BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3250892 · Received July 29, 2013

    Report

    Report Number
    2955842-2013-02783
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    April 14, 2011
    Report Date
    June 28, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. (ISI) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE AND 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. ISI HAS REVIEWED THE MEDICAL RECORDS OF THE PATIENT. THE OPERATIVE REPORT OF THE PATIENT FOR (B)(6) 2011, DID NOT REVEAL THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE OPERATIVE REPORT, THE BLADDER FLAP WAS THEN DEVELOPED WITHOUT COMPLICATION, AND DURING THE DEVELOPMENT OF THE LEFT BLADDER FLAP, A DEFECT WAS NOTED. IT WAS FELT THAT WE HAD ENTERED THE VAGINA. AT THIS TIME, WE DECIDED TO CONTINUE THE PROCEDURE AND REPAIR THE VAGINAL DEFECT AT THE COMPLETION OF THE PROCEDURE. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE DA VINCI SI SYSTEM WAS UNDOCKED FROM THE PATIENT. AT THAT POINT, THE SURGEON THEN PROCEEDED TO PERFORM A CYSTOSCOPY. BASED ON THE CYSTOSCOPY, THE SURGEON NOTED THAT IT WAS CLEAR THAT WHAT WE HAD FELT WAS A VAGINAL DEFECT WAS ACTUALLY AN INCIDENTAL CYSTOTOMY. UPON INSPECTION OF THE PATIENT'S BLADDER, A SPILLAGE OF METHYLENE BLUE INTO THE ABDOMINAL CAVITY WAS OBSERVED. A UROLOGY SURGEON WAS CONTACTED AND THE DA VINCI SI SYSTEM WAS RE-DOCKED TO THE PATIENT. THE UROLOGY SURGEON REPAIRED THE CYSTOTOMY UTILIZING THE DA VINCI SI SYSTEM. AFTER COMPLETION OF THE REPAIR, THE UROLOGY SURGEON PERFORMED A CYSTOSCOPY TO INSPECT THE CYSTOTOMY REPAIR. THE SURGEON NOTED THAT THE REPAIR APPEARED TO BE TIGHT WITHOUT ANY EVIDENCE OF PERSISTENT LEAKAGE AND THERE WAS BILATERAL URINE FLOW FROM BOTH URETERAL ORIFICES. SHE ALSO INDICATED THAT THE DA VINCI SYSTEM WAS AGAIN UNDOCKED AND A FOLEY WAS REPLACED IN THE BLADDER. THE OPERATIVE REPORT INDICATED THAT THE PATIENT WAS RETURNED TO THE DORSAL SUPINE POSITION , AND THE GENERAL ANESTHETIC WAS REVERSED WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY, (B)(6) 2011. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT HAD A FOLLOW-UP APPOINTMENT IN A CLINIC ON (B)(6) 2011, FOR THE CYSTOTOMY PROCEDURE. A CYSTOGRAM PERFORMED THAT SAME DAY SHOWED THAT THE BLADDER IS HEALED WITH NO EXTRAVASATION. THE MEDICAL RECORD ALSO INDICATED THAT THE PATIENT WAS ABLE TO URINATE PART OF INFUSED VOLUME INTO HER BLADDER. ON (B)(6) 2012 THE PATIENT UNDERWENT A CYSTOSCOPY PROCEDURE FOR A PREOPERATIVE DIAGNOSIS OF RECURRENT PYELONEPHRITIS POST CYSTOTOMY AND HISTORY OF LEFT FLANK PAIN WITH VOIDING CONTRACTION. ACCORDING TO THE OPERATIVE REPORT, THE BLADDER MUCOSA WAS NORMAL EXCEPT FOR A SECOND URETERAL ORIFICE LOCATED POSTEROLATERALLY WITH ADJACENT SCAR TISSUE. THIS GIVES IT THE APPEARANCE OF A REIMPLANTED URETER. THE PATIENT WAS FOUND TO HAVE A LEFT ECTOPIC URETER. THE PATIENT'S MEDICAL RECORD FROM (B)(6) 2012, INDICATED THAT THE PATIENT HAD SUSTAINED A LEFT URETERAL INJURY DURING A HYSTERECTOMY PROCEDURE THAT WAS MANAGED WITH A DIRECT REIMPLANT AT THE TIME. THE MEDICAL RECORD ALSO INDICATED THAT SINCE THE SURGICAL PROCEDURE, THE PATIENT COMPLAINED OF CHRONIC PAIN ON THE LEFT AND SHE WAS NOTED TO HAVE VESICOURETERAL REFLUX THROUGH THIS URETER. IN ADDITION, THE MEDICAL RECORD INDICATED THAT THE PATIENT UNDERWENT TWO DEFLUX INJECTIONS VIA CYSTOSCOPY THAT WERE UNSUCCESSFUL. ON (B)(6) 2012, THE PATIENT UNDERWENT AN OPEN INTRAVESICAL URETERAL REIMPLANT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED DA VINCI SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY TO HER BLADDER AND URETER DURING A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE PATIENT'S INJURIES OCCURRED. IT IS ALSO UNKNOWN IF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S REPORTED INJURIES.

    Description of Event or Problem · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL COMPLAINT ALLEGED THAT THE USAGE OF THE DA VINCI ROBOT RESULTED IN AN INJURY TO THE BLADDER, WHICH CAUSED THE CLIENT TO ENDURE OVER A YEAR OF PAIN, MEDICATION, DOCTORS' VISITS, AND FINALLY ANOTHER SURGERY TO FURTHER CORRECT THE DAMAGE DONE BY THE DA VINCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353923 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES