BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3171060 · Received June 14, 2013

    Report

    Report Number
    2955842-2013-02176
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    ON (B)(4) INTUITIVE SURGICAL INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT THE PATIENT WAS FEMALE AND IN HER LATE TWENTIES. THE PATIENT HAD PELVIC PAIN AND DYSPAREUNIA. SHE UNDERWENT A ROBOTIC LAPAROSCOPY WITH EXCISION OF ENDOMETRIOSIS, LYSIS OF ADHESIONS, AND CHROMOTUBATION. AN EXCISIONAL BIOPSY SHOWED ENDOMETRIOSIS. INTRAOPERATIVELY, THE RIGHT UTEROSACRAL LIGAMENT WAS FOUND TO BE VERY PROMINENT AND BAND-LIKE. THE UTERUS WAS FIXED. THE RIGHT UTEROSACRAL LIGAMENT WAS PARTIALLY TRANSECTED WITH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE SURGEON DENIED THAT THERE WAS A MALFUNCTION OF THE INSTRUMENT OR THE DA VINCI S SURGICAL SYSTEM. ACCORDING TO THE SURGEON, AT THE TIME OF SURGERY, THERE WAS NO APPARENT URETERAL INJURY. THREE TO FOUR WEEKS POST-OPERATIVELY, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND BACK PAIN TO HER PCP. A CT WAS ORDERED AND SHOWED LARGE PELVIC FLUID COLLECTION AND HYDRONEPHROSIS. A UROLOGIST PERFORMED A RETROGRADE PYELOGRAM THAT SHOWED THE INJURY TO THE DISTAL URETER. A PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED. THE SURGEON BELIEVED THAT THE INJURY WAS THERMAL IN NATURE AND DUE TO THERMAL SPREAD OR BY DIRECT CONTACT WITH THE URETER WHILE USING THE MCS INSTRUMENT. THE SURGEON INDICATED, I DON'T BELIEVE IT WAS DUE TO INSTRUMENT FAILURE OR MALFUNCTION.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE RISK MANAGEMENT DEPARTMENT OF THE SITE. THE RISK MANAGEMENT DEPARTMENT WAS UNABLE TO PROVIDE ANY INFORMATION REGARDING THE REPORTED EVENT. INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SURGEON 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. IT IS UNKNOWN WHAT SURGEON ERROR CONTRIBUTED TO THE PATIENT'S URETERAL INJURY. ISI HAS REVIEWED THE SYSTEM LOGS FROM THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013, AND NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON INDICATED THAT THE PATIENT SUSTAINED A URETERAL INJURY THAT WAS DUE TO SURGEON ERROR. HOWEVER, AT THIS TIME, THERE IS NO EVIDENCE OR ALLEGATION THAT A MALFUNCTION OF THE DA VINCI S SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, THE PATIENT SUSTAINED A URETERAL INJURY THAT WAS DUE TO SURGEON ERROR AND NOT AN ISSUE WITH AN INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270794 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES