BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCHPOINT INFINITY

    MDR report key: 6910415 · Received October 3, 2017

    Report

    Report Number
    6910415
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    June 1, 2016
    Report Date
    September 29, 2017
    Manufacturer
    STRYKER COMMUNICATIONS INC.
    Product Code
    OCS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STRYKER IS USING A VERY POOR QUALITY DVI CONNECTOR FOR THEIR VIDEO INTEGRATION SYSTEM. THIS TYPE OF CONNECTOR KEEPS BREAKING VERY OFTEN, ALMOST WEEKLY. THEY ARE USING A DVI CONNECTOR THAT IS NOT INTENDED TO BE USED FOR THE AMOUNT OF MECHANICAL WORK THAT IT IS USED FOR. WE HAVE 13 OPERATING ROOMS IN OUR FACILITY AND WE REPLACE THIS CONNECTOR ALMOST WEEKLY. THEY BREAK BECAUSE THEY CANNOT WITHSTAND THE WEIGHT OF THE CABLES THAT ARE USED AND ALSO THE AMOUNT OF TIMES THAT THE DVI CONNECTOR NEEDS TO BE USED ON THE DAILY BASIS. MANUFACTURER RESPONSE FOR VIDEO INTEGRATION SYSTEM, (PER SITE REPORTER): THEY HAVE REPLACED THE CONNECTOR MULTIPLE TIMES, BUT HAVEN'T COME UP WITH A SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690555 SWITCHPOINT INFINITY ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY OCS STRYKER COMMUNICATIONS INC. 0678001000

    Patients

    Seq Age Sex Outcome Treatment
    1