BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18323062 · Received December 13, 2023

    Report

    Report Number
    0002936485-2023-01247
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 17, 2023
    Report Date
    July 2, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    07613327418989
    PMA / PMN Number
    K160332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: POOR QUALITY IMAGE OUTPUT. CONFIRMED FAILURE: CHD-A-CBK - CABLE KINKED; 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 (SENSOR, SENSOR CABLE), COUPLER (DUST ON OPTICS, SCRATCHED OPTICS, BROKEN / SHIFTED LENSES, FOCUSING MECHANISM, ENDOCLAMP, ZOOM RING); PROBLEM TOGGLING LIGHT SOURCE, CONNECTED MONITORS, LEAKING, POOR GROUNDING (E.G CAMERA HEAD CONNECTION FROM CABLE TO TRANSITION BOARD.), 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS PARTIAL IMAGE LOSS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS PARTIAL IMAGE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780432 PKG, 1688 AIM 4K CAMERA HEAD, C-MOUNT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE 07613327418989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown