BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3953919 · Received July 23, 2014

    Report

    Report Number
    2955842-2014-04507
    Event Type
    Other
    Date Received
    July 23, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SITE'S RISK MANAGER, THE PATIENT'S INJURY TO THE ILIAC VEIN WAS CAUSED BY SURGEON USER-ERROR. THE RISK MANAGER INDICATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM CAUSED/CONTRIBUTED TO THE PATIENT'S INJURY. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SACROCOLPOPEXY PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES AFTER THE PATIENT'S ILIAC VEIN WAS INJURED. HOWEVER, ACCORDING TO THE SITE'S RISK MANAGER, THE PATIENT'S INJURY WAS CAUSED BY SURGEON USER-ERROR AND NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SACROCOLPOPEXY PROCEDURE, THE SURGEON NICKED THE ILIAC VEIN AND THE PATIENT RECEIVED 6 LITERS OF BLOOD. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON HAD TO UNDOCK THE DA VINCI SURGICAL SYSTEM FROM THE PATIENT AND CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES. THE PATIENT WAS GIVEN BLOOD AND ANOTHER SURGEON WAS CALLED IN TO ASSIST WITH THE SURGICAL PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER STATED THAT HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, HE STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(4) 2014, ISI ALSO CONTACTED A ROBOTICS COORDINATOR FROM THE SITE. THE ROBOTICS COORDINATOR STATED THAT THE INJURY TO THE PATIENT'S ILIAC VEIN WAS CAUSED BY SURGEON USER-ERROR. SHE INDICATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE OR CAUSED/CONTRIBUTED TO THE PATIENT'S ILIAC VEIN INJURY. THE PATIENT WAS GIVEN SEVERAL UNITS OF BLOOD AND THE OPEN SURGICAL PROCEDURE WAS COMPLETED. THE PATIENT WAS TAKEN TO THE ICU AND DISCHARGED FROM THE HOSPITAL ON AN UNSPECIFIED DATE. ACCORDING TO THE ROBOTICS COORDINATOR, NO POST-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431151 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention