BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHT SOURCE

    MDR report key: 6015900 · Received October 10, 2016

    Report

    Report Number
    0002936485-2016-00952
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 13, 2016
    Report Date
    February 8, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FCW
    PMA / PMN Number
    K082813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: TOUCH PANEL NOT RESPONDING. PROBABLE ROOT CAUSE: FRONT BOARD, TOUCH SCREEN, MAIN BOARD, POWER SUPPLY, FANS, AC INLET BOARD, BUTTON ROD, USE ERRORS. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE REPORTED SERIAL NUMBER WAS INVALID; THEREFORE THE DEVICE MANUFACTURER DATE COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH PANEL DID NOT WORK DURING SURGERY. SURGICAL DELAY WAS REPORTED. THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT MEDICAL INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH PANEL DID NOT WORK DURING SURGERY. SURGICAL DELAY WAS REPORTED. THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666724 L9000 LIGHT SOURCE LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1