BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT

    MDR report key: 20213762 · Received September 13, 2024

    Report

    Report Number
    0002936485-2024-00647
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 30, 2024
    Report Date
    December 11, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    PMA / PMN Number
    K182160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATE TO G4 "PMA/510(K)" FROM K222079 TO K182160. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: NO VIDEO OUTPUT 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 USE ERROR THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAMERA CONSOLE DID NOT TURN ON. NO INCISIONS HAD BEEN MADE AND THE MEDICAL PROCEDURE WAS CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAMERA CONSOLE DID NOT TURN ON. NO INCISIONS HAD BEEN MADE AND THE MEDICAL PROCEDURE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535992 1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown