BEUDAMED
    FDA Adverse Event Summary report: N

    4085 SURGICAL TABLE

    MDR report key: 2258392 · Received September 21, 2011

    Report

    Report Number
    1043572-2011-00043
    Date Received
    September 21, 2011
    Date of Event
    August 30, 2011
    Report Date
    September 21, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS ACCOUNT MANAGER AND SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND THAT THE SHROUD WHICH HAD BEEN REMOVED BY FACILITY PERSONNEL WAS DAMAGED. SPECIFICALLY, THE TWO BOTTOM SECTIONS OF THE SHROUD WERE BENT AT THE BOTTOM EDGE, WHICH CAUSED THE SECTIONS TO BIND WHEN THE TABLE WAS COMMANDED TO MOVE DURING THE REPORTED EVENT. THE TECHNICIAN REPLACED THE SHROUDS, TESTED AND RETURNED THE TABLE TO USE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE SURGICAL TABLE SINCE THE REPORTED EVENT. DURING THEIR INVESTIGATION OF THE EVENT, STERIS PERSONNEL IDENTIFIED THAT THE USER FACILITY HAS BEEN USING THE BASE OF THEIR SURGICAL TABLES FOR STORAGE. STORAGE OF ITEMS ON THE TABLE BASE CAN CAUSE BENDING OF THE SHROUD AS EVIDENCED IN THIS EVENT AND IS CONTRAINDICATED IN THE LABELING OF THE TABLE. THE TABLE'S WARNINGS INCLUDE A LABEL ON THE BASE THAT STATES " DO NOT USE TABLE BASE FOR STORAGE." THE OPERATOR MANUAL (PP. 3-1) STATES: " WARNING- PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: DO NOT STORE ITEMS ON TABLE BASE. DOING SO MAY RESULT IN EQUIPMENT DAMAGE OR INADVERTENT TABLETOP MOVEMENT PLACING THE PATIENT AND/OR USER AT RISK OF INJURY." IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE SURGICAL TABLE HAS BEEN SCHEDULED FOR (B)(6) 2011.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A SURGICAL PROCEDURE, HOSPITAL STAFF COMMANDED THE TABLE TO MOVE INTO A TRENDELENBURG POSITION AND HEARD A BINDING SOUND. THE STAFF OBSERVED THAT THE TELESCOPING SHROUD ON THE TABLE EVIDENCED DAMAGE. THEY HAD THE SHROUD REMOVED, POSITIONED THE TABLE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WAS NO INJURY TO HOSPITAL STAFF OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4085 SURGICAL TABLE OPERATING TABLE FQO STERIS CORPORATION - MONTGOMERY 4085

    Patients

    Seq Age Sex Outcome Treatment
    1 Other