BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTIER SURGICAL TABLE

    MDR report key: 2512994 · Received March 28, 2012

    Report

    Report Number
    2031963-2012-00045
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 5, 2012
    Manufacturer
    STRYKER COMMUNICATIONS CORP.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE, NO PT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THE ACTUAL DEVICE WAS EVALUATED IN THE FIELD ON (B)(4) 2012. EVAL SUMMARY ¿ AFTER AN ON-SITE EVAL BY A FIELD SERVICE TECH, IT WAS CONFIRMED THAT THE TABLE WAS LEAKING HYDRAULIC FLUID. IT WAS CONCLUDED THAT THE LEAK WAS COMING FROM THE USIT RING. THE USIT RING IS A WASHER MADE OF TWO MATERIAL, ONE METALLIC AND ONE RUBBER-LIKE MATERIAL (USED FOR SEALING). THE SEALING MATERIAL IS GENERALLY LOCATED ALONG THE INNER DIAMETER OF THE WASHER WHILE THE METAL IS ON THE OUTSIDE. THIS IS ALSO REFERRED TO AS A BONDED SEAL OR U-SEAL. IF THE SEAL IS NOT TORQUED PROPERLY OR THE SEAL IS NOT PROPERLY LUBRICATED PRIOR TO INSTALLATION IT IS POSSIBLE THAT THE SEAL CAN BE DAMAGED CAUSING A LEAK. THERE WAS NO REPORTED PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED. THIS ISSUE WAS RESOLVED BY REPLACING THE USIT WASHERS AND APPLYING THE PROPER TORQUE TO SECURE THE BOLT. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT A SURGICAL TABLE WAS LEAKING HYDRAULIC FLUID FROM ONE OF THE FLOOR CYLINDERS. THERE WAS NO REPORTED PT INVOLVEMENT AND NO REPORT OF ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTIER SURGICAL TABLE FQO STRYKER COMMUNICATIONS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1