGICAL POSITIONS IS 400 POUNDS WITH FLOOR LOCKS ENGAGED. OBESE PATIENTS MAY CAUSE TIPPING IF REVERSED ON THIS TABLE". THE FACILITY ALSO REPORTED USING HEAD REST EXTENSIONS ON BOTH ENDS OF THE TABLE AS WELL AS THIRD-PARTY OUTRIGGERS IN ORDER TO ACCOMMODATE THE PATIENT'S SIZE (DESPITE AN INSTRUCTION IN THE OPERATOR MANUAL AGAINST EXTENDING THE LENGTH OF THE TABLE DUE TO A TIPPING HAZARD). THE FACILITY REPORTED THAT THE PATIENT'S EXTREME SIZE AND ORIENTATION OBSTRUCTED ACCESS TO THE TABLE'S AUXILIARY OVERRIDE SWITCHES AT THE TIME OF THE EVENT. THE TABLE INVOLVED IN THE INCIDENT WAS 18 YEARS OLD. THE FACILITY BIOMEDICAL MAINTENANCE DEPARTMENT, WHICH SERVICED AND MAINTAINED THE TABLE PRIOR TO THE EVENT, REPORTED THAT THE ANNUAL PREVENTIVE MAINTENANCE ON THE TABLE WAS APPROXIMATELY FIVE MONTHS PAST DUE. IN ADDITION, 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. A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND IT TO BE IN PROPER MECHANICAL CONDITION. THE INSPECTION ALSO REVEALED THE FOLLOWING: (1) THE TOP OF THE COLUMN SHROUD WAS SLIGHTLY SEPARATED; (2) TWO SCREWS WERE MISSING THAT HOLD THE BOTTOM SHROUD TOGETHER; (3) THE ROLL PIN OF THE KIDNEY BRIDGE GUIDE WAS OUT OF PLACE; AND (4) THE HYDRAULIC LINE WAS COMPRESSED WHEN THE TABLE WAS PLACED IN THE LOWERED POSITION. THE USER FACILITY HAS REPLACED THE MISSING SCREWS, REPAIRED THE HYDRAULIC LINE, AND REPOSITIONED THE ROLL PIN. STERIS'S INVESTIGATION SUGGESTS THAT THE CAUSE OF THE EVENT WAS USER ERROR IN FAILING TO OBSERVE OPERATOR INSTRUCTIONS, PARTICULARLY THOSE RELATING TO PATIENT WEIGHT AND POSITIONING GUIDELINES. STERIS HAS SCHEDULED IN-SERVICE TRAINING ON APRIL 1ST AND 2ND, 2010 FOR HOSPITAL STAFF REGARDING THE PROPER USE AND OPERATION OF THE TABLE, AS WELL AS, THE WARNINGS CONTAINED WITHIN THE LABELING OF THE TABLE. THE FACILITY'S BIOMEDICAL TECHNICIAN WILL ALSO BE PARTICIPATING IN TRAINING ON THE PROPER MAINTENANCE OF THE SURGICAL TABLE ON SITE AT STERIS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A PROCEDURE FOR TREATMENT OF STENOSIS CAUSED BY A MALIGNANT TUMOR, PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE RELEASE PHASE, THERE WAS AN EXPANSION PROBLEM WITH THE STENT. AFTER AN UNKNOWN AMOUNT OF TIME, THE STENT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL COLONIC STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Description of Event or Problem · 1

    (B) (4)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death