BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG 1688 AIM 4K CAMERA HEAD C-MOUNT

    MDR report key: 22878054 · Received August 22, 2025

    Report

    Report Number
    0002936485-2025-00727
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 31, 2025
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    07613327418989
    PMA / PMN Number
    K182160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 DEVICE WAS RECEIVED AT THE LOCAL SERVICE FACILITY FOR INVESTIGATION. THE TECHNICAL SERVICE REPORT INDICATES: PROBLEM DESCRIPTION (SYMPTOM): IMAGE CLARITY NOT GOOD. ACTION TAKEN AT SITE (DIAGNOSIS): CHECKED AND DONE GENERAL SERVICE. CLEANED THE CAMERA LENS AND ADJUSTED SETTINGS. FINAL REPORT: UNIT IS WORKING FINE. JOB COMPLETED: YES. 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. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN IMAGE CLARITY ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN IMAGE CLARITY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619093 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