BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18384286 · Received December 22, 2023

    Report

    Report Number
    2955842-2023-21674
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    June 23, 2017
    Report Date
    November 29, 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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED. NO PRODUCTS HAVE BEEN RETURNED TO INTUITIVE SURGICAL, INC. FOR EVALUATION. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE COULD NOT BE COMPLETED, AS NO ONSITE CONNECTION WAS AVAILABLE ON THE REPORTED EVENT DATE.

    Description of Event or Problem · 0

    PER INFORMATION RECEIVED FROM A PATIENT OF AN ALLEGED DA VINCI-ASSISTED SIGMOID AND UPPER RECTAL RESECTION PROCEDURE, THE SURGEON REMOVED TOO LITTLE INTESTINAL TISSUE WHEN CREATING AN ANASTOMOSIS FOLLOWING THE RESECTION OF AN INTESTINAL OBSTRUCTION. THE PATIENT ALLEGED THAT THE TISSUE AT THE LOCATION OF THE ANASTOMOSIS WAS NECROTIC. FOLLOWING THE PROCEDURE, THE PATIENT WENT INTO SEVERE SEPTIC SHOCK, AND THEY WERE SUBSEQUENTLY RESUSCITATED. SEVERAL EMERGENCY OPERATIONS FOLLOWED, INCLUDING A STAGED LAVAGE, THE CREATION OF AN ARTIFICIAL BOWEL OUTLET (HARTMANN'S PROCEDURE) AND, A YEAR LATER, THE REPOSITIONING OF THE ARTIFICIAL BOWEL OUTLET. THE PATIENT ALSO UNDERWENT SEVERAL HERNIA OPERATIONS AFTERWARDS, AS A RESULT OF THIS ISSUE. THE PATIENT ALLEGED THAT THE SURGEON REQUIRED 8 HOURS TO COMPLETE THE PROCEDURE, RATHER THAN THE STANDARD 2 HOURS. THEY FURTHER ALLEGED THAT THE OPERATION WAS KNOWINGLY UNSUCCESSFUL WHEN IT WAS COMPLETED, YET NOTHING WAS DONE TO CORRECT THE MATTER. ON THE CONTRARY, INSTEAD OF REPAIRING THE DAMAGE WITH AN IMMEDIATE FOLLOW-UP OPERATION, THE PATIENT WAS TRANSFERRED TO A NORMAL WARD OVERNIGHT AND WAS, THEREFORE, NOT EVEN IN INTENSIVE CARE. THE SURGEON WAS UNABLE TO VERIFY IF THE PROCEDURE WAS PERFORMED VIA A DA VINCI SYSTEM OR VIA A TRANSENTERIX SYSTEM, DUE TO THE EXTENDED LENGTH OF TIME THAT HAS ELAPSED FROM THE TIME OF THE SURGERY TO NOW. AT THAT TIME, IN 2017, THERE WAS NO ONSITE CONNECTION AVAILABLE; PER THE AVAILABLE DOCUMENTATION, THE ONLY DA VINCI-ASSISTED PROCEDURES PERFORMED ON THE ALLEGED EVENT DATE WERE PROSTATECTOMIES. THE SURGEON WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611272 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES