BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3920879 · Received July 8, 2014

    Report

    Report Number
    2955842-2014-04172
    Event Type
    Other
    Date Received
    July 8, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOCUS CONTROLLER HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE DEVICE IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: DUE TO THE ALLEGED ISSUE WITH THE FOCUS CONTROLLER THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROCEDURE TO AN OPEN PROCEDURE.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FOCUS CONTROLLER INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED THE INITIAL REPORTER'S COMPLAINT. AN IN-HOUSE TESTING WAS DONE BY PERFORMING A VISUAL INSPECTION AND IT WAS VERIFIED THAT THE CAMERA CONNECTOR WAS BROKEN. THE FOCUS CONTROLLER WAS REPAIRED BY REPLACING THE CAMERA INTERFACE ADAPTER (CIA) BOARD. THE FOCUS CONTROLLER PASSED A SYSTEM TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON WALKED INTO THE OPERATING ROOM TO PERFORM A DA VINCI PROSTATECTOMY PROCEDURE, HE NOTICED THAT THE FOCUS CONTROLLER CONNECTOR TO THE CAMERA CABLE WAS BENT AND THE PINS WERE BROKEN. THE SURGEON INDICATED THAT HE THOUGHT THAT THE CAMERA CABLE WAS DAMAGE-FREE; HOWEVER, HE WAS NOT SURE SINCE HE COULD NOT TEST IT. THE FOCUS DID NOT WORK AT ALL AND THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROCEDURE TO AN OPEN PROCEDURE, SINCE THE PATIENT WAS ALREADY UNDER ANESTHESIA. ON (B)(6) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND NOTICED THAT THE CONNECTION OF THE LEFT AND RIGHT CAMERA CABLES WERE REVERSED AT THE BACK OF THE CHARGE-COUPLE DEVICE (CCD). THE FOCUS CONTROLLER WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION AND A NEW CAMERA CABLE WAS INSTALLED ON THE SYSTEM. ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION: THE SYSTEM WAS TESTED PRIOR TO USE AND NO PROBLEMS WERE NOTED DURING SET-UP. THE SURGEON NOTICED AN ISSUE WITH THE FOCUS WHEN CALIBRATING THE 0° OPTICS. HE USUALLY CHECKS THE CLEARNESS BEFORE CALIBRATING. THE PATIENT WAS UNDER ANESTHESIA FOR ABOUT 20 MINUTES AND ONLY THE SUPRAUMBILICAL INCISION AND CO2 INSUFFLATION HAD BEEN DONE. THE PATIENT TOLERATED THE OPEN PROCEDURE AND WAS DISCHARGED ON JULY 4, 2014. THE SURGEON FELT THAT THE REASON WHY THE CABLE WAS BENT AND THE PINS WERE BROKEN WAS THAT THE PLUG MAY HAVE NOT BE FULLY PUSHED IN. HE CLAIMS THERE WAS A GAP (DISTANCE) BETWEEN THE PLUG AND THE FOCUS MODULE WHICH RESULTED IN THE BREAKING OF THE PINS. THE LEFT AND RIGHT CAMERA CABLES AND FOCUS WERE MAINTAINED AT THE HANDLE/GRIP OF THE COLUMN BY A VELCRO FASTENER WHICH SLIDES ALONG THE HANDLE/GRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398294 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other