BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3319403 · Received August 30, 2013

    Report

    Report Number
    2955842-2013-03315
    Event Type
    Other
    Date Received
    August 30, 2013
    Date of Event
    November 28, 2005
    Report Date
    August 1, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2005. NO VISION RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT THE DA VINCI PROSTATECTOMY PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES AFTER THE PATIENT SUSTAINED AN INJURY TO A VESSEL AND THE SURGEON ENCOUNTERED A CAMERA MALFUNCTION. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE REPORTED VESSEL INJURY.

    Description of Event or Problem · 1

    AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO WAS PLANNED FOR A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2005, THAT WAS CONVERTED AND COMPLETED BY OPEN SURGICAL TECHNIQUES. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON STATED THAT AT THE TIME AN INCISION WAS MADE IN THE PLEXUS, A LARGE BLEEDER OCCURRED. THE SURGEON WAS ABLE TO STOP THE BLEEDING WITH THE ROBOT BY APPLYING PRESSURE ON THE VESSEL WITH ONE OF THE ROBOTIC INSTRUMENTS. DURING REPAIR AND SUTURING OF THE VESSEL, THE SURGEON INDICATED THAT THE CAMERA MALFUNCTIONED. FOR APPROXIMATELY 20 MINUTES, THE SURGICAL STAFF ATTEMPTED TO TROUBLESHOOT THE CAMERA ISSUE BUT IT WAS NOT SUCCESSFUL. AS A RESULT OF THE CAMERA ISSUE AND NOT BEING ABLE SEE WHERE TO ADEQUATELY TIE A SUTURE, THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES. THE PATIENT'S ABDOMEN WAS OPENED FROM THE UMBILICUS DOWN TO THE SYMPHYSIS. AFTER THE DAMAGED VESSEL WAS REPAIRED WITH A 2-0 VICRYL SUTURE, THE SURGEON NOTED THAT ALL FURTHER BLEEDING STOPPED. THE SURGEON THEN REMOVED THE PATIENT'S PROSTATE BY CUTTING THE URETHRA. UPON COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) DUE TO A TOTAL BLOOD LOSS OF 2700 ML. THE SURGEON STATED IN THE OPERATIVE REPORT THAT THE ESTIMATED BLOOD LOSS AT THE POINT OF CONVERTING THE CASE TO OPEN SURGICAL TECHNIQUES WAS 500 ML. HOWEVER, AT THE END OF THE SURGERY, ONCE THE CO2 PRESSURE WAS RELEASED, THE ESTIMATED BLOOD LOSS WAS ABOUT 2700 ML. ON (B)(6) 2005, THE PATIENT'S JACKSON-PRATT DRAIN WAS REMOVED. THE PATIENT WAS TOLERATING A REGULAR DIET AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428536 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE