BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1288 CCU WITH FIBER BOARD INTERNATIONAL KIT

    MDR report key: 3951510 · Received July 23, 2014

    Report

    Report Number
    0002936485-2014-00513
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 29, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    PMA / PMN Number
    K983566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1288 CAMERA CONTROL UNIT CATALOG #1288010001 SERIAL NUMBER (B)(4) WAS RETURNED TO STRYKER ENDO FOR INVESTIGATION AND REPORTED FAILURE WAS CONFIRMED. NO PROBLEM DURING VISUAL INSPECTION OF THE CCU: FREE FROM DENTS, SCRATCHES, NO DUST FROM COVER AND CHASSIS. NO UNUSUAL MARKINGS. ON ANALYSIS AND TESTING OF CAMERA CONTROL UNIT (CCU) MODEL 1288 SERIAL NUMBER (B)(4), IT WAS DETERMINED THAT THERE WAS A BROKEN TRACE ON THE FLEX BOARD CAUSING AN E1 ERROR ON THE SCREEN. ON THE SECOND ISSUE: UPON CONSULTATION WITH R&D REGARDING THE BLACK SCREEN, IT WAS FOUND THAT THIS ISSUE IS RELATED TO THE VXP CHIP ON THE DIGITAL BOARD. THE ISSUE WAS REPRODUCED AFTER THE UNIT WAS POWER CYCLED MORE THAN 200 TIMES AND TESTED FOR SEVERAL DAYS. AFTER THE TRANSITION BOARD WAS REPLACED THE CCU WAS INSPECTED AND THE UNIT PASSED ALL THE TESTS. THE CCU HAS THE MOST CURRENT SOFTWARE. ROOT CAUSES: THE FLEX CONNECTOR ON THE TRANSITION BOARD THAT COMMUNICATES TO THE MAIN BOARD HAD A BROKEN TRACE CAUSING AN E1 ERROR. GENUS (VXP) CHIP LOCATED ON THE DIGITAL BOARD SPORADICALLY CAUSES A BLACK SCREEN WHEN STARTING THE CCU. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAMERA SYSTEM SHUT DOWN DURING A CASE. AFTER SHUTTING DOWN THE CONSOLE SHOWED AN ERROR ON THE SCREEN. AFTER THIS OCCURRED THE NURSE TURNED THE CONSOLE OFF AND BACK ON, HOWEVER THE ONLY PICTURE RECEIVED WAS BLACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAMERA SYSTEM SHUT DOWN DURING A CASE. AFTER SHUTTING DOWN THE CONSOLE SHOWED AN ERROR ON THE SCREEN. AFTER THIS OCCURRED THE NURSE TURNED THE CONSOLE OFF AND BACK ON, HOWEVER THE ONLY PICTURE RECEIVED WAS BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432022 1288 CCU WITH FIBER BOARD INTERNATIONAL KIT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1