BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 17358274 · Received July 20, 2023

    Report

    Report Number
    2955842-2023-17171
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 23, 2023
    Report Date
    June 23, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INVERTED IMAGE AND NON-INTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE REVIEWED THE SURGICAL VIDEO, AND NOTED THAT THE VIDEO WAS NOT ROTATED WHEN IT WAS FLIPPED UPSIDE DOWN. THE FSE DETERMINED THAT THE ROTATION OF THE ENDOSCOPE WAS INHIBITED. FSE FURTHER CONFIRMED THROUGH THE CUSTOMER THAT THE IMAGE DISPLAY ISSUE WAS CORRECTED AFTER PHYSICALLY REMOVING THE BLOCKAGE OR OBSTRUCTION. FSE REPRODUCED THE REPORTED EVENT. FOLLOWING THIS, THE SYSTEM WAS RETESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    ON 25-JUL-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE REPORTED EVENT: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY TRANSTHORACIC NECK ANASTOMOSIS PROCEDURE, ALL THE INSTRUMENTS AND ENDOSCOPE WERE OBSERVED TO MOVE IN THE OPPOSITE DIRECTION. THE ISSUE OCCURRED AFTER THE SURGEON SELECTED ¿UP¿ TO SWITCH FROM THE ¿DOWN¿ FUNCTION OF THE ENDOSCOPE BY USING THE SSC TOUCHPAD, RESULTING IN THE MOVEMENT OF THE 30-DEGREE ENDOSCOPE BECOMING THE OPPOSITE OF ¿UP¿ AND ¿DOWN¿, ¿LEFT¿ AND ¿RIGHT¿. THE INTENDED DIRECTION WAS FOR THE INSTRUMENT TO MOVE AWAY FROM THE LUNG TISSUE AND TOWARD THE CEILING, AND THE OBSERVED MOTION WAS THAT THE INSTRUMENT MOVED CLOSER TO THE LUNG TISSUE. BLEEDING WAS OBSERVED FROM THE LUNG TISSUE OR FROM THE INFERIOR PULMONARY VEIN DURING MANIPULATION IN THE SUPERIOR MEDIASTINUM. THE BLOOD LOSS AMOUNT IS UNKNOWN. THE SURGEON BELIEVES THE BLEEDING WAS DUE TO PRESSURE THAT WAS PLACED ON THE TISSUE BY THE SYNCHROSEAL INSTRUMENT. BLEEDING WAS EXPECTED TO OCCUR DURING THE PROCEDURE; A BLOOD TRANSFUSION WAS NOT REQUIRED. NO ADDITIONAL INTERVENTION WAS REQUIRED TO RESOLVE THE BLEEDING. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LIVE LOGS AND DID NOT FIND ANY RELATED ERRORS. TROUBLESHOOTING WAS RECOMMENDED TO MANUALLY ROTATE THE BASE OF THE 30-DEGREE ENDOSCOPE TO CONFIRM MOTION, RESEAT THE SCOPE PLUG TO THE VISION SIDE CART (VSE), AND PERFORM A POWER CYCLE. HOWEVER, DUE TO EXPERIENCING THIS ISSUE FOR THE FIRST TIME, THE SURGEON MADE THE CLINICAL DECISION TO CONVERT TO LAPAROSCOPY AND TO TROUBLESHOOT AFTER THE PROCEDURE. NO INCREASE IN PORT INCISION SIZE WAS MADE. THE PATIENT TOLERATED THE CONVERSION. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE SURGEON¿S HEAD WAS INSIDE THE SURGEON SIDE CONSOLE (SSC) HIGH RESOLUTION STEREO VIEWER (HRSV) AT THE TIME. THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR ARM-TO-ARM INTERFERENCE. NO SHAKINESS OR FRICTION WAS OBSERVED. THERE WAS NO SERIOUS DETERIORATION OR CLINICAL INSTABILITY DURING THE TIME IT TOOK TO GET AND INSTALL A BACK-UP INSTRUMENT. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE IMAGE DISPLAYED WAS CORRECTED DUE TO THE ENDOSCOPE ROTATION BEING PHYSICALLY BLOCKED. REVIEW OF THE SYSTEM LOG WAS PERFORMED, AND THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS WERE OBSERVED: * ERROR CODE: 23 - WHEEL HARDWARE FAULT: MSC REPORTED A HARDWARE FAULT IN THE WHEEL COMMUNICATION. POINTING TO REAR CORE FIBER PORT (TOP PORT). * ERROR CODE: 40084 - A COMM LINK FROM THE MSC IN ICC IS DOWN. MESSAGE DESTINATION WAS SCC2 IN CONSOLE2 GCC. * ERROR CODE: 40 - GBIT HARDWARE FAULT: THE MSC NODE ON ICC REPORTED A GBIT COMMUNICATION ERROR ON GBIT INSTANCE 0 (CORE: TOP BLUE FIBER PORT, MASTER, LEFT VIDEO AND COMM). * ERROR CODE: 25724 - UCE DSPNET ERROR ON MCER IN RAC2 IN SSC1. A FOLLOWING WHEEL TRANSMIT ROUTINE HAS FAILED. * ERROR CODE: 25720 - THE MCEL ON RAC1 IN SURGEON'S CONSOLE 1 HAS REPORTED THAT FOLLOWING DATA IS BAD OR MISSING ON THE MTML ARMNET. * ERROR CODE: 41014 - THE PCC3 NODE IN UCC REPORTED THAT A SUPERVISOR TO MSC QUEUE OVERFLOWED. * ERROR CODE: 40241 - DATA SOURCED FROM PCC3 IN UCC DESTINED TO PCTP IN UMC1 CAUSED CTP QUEUING FAULT. * ERROR CODE: 25714 - MCER (RAC2) IN SSC1 IS REPORTING THE POSITION LOOP (PLOOP) IS TAKING LONGER THAN EXPECTED TO RUN ON MTMR. * ERROR CODE: 25328 - THE CTP REPORTED THAT AN OPERATION WAS ATTEMPTED BEFORE THE MSC WAS FULLY INITIALIZED. REVIEW OF THE ADVANCED SYSTEM LOG WAS PERFORMED AND THERE IS NOTHING TO SUGGEST FAULT WITH THE SYSTEM. THE LOGS FROM BEFORE AND AFTER THE PROCEDURE WERE ALSO REVIEWED, AND THERE HAVE BEEN NO OTHER EVENTS THAT WOULD SUGGEST SYSTEM FAULTS RELATED TO THE REPORTED EVENT. EVERYTHING THAT FOLLOWED THE SYSTEM POWERING DOWN (CODE 55101) WAS INTENTIONALLY EXCLUDED. AFTER THE DECISION WAS MADE TO CONVERT TO LAPAROSCOPIC, THE SYSTEM WAS NOT SHUT DOWN PROPERLY AND THE PROCEDURE WAS NOT OFFICIALLY ENDED. THIS IS WHY THE HUMAN-READABLE SECTION FOR CODE 55201 (END OF PROCEDURE) NOTES THAT THE PROCEDURE AUTOMATICALLY ENDED DUE TO THE SYSTEM BEING OFF FOR AN EXTENDED PERIOD OF TIME. THESE ADDITIONAL ERRORS OCCURRED AFTER THE PROCEDURE HAD BEEN CONVERTED TO LAPAROSCOPIC, SO THE INITIAL REVIEW IS STILL ACCURATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY TRANSTHORACIC NECK ANASTOMOSIS SURGICAL PROCEDURE, THE USER OBSERVED THAT ALL OF THE INSTRUMENTS THE SURGEON HAD SELECTED "UP" ON THE ENDOSCOPE. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SERVICE ENGINEER (TSE). TSE REVIEWED THE LOGS AND DID NOT FIND ANY RELATED ERRORS. THE USER WAS ADVISED TO TROUBLESHOOT BY MANUALLY ROTATING THE BASE OF THE ENDOSCOPE TO CONFIRM MOTION, RESEAT THE ENDOSCOPE PLUG ON THE VISION SIDE CART (VSC), AND PERFORM A POWER CYCLE IF NEEDED. NO TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER ELECTED TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DECISION TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY WAS DUE TO THE SURGEON EXPERIENCING THE REPORTED COMPLAINT FOR THE FIRST TIME. THERE WAS NO INCREASE IN SURGICAL PORT SIZE. THE PATIENT TOLERATED THE CHANGE OF PROCEDURE WELL WITH NO PATIENT INJURY OR HARM. THE PATIENT DID NOT EXPERIENCE ANY POST OPERATIVE COMPLICATIONS. THE REPORTED EVENT OCCURRED WHILE THE SURGEONS HEAD WAS INSIDE THE SURGEON SIDE CONSOLE (SSC) HIGH RESOLUTION STEREO VIEWER (HRSV). WHEN THE REPORTED ISSUE OCCURRED THE SURGEON WAS SWITCHING BETWEEN THE UP AND DOWN FUNCTIONS OF THE ENDOSCOPE BY USING THE SSC TOUCHPAD. THE INTENDED DIRECTION WAS FOR THE INSTRUMENTS TO MOVE AWAY FROM THE LUNG TISSUE AND TOWARD THE CEILING, AND THE OBSERVED MOTION WAS THAT THE INSTRUMENT MOVED CLOSER TO THE LUNG TISSUE. THERE WAS NO SHAKINESS OR FRICTION OBSERVED. THERE WAS NO INSTRUMENT TO INSTRUMENT OR ARM TO ARM INTERFERENCE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839545 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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