BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, CONNECTED OR HUB BASE SYSTEM

    MDR report key: 17926114 · Received October 12, 2023

    Report

    Report Number
    0002936485-2023-01045
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 14, 2023
    Report Date
    July 15, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    07613327413281
    PMA / PMN Number
    K222079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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: FLICKERING IMAGE. 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 [COR, IP], CLARITY PACKAGE, CLARITY ALGORITHM, USE ERROR , CYBERSECURITY , ESP SOFTWARE [ESP]. THE REPORTED 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 FLICKERING IMAGE AND LOSS OF IMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FLICKERING IMAGE AND LOSS OF IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133179 PKG, CONNECTED OR HUB BASE SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE 07613327413281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown