BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L9000 LIGHTSOURCE INTERNATIONAL KIT

    MDR report key: 7287585 · Received February 21, 2018

    Report

    Report Number
    0002936485-2018-00158
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    January 8, 2018
    Report Date
    May 18, 2018
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FCW
    PMA / PMN Number
    K082813
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION AT STRYKER ENDOSCOPY BECAUSE IT WAS REPAIRED LOCALLY IN DUBLIN, IRELAND; THEREFORE THE REPORTED FAILURE CANNOT BE CONFIRMED. THE TECHNICAL SERVICE REPORT IS ATTACHED (SEE COMMUNICATION LOG), AND INDICATES: FAULT: E2 ERROR. THE REPORTED EVENT INVOLVING THIS FAILURE AND DEVICE COULD HAVE BEEN CAUSED BY: LIGHT CABLE; OPTICS; LEDS; MAIN BOARD; JAW ASSEMBLY; BENT ESST CONTACT; INCONSISTENT ESST CONTACT; CABLE PULL OUT; CAMERA HEAD; FIREWIRE CABLE; SOFTWARE; FRONT BOARD; POWER SUPPLY; THERMAL SWITCH; AC INLET BOARD; AND/OR USE ERRORS. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED AT STRYKER ENDOSCOPY FOR INVESTIGATION THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. GTIN: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LIGHT SOURCE STOPPED WORKING DURING A CASE. THE PROCEDURE WAS CONVERTED TO OPEN PROCEDURE AND COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. MFG DATE:THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT SOURCE STOPPED WORKING DURING A CASE. THE PROCEDURE WAS CONVERTED TO OPEN PROCEDURE AND COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131010 L9000 LIGHTSOURCE INTERNATIONAL KIT LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other