BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKG L9000 LIGHT SOURCE

    MDR report key: 8555764 · Received April 26, 2019

    Report

    Report Number
    0002936485-2019-00163
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    April 1, 2019
    Report Date
    June 20, 2019
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FCW
    UDI-DI
    07613327051339
    PMA / PMN Number
    K082813
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 DEVICE WAS NOT RECEIVED FOR INVESTIGATION AT STRYKER ENDOSCOPY BECAUSE IT WAS REPAIRED LOCALLY IN STRYKER INDIA; 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. THE TECHNICAL SERVICE REPORT IS ATTACHED (SEE COMM LOG), AND INDICATES: TOUCH PANEL & SWITCH NOT WORKING. PROBABLE ROOT CAUSE: - FRONT BOARD - U10 FAILURE - TOUCH SCREEN - MAIN BOARD - JAW ASSEMBLY - POWER SUPPLY - LEDS - TILTING - LIGHT PIPE - FANS - AC INLET BOARD - AC INLET FILTER - BUTTON ROD - CHASSIS - WORKMANSHIP - INADEQUATE AIR FLOW - INADEQUATE CALIBRATION - USE ERRORS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE HAD TO BE CONVERTED TO OPEN PROCEDURE.

    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 PROCEDURE HAD TO BE CONVERTED TO OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349750 PKG L9000 LIGHT SOURCE LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW STRYKER ENDOSCOPY-SAN JOSE 07613327051339

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other