BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG CONNECTED OR HUB BASE SYSTEM KIT - INTERNATIONAL

    MDR report key: 19383140 · Received May 23, 2024

    Report

    Report Number
    0002936485-2024-00413
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 30, 2024
    Report Date
    July 31, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    PMA / PMN Number
    K222079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: IMAGE LOST AND RESTARTED. PROBABLE ROOT CAUSE: CABLES, CONNECTORS, SOURCES, OR SINKS; CAPTURE CARD, MOTHERBOARD, POWER SUPPLY; SDC FIRMWARE; OVER-HEATING (AIR DUCT, FANS, HEAT SINKS, DUST, VENTS); SDC APPLICATION SOFTWARE, CLARITY PACKAGE; CLARITY ALGORITHM; USE ERROR; CYBERSECURITY. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219947 PKG CONNECTED OR HUB BASE SYSTEM KIT - INTERNATIONAL LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown