BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG CONNECTED OR HUB BASE SYSTEM

    MDR report key: 22925143 · Received August 29, 2025

    Report

    Report Number
    0002936485-2025-00740
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    May 14, 2024
    Report Date
    September 11, 2025
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    07613327413281
    PMA / PMN Number
    K222079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: OVERHEATING CONFIRMED FAILURE: DAMAGED CHASSIS TOP/LID REPLACED CHASSIS COVER FAILURE TO REMOVE PHI/PATIENT DATA UPGRADED SOFTWARE APPLICATION FREEZES/STOPS RESPONDING APPLICATION FREEZES/STOPS RESPONDING HUB TIER 2 REPAIR PROBABLE ROOT CAUSE: ¿ FAN(S) FAILURE ¿ AIR DUCT FAILURE ¿ POWER SUPPLY FAILURE ¿ TEMPERATURE SENSOR FAILURE ¿ FIRMWARE/SOFTWARE FAILURE - NO/INCORRECT TEMPERATURE SENSING THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: OVERHEATING. CONFIRMED FAILURE: DAMAGED CHASSIS TOP/LID. REPLACED CHASSIS COVER. FAILURE TO REMOVE PHI/PATIENT DATA. UPGRADED SOFTWARE. APPLICATION FREEZES/STOPS RESPONDING. APPLICATION FREEZES/STOPS RESPONDING. HUB TIER 2 REPAIR. PROBABLE ROOT CAUSE: FAN(S) FAILURE. AIR DUCT FAILURE. POWER SUPPLY FAILURE. TEMPERATURE SENSOR FAILURE. FIRMWARE/SOFTWARE FAILURE: NO/INCORRECT TEMPERATURE SENSING. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE OVERHEATED. THEREFORE, THERE WAS A THERMAL EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE OVERHEATED. THEREFORE, THERE WAS A THERMAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2879448 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