BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, 1688 AIM 4K CAMERA HEAD, C-MOUNT

    MDR report key: 17367698 · Received July 20, 2023

    Report

    Report Number
    0002936485-2023-00710
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 23, 2023
    Report Date
    July 25, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    07613327418989
    PMA / PMN Number
    K182160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: FOGGY. CONFIRMED FAILURE: CHD-A-DRE DEFORMED REAR ENCLOSURE . CHD-A-DTH DAMAGED THREADS ON FRONT ENCLOSURE. PROBABLE ROOT CAUSE: CABLES. HDMI CABLES. CONNECTORS. DIGITAL BOARD. POWER SUPPLY. FILTER FUSE. AC INLET BOARD. MAIN BOARD. TRANSITION BOARD. INTERMITTENCE BETWEEN TRANSITION BOARD AND CH CONNECTOR. SOFTWARE. CAMERA HEAD. COUPLER. PROBLEM TOGGLING LIGHT SOURCE. CONNECTED MONITORS. LEAKING. POOR GROUNDING. NO INCORRECT COMMUNICATION WITH LIGHT SOURCE. SOAKING CAP DISCONNECTION DURING STERILIZATION. ELECTROMAGNETIC INTERFERENCE (EMI) FROM RF COMMUNICATION, HF SURGICAL INSTRUMENTS, ESD, OR POWER SURGE. CYBERSECURITY ATTACK. PENDULUM CH INERTIAL MEASUREMENT UNIT (IMU). INCIDENT LIGHT FROM SURGICAL SCENE IS REFLECTED BY COUPLER/CH WINDOW. USE ERROR. 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 THERE WAS FOGGY IMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271528 PKG, 1688 AIM 4K CAMERA HEAD, C-MOUNT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE 1688210105 07613327418989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown