BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, 1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER

    MDR report key: 19038318 · Received April 3, 2024

    Report

    Report Number
    0002936485-2024-00293
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 21, 2024
    Report Date
    July 16, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    07613327418996
    PMA / PMN Number
    K182160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 NPF NO PROBLEM FOUND. 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, ENDO CLAMP, 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 BLURRY IMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448496 PKG, 1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE 07613327418996

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown