BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, PRECISION LED LIGHT SOURCE

    MDR report key: 17999557 · Received October 24, 2023

    Report

    Report Number
    0002936485-2023-01073
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    October 5, 2023
    Report Date
    July 1, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FCW
    UDI-DI
    07613327051322
    PMA / PMN Number
    K082813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: THIS PRECISION MALFUNCTION WHILE STEALTH NAVIGATION WAS ACTIVATED DURING AN ENT CASE. [UPDATE - THE MALFUNCTION OCCURRED NEAR THE END OF THE CASE. AFTER REBOOTING THE CONSOLE, THE SURGICAL TEAM WAS UNABLE TO GET THE LIGHT SOURCE TO REACTIVATE. THE SURGEON WAS ABLE TO FINISH WITHOUT USING THE LIGHT SOURCE AS THE REST WAS CLOSURE OF THE INCISION. IT WASN¿T UNTIL I REMOVED IT FROM THE ROOM TO TROUBLESHOOT THAT IT REACTIVATED WITH ITS NORMAL WHITE COLORED LIGHT. AT THIS POINT I POWER CYCLED IT SEVERAL TIMES AND OBSERVED NO ABNORMAL FUNCTION. THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. ALTHOUGH THE COMPLAINT COULD NOT BE CONFIRMED, THE PROBABLE ROOT CAUSE COULD BE ONE OF THE LED CLIPS ON THE MAIN BOARD BECOMING OPEN AND/OR THE LED MODULE NEEDING CALIBRATION. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237362 PKG, PRECISION LED LIGHT SOURCE LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW STRYKER ENDOSCOPY-SAN JOSE 07613327051322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown