BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG CONNECTED OR HUB BASE SYSTEM

    MDR report key: 21712419 · Received March 27, 2025

    Report

    Report Number
    0002936485-2025-00248
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 4, 2025
    Report Date
    September 5, 2025
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    07613327601695
    PMA / PMN Number
    K222079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Additional Manufacturer Narrative · 0

    IT WAS CONFIRMED THAT THE DEVICE WILL NOT BE RETURNED. 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: LOSS OF IMAGE. PROBABLE ROOT CAUSE: ¿ CABLES, CONNECTORS, SOURCES, OR SINKS ¿ CAPTURE CARD, MOTHERBOARD, POWER SUPPLY ¿ SDC FIRMWARE ¿ OVER-HEATING ¿ SDC APPLICATION SOFTWARE [COR, IP], 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 NO IMAGE TO THE SYSTEM FROM THE CAMERA, HAD TO WIRE DIRECTLY TO A DISPLAY. THEREFORE, THERE WAS A LOSS OF IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358506 PKG CONNECTED OR HUB BASE SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE 07613327601695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown