BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 16968005 · Received May 19, 2023

    Report

    Report Number
    2955842-2023-13754
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    April 26, 2023
    Report Date
    April 26, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND FOUND TO TRIGGER ERROR 31226 ON THE IN-HOUSE SYSTEM. THE COMPLAINT REGARDING REPEATED ERRORS WAS CONFIRMED BASED OF FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE WAS ATTRIBUTED TO FAULTY ELECTRONIC COMPONENTS.

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPEATED ERRORS. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE USM. THE SYSTEM WAS THEN TESTED AND VERIFIED AS READY FOR USE. BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM), BUT THE FAILURE ANALYSIS INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS RECEIVED. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SYSTEM HAD REPEATED ERRORS THAT LOCKED UP THE SYSTEM. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY AND HAND ASSIST. THERE WERE EXTRA PORTS PLACED ON THE PATIENT AND ONE PORT INCISION WAS INCREASED IN SIZE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT ERRORS WERE REOCCURRING REPEATEDLY. THE SYSTEM LOGS CONFIRMED MULTIPLE REOCCURRENCES OF MOTOR AXIS AND COMMUNICATION LINK ERRORS REPORTED BY THE AXES CONTROLLER MOTOR (ACM) AND AXES CONTROLLER SPAR (ACS) IN THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE PROCEDURE WAS CONTINUED, AND IT WAS INITIALLY INDICATED THAT THE PROCEDURE WAS COMPLETING AS PLANNED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC COORDINATOR STATED THE SAME ERROR KEPT REOCCURRING AND LOCKING UP THE SYSTEM. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC AND HAND ASSIST. THERE WERE EXTRA PORTS PLACED AND ONE PORT WAS INCREASED TO 2 INCHES. THE PATIENT WAS ABLE TO TOLERATE THE CONVERSION. THE SURGEON HAD PLANNED ON USING THE SYSTEM AND DID NOT ANTICIPATE CONVERTING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005935 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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