BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 14068877 · Received April 9, 2022

    Report

    Report Number
    2955842-2022-10983
    Event Type
    Malfunction
    Date Received
    April 9, 2022
    Date of Event
    March 10, 2022
    Report Date
    March 10, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE CUSTOMER PROVIDED THE FSE WITH TWO 30-DEGREE ENDOSCOPES AND TWO CAMERA HEADS FOR TROUBLESHOOTING. FSE CONFIRMED THAT THERE WAS AN INTENSE DARK SHADE OR VIGNETTE EFFECT WHEN LOOKING THROUGH THE RIGHT LENS. THE DUAL CAMERA CONTROL UNIT (DOCO) WAS REPLACED AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPLICATED. THE DOCO WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE UNIT WAS CONFIGURED, AND CALIBRATED. THE SYSTEM STARTED UP WITHOUT ANY ERROR. THE PICTURE IS SHARP AND CLEAR ON BOTH EYES. THERE WAS NO SHADE NOR VIGNETTING ISSUE OBSERVED. TESTS WERE ALSO PERFORMED WITH 0 AND 30DEGREE SCOPES. THE SYSTEM RAN 20 POWER CYCLES WITH THE RETURNED DOCO AND ALL PASSED WITH GOOD PICTURES ON BOTH LEFT AND RIGHT EYES. THE PART REMAINED ON THE TEST SYSTEM OVER TWO DAYS IN NORMAL OPERATION, AND THERE WAS NO ERROR, NOR ANY ANOMALIES FOUND. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TECHNICAL SUPPORT ENGINEER (TSE). INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. LOG REVIEW ALSO CONFIRMED THE PROCEDURE DATE OF (B)(6) 2022 AND PROCEDURE TYPE OF GASTRIC BYPASS (ROUX-EN-Y) USING SYSTEM SHE2110. NO IMAGE OR VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: THE SURGEON ELECTED TO CONTINUE WITH THE PROCEDURE WITH ONE OF THE EYE OF THE SYSTEM BEING INTENSELY DARK. THE DOCO WAS SUBSEQUENTLY REPLACED AFTER THE PROCEDURE COMPLETION. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, CUSTOMER HAD A RECURRING ISSUE OF THE IMAGE BEING DARK AT ITS LEFT SIDE. CUSTOMER REPLACED THE CAMERA HEAD, THE CAMERA CABLE, LIGHT GUIDE, HAVE TRIED FOUR DIFFERENT ENDOSCOPES WITH MULTIPLE CALIBRATION, HOWEVER, THE ISSUE REMAINED UNCHANGED. THE CUSTOMER CHECKED THE VIDEO INPUTS AND THE LEFT EYE APPEARED BETTER, BUT THE DEFAULT RIGHT EYE VIDEO LOOKED VERY BAD. THE CUSTOMER STATED THAT THEY HAVE TWO SI SYSTEMS, AND THE OTHER SYSTEM DID NOT HAVE THIS ISSUE THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. THE PATIENT-RELATED INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156842 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-11 N/A 00886874110874

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES