BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 17796174 · Received September 22, 2023

    Report

    Report Number
    2955842-2023-18648
    Event Type
    Death
    Date Received
    September 22, 2023
    Date of Event
    August 15, 2023
    Report Date
    August 22, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATIONS CANNOT BE DETERMINED. A REVIEW OF THE SYSTEM LOGS FOR THIS PROCEDURE FOUND THAT THERE WERE NO RELEVANT ERRORS THAT OCCURRED DURING THE SURGICAL PROCEDURE. AT THE TIME OF REVIEW, ONE SUBSEQUENT PROCEDURE HAD BEEN PERFORMED WITH THE SYSTEM WITH NO RELEVANT ERRORS FOUND. A REVIEW OF THE DEVICE LOGS FOR THE INSTRUMENTS USED DURING THE REPORTED PROCEDURE WAS CONDUCTED. THE ENDOSCOPE AND ALL OF THE MULTI-USE INSTRUMENTS USED IN THE PROCEDURE WERE USED IN SUBSEQUENT PROCEDURES. A SITE HISTORY REVIEW SHOWS NO COMPLAINTS HAVE BEEN FILED AGAINST ANY OF THE INSTRUMENTS OR THE ENDOSCOPE. A DEVICE HISTORY RECORD (DHR) REVIEW FOUND THAT THERE WERE NO NON-CONFORMANCES IDENTIFIED TO BE RELATED TO THIS COMPLAINT. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT THE PATIENT IN THIS SUMMARY DIED OF COMPLICATIONS RELATED TO A BOWEL PERFORATION. THE INITIAL OPERATION WAS COMPLETED WITH NO ISSUES DETECTED AT THE TIME OF THE INITIAL SURGERY. THE INJURY WAS DISCOVERED ON EXPLORATION THE NEXT DAY FOLLOWING THE INITIAL OPERATION. THE HOSPITAL HAS SPECULATED THAT PORT PLACEMENT WAS THE MECHANISM OF INJURY. THE PATIENT DIED DURING THE RE-EXPLORATION. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL DESPITE SEVERAL ATTEMPTS TO GAIN ADDITIONAL INFORMATION FROM MULTIPLE SOURCES. BASED ON THE DETAILS PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION EXISTS TO ASCERTAIN IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DAY AFTER A DA VINCI-ASSISTED PYELOPLASTY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED A BOWEL INJURY THAT REQUIRED A SECOND SURGERY TO REPAIR, DURING WHICH THE PATIENT EXPIRED. THE HOSPITAL CHIEF OF ROBOTICS INFORMED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) ABOUT THE BOWEL INJURY AND PATIENT DEATH AND STATED THAT IT MAY HAVE OCCURRED DURING AN INSTRUMENT EXCHANGE. THE CHIEF OF ROBOTICS DID NOT PROVIDE ANY INFORMATION REGARDING IF THE PATIENT HAD ANY COMPLICATIONS DURING THE FIRST OR SECOND PROCEDURE, OR EXPIRED INTRA-OPERATIVELY, POST-OPERATIVELY. ATTEMPTS TO SPEAK WITH THE SURGEON WERE NOT SUCCESSFUL. ADDITIONAL FOLLOW-UP INFORMATION WITH THE ISI CSR CLARIFIED THAT THE CHIEF OF ROBOTICS HAD SPECULATED THAT THE PATIENT¿S BOWEL INJURY MAY HAVE OCCURRED DURING AN INSTRUMENT EXCHANGE. THE CSR ALSO SPOKE WITH THE ROBOTICS COORDINATOR, WHO WAS NOT PRESENT DURING THE PROCEDURE. ANOTHER POSSIBILITY WAS PROPOSED BY THE ROBOTICS COORDINATOR WHO SUGGESTED A PORT INJURY WAS THE MOST LIKELY SOURCE OF INJURY. IT WAS CONFIRMED THAT THE CHIEF OF PEDIATRIC UROLOGY BROUGHT THE PATIENT BACK TO THE OPERATING ROOM THE FOLLOWING DAY FOR BOWEL SURGERY, WHERE THE PATIENT CODED ON THE TABLE AND THEN EXPIRED. INTUITIVE SURGICAL FOLLOW-UP BY THE ISI MEDICAL SAFETY OFFICER DIRECTLY WITH THE ROBOTICS COORDINATOR CONFIRMED THAT SHE WAS ONLY PRESENT AT THE BEGINNING OF THE ROBOTIC PROCEDURE AND STATED THAT SHE HEARD THE PROCEDURE WENT SMOOTHLY WITH NO COMPLICATIONS NOTED AT THE TIME. ANOTHER POSSIBILITY WAS PROPOSED BY THE ROBOTICS COORDINATOR WHO SUGGESTED THAT A PORT INJURY WAS THE MOST LIKELY SOURCE OF INJURY. REGARDING THE POST-OPERATIVE EVENTS, THE ROBOTICS COORDINATOR WAS ONLY AWARE THAT THEY CAME BACK TO THE OPERATING ROOM THE NEXT DAY AND THE PATIENT EXPIRED INTRA-OPERATIVELY. NO FURTHER INFORMATION WAS AVAILABLE. THE ISI MEDICAL SAFETY OFFICER ALSO FOLLOWED-UP DIRECTLY WITH THE ROBOTIC PHYSICIAN ASSISTANT (PA) WHO REPORTED THAT THERE WERE 3 DAVINCI ROBOTIC PORTS AND ONE [3RD PARTY] AIRSEAL PORT. WHEN ASKED WHERE THE PORTS WERE PLACED, THE ROBOTICS COORDINATOR WAS NOT ENTIRELY SURE BUT THOUGHT THE AIRSEAL WAS PLACED IN THE RIGHT SIDE. SHE MADE NO COMMENT ON THE LOCATION OF DAVINCI ROBOTIC PORTS. THE PA CONFIRMED THAT THE PROCEDURE ¿WENT FINE¿. THE PA STATED THAT DURING THE SECOND SURGERY THE SURGEON IDENTIFIED A SMALL BOWEL INJURY. THE PA STATED THAT SHE HAD HEARD THAT THE BOWEL INJURY WAS IN THE TERMINAL ILEUM BUT WAS NOT SURE. THE SITE RISK MANAGEMENT WAS ALSO CONTACTED FOR FURTHER INFORMATION; HOWEVER, DECLINED TO CONFIRM OR DISCUSS THE REPORTED DETAILS. THE RISK MANAGER STATED THAT ¿INTUITIVE SURGICAL DID NOT HAVE ANY INVOLVEMENT WITH THIS PARTICULAR CASE¿ AND REQUESTED THAT NO FURTHER CONTACT BE MADE TO THE HOSPITAL SITE. THE ISI CSR SUBSEQUENTLY ALSO INFORMED THE ISI MEDICAL SAFETY OFFICER THAT THE PRIMARY HOSPITAL HAS SHUT DOWN ON DISCUSSING THIS CASE ANY FURTHER. HE STATED THAT THE CONCERN MOST PEOPLE SEEM TO HAVE WAS OF A POSSIBLE PORT INJURY THAT WAS UNDETECTED AT THE TIME OF THE INITIAL SURGERY. THE PREVIOUS REPORT OF A POTENTIAL INSTRUMENT SWAP AS THE SOURCE OF INJURY WAS AN ADDITIONAL SPECULATIVE SUGGESTION MADE BY THE ROBOTICS DIRECTOR, BUT HE WAS NOT PRESENT AT THE CASE AND THERE WAS NO ADDITIONAL INFORMATION KNOWN TO THE CSR REGARDING THIS SPECULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501969 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.