BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3971774 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04649
    Event Type
    Other
    Date Received
    July 31, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 20, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS ARE BEING RETURNED BACK FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2014 AND CONFIRMED THE SYSTEM ERROR CODE 814 WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO THE REPORTED SYSTEM ERROR CODE 814, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROCEDURE TO OPEN SURGICAL TECHNIQUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR CODE 814 A NON-RECOVERABLE FAULT, WHICH IS A PATIENT SIDE CART (PSC) LEFT BRAKE ERROR. THE SITE TRIED SEVERAL HARD RESETS AND DROVE THE CART BACK AND FORTH; HOWEVER, THE ERROR CODE 814 PERSISTED. DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROCEDURE TO OPEN SURGICAL TECHNIQUES. AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) VISITED THE SITE THE SAME DAY AND NOTICED THAT THE LEFT BRAKE CABLE WAS PINCHED. ONCE THE CABLE WAS UNPINCHED THE ROBOT WORKED FINE. THE FSE REPLACED THE BRAKE CABLE AND THE FLUID INTRUSION GUIDE AND THE REPORTED ISSUE WAS RESOLVED. ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION: THE SYSTEM WAS TESTED PRIOR TO USE WITH NO SYSTEM MALFUNCTION REPORTED DURING THE SETUP OF THE SYSTEM. AT THIS TIME IT IS UNKNOWN HOW LONG THE DA VINCI SURGICAL PROCEDURE WAS IN PROGRESS WHEN THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO AN OPEN SURGERY. IT IS UNKNOWN HOW THE PATIENT TOLERATED THE OPEN PROCEDURE OR WHEN THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448602 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS 3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other