BEUDAMED
    FDA Adverse Event Summary report: N

    UROSKOP ACCESS

    MDR report key: 3843827 · Received May 28, 2014

    Report

    Report Number
    2240869-2014-04039
    Date Received
    May 28, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OWB
    PMA / PMN Number
    K010942
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR MANUAL FOR THE UROSKOP ACCESS SYSTEM (SPL5-330.620.02.02.02) CONTAINS SEVERAL CAUTIONS ON HOW TO AVOID COLLISION SUCH AS TO "OPERATE THE SYSTEM ONLY UNDER VISUAL CONTACT" AND "BEFORE INITIATING MOVEMENTS, MAKE SURE THAT NO OBSTRUCTIONS ARE PRESENT. IT ALSO STATES THAT: "THE MONITOR SUPPORT SYSTEM, MONITOR CART AND ACCESSORIES (E.G. TABLE EXTENSION) ARE NOT DETECTED BY THE COLLISION MONITORING SYSTEM". SIEMENS ENGINEER HAD TO REPLACE THE LIFT MODULE TO BRING THE UNIT BACK TO SPECIFICATIONS. THE SYSTEM IS FULLY OPERATIONAL. THIS REPORT WAS SUBMITTED MAY 23, 2014.

    Description of Event or Problem · 1

    SIEMENS SERVICE ENGINEER REPORTED THAT THE CUSTOMER HAD DRIVEN THE TUBE SUPPORT ARM OF THE UROSKOP ACCESS SYSTEM INTO THE OVERHEAD ASSEMBLY. THE OVERHEAD ASSEMBLY IS A MOVEABLE "BOOM" THAT THE MONITORS ATTACHED FOR ENDOSCOPY MONITORING (NO SIEMENS DEVICE). THE INCIDENT OCCURRED WHEN THE OPERATOR WAS POSITIONING THE TABLE FOR THE PATIENT TRANSFER. THERE WAS NO PATIENT IN THE EXAM ROOM WHEN THE INCIDENT OCCURRED. THE OPERATOR BY MISTAKE BROUGHT THE OVERHEAD ASSEMBLY INTO THE COLLISION ZONE. THE UROSKOP ACCESS DOES NOT HAVE A COLLISION PROTECTION FOR THIS, SO THE SYSTEM WAS NOT ABLE TO PREVENT THE COLLISION. THE UROSKOP ACCESS SYSTEM STOPPED FUNCTIONING DUE TO THE EXCESSIVE CURRENT DRAW AT THE TIME OF COLLISION. THERE WERE NO INJURIES ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314171 UROSKOP ACCESS IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY OWB SIEMENS MEDICAL SOLUTIONS USA, INC. 05756122 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other