BEUDAMED
    FDA Adverse Event Other Summary report: N

    TBL COMPONENT, BASIC TABLE WITH SEAT SECTION ONLY

    MDR report key: 1613203 · Received February 8, 2010

    Report

    Report Number
    2031963-2010-00023
    Event Type
    Other
    Date Received
    February 8, 2010
    Date of Event
    October 7, 2008
    Report Date
    November 5, 2008
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTS OF PT INVOLVEMENT. THEREFORE, THIS INFO IS NOT APPLICABLE.: THERE IS NO ESTABLISHED EXPIRATION DATE FOR THIS DEVICE. THE SURGICAL TABLE IS NOT AN IMPLANTABLE DEVICE. THE SURGICAL TABLE IS NOT AN EXPLANTABLE DEVICE. EVAL SUMMARY (CONCLUSION): THE TABLE COLUMN CASE WAS DAMAGED DUE TO THE USER PLACING OBJECTS ON THE BASE OF THE TABLE. THE USER LOWERED THE TABLE ONTO THE OBJECTS, AND THE COLUMN CASE BECAME CAUGHT ON THE OBJECTS, CAUSING DAMAGE. THIS ALSO LED TO THE CUTTING OF THE TRENDELENBERG HYDRAULIC HOSE CREATING A POTENTIAL SAFETY RISK IF THIS WERE TO OCCUR WITH A PT ON THE TABLE. CUTTING OF A HYDRAULIC LINE COULD POTENTIALLY RESULT IN SUBSTANTIAL HYDRAULIC FLUID AND PRESSURE LOSS. THE PRESSURE LOSS FROM THE HYDRAULIC LINE FOR THE RESPECTIVE POSITION WOULD NO LONGER SUPPORT THIS POSITION. THIS COULD LEAD TO THE TABLE QUICKLY MOVING WITHOUT USER INPUT AND CAUSING A POTENTIAL SAFETY RISK TO A PT ON THE TABLE. HOWEVER, IT IS IMPORTANT TO NOTE THAT THERE WAS NO PT INVOLVEMENT, AND THERE WAS ALSO NO REPORT OF ADVERSE CONSEQUENCES AS A RESULT THEREOF. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER, THE BOTTOM TRENDELENBURG HOSE OF THE VERTIER SURGICAL TABLE WAS CUT. THERE WAS NO REPORT OF PT INVOLVEMENT AND NO REPORT OF ADVERSE CONSEQUENCES AS A RESULT THEREOF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL COMPONENT, BASIC TABLE WITH SEAT SECTION ONLY FQO STRYKER COMMUNICATIONS NA 07011924038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA