BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, 1488 HD 3-CHIP CAMERA HEAD, C-MOUNT

    MDR report key: 16342759 · Received February 9, 2023

    Report

    Report Number
    0002936485-2023-00111
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 23, 2023
    Report Date
    August 24, 2023
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    07613327061055
    PMA / PMN Number
    K132785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: BLURRY GRAINY IMAGE. CONFIRMED FAILURE: CHD-A-LCJ LOOSE CABLE JACKET PROBABLE ROOT CAUSE: ¿ CABLES ¿ CONNECTORS ¿ DIGITAL BOARD ¿ POWER SUPPLY ¿ FILTER / FUSE ¿ AC INLET BOARD ¿ MAIN BOARD ¿ TRANSITION BOARD ¿ FIBER BOARD ¿ INTERMITTENCE BETWEEN TRANSITION BOARD AND CH CONNECTOR ¿ SOFTWARE ¿SCOPE (SEE RSK10356 OUTPUT ""VISUALIZATION/IMAGE"") ¿LIGHT SOURCE (SEE RSK10975 OUTPUT ""WHITE LIGHT"") ¿ CAMERA HEAD (SENSOR, SENSOR CABLE) ¿ COUPLER (DUST ON OPTICS, SCRATCHED OPTICS, BROKEN / SHIFTED LENSES, FOCUSING MECHANISM, ENDOCLAMP, ZOOM RING) ¿ 1488 & 1588 EXTENSION CABLE ¿ INTERMITTENCE WHILE USING RF DEVICES (EX: VALLEYLAB) ¿ PROBLEM TOGGLING LIGHT SOURCE OR FROM CAMERA HEAD ¿ CONNECTED MONITORS ¿ LEAKING ¿ USE ERROR ¿ POOR GROUNDING (E.G. ""FINGER"" GROUNDING TAB CONNECTING FRONT AND REAR ENCLOSURE. CAMERA HEAD CONNECTION FROM CABLE TO TRANSITION BOARD.) ¿ELECTROMAGNETIC INTERFERENCE (EMI) FROM RF COMMUNICATION, HF SURGICAL INSTRUMENTS, ESD, OR POWER SURGE ¿ MANUFACTURING/ SERVICE NONCONFORMITY" THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    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
    1067742 PKG, 1488 HD 3-CHIP CAMERA HEAD, C-MOUNT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE 1488210105 07613327061055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown