BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, FLEXIBLE CONTROL UNIT

    MDR report key: 5298964 · Received December 15, 2015

    Report

    Report Number
    0002936485-2015-01117
    Event Type
    Malfunction
    Date Received
    December 15, 2015
    Date of Event
    November 20, 2015
    Report Date
    November 20, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FGB
    PMA / PMN Number
    K121112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: CABLES, CONNECTORS, DIGITAL BOARD, POWER SUPPLY, AC INLET BOARD, MAIN BOARD, TRANSITION BOARD, SOFTWARE, ARTICULATING SCOPE, PACKAGING, LOOSE/TIGHT SOAKER CAP, POWER TO ARTICULATING SCOPE, FCU CONNECTOR, FCU VIDEO CONNECTORS, USE ERROR. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.¿¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGE WENT OUT IN THE MIDDLE OF A CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGE WENT OUT IN THE MIDDLE OF A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825964 PKG, FLEXIBLE CONTROL UNIT URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FGB STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability