BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3444210 · Received November 1, 2013

    Report

    Report Number
    2955842-2013-04944
    Event Type
    Injury
    Date Received
    November 1, 2013
    Date of Event
    June 29, 2011
    Report Date
    October 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE AND POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED OPERATIVE COMPLICATIONS FROM UNDERGOING A DA VINCI S SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S RADICAL PARAMETRECTOMY, UPPER VAGINECTOMY, BILATERAL PELVIC LYMPH NODE DISSECTION, BILATERAL COMPLETE URETEROLYSIS, AND LEFT URETERAL STENT PLACEMENT FOR UNEXPECTED DIAGNOSIS OF AN ENDOCERVICAL ADENOCARCINOMA AFTER HYSTERECTOMY AND RETROPERITONEAL FIBROSIS ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH OPERATIVE REPORTS (2X (B)(6) 2011). ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H&P) (B)(6) 2011, DISCHARGE SUMMARY (B)(6) 2011, OUTSIDE SLIDE REPORT - (B)(6) 2011, ONCOLOGY CONSULTATION (B)(6) 2011 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS REPORT OF AN INTRAOPERATIVE CYSTOTOMY DURING URETEROLYSIS OF THE LEFT URETER. THE OPERATION WAS INITIATED WITH BILATERAL PLACEMENT OF URETERAL CATHETERS, THEN AN EEA SIZER WAS PLACED IN THE VAGINA AND A PNEUMOPERITONEUM CREATED THROUGH A SUPRAUMBILICAL INCISION. ON INSPECTION THERE WAS EVIDENCE OF SIGNIFICANT RETROPERITONEAL FIBROSIS ON THE LEFT OF THE PELVIS. DENSE ADHESIONS OF HER RECTOSIGMOID COLON TO THE LEFT PELVIC SIDEWALL WERE OBSERVED. HER LEFT URETER WAS DENSELY ADHERED TO THE PERITONEUM ON THE LEFT. THE PATIENT HAD DENSE ADHESIONS OF HER BLADDER TO THE UPPER VAGINA. SUBSEQUENTLY, THE PARAVESICAL AND PARARECTAL SPACES WERE COMPLETELY ELABORATED AND DISSECTED, INCLUDING A COMPLETE BILATERAL URETEROLYSIS, CLIPPING OF THE UTERINE ARTERIES, DISSECTION OF THE VAGINAL WALL FROM THE BLADDER AND MOBILIZATION OF THE COLON. DURING THE LEFT URETEROLYSIS A HALF-CENTIMETER CYSTOTOMY WAS MADE INTO THE BLADDER ON THE LEFT. THIS WAS CONFIRMED SECONDARY TO PNEUMOPERITONEUM IN THE FOLEY CATHETER BAG AND BEING ABLE TO SEE THE FOLEY BULB WITHIN THE DEFECT. THE CYSTOTOMY WAS CLOSED LATER ON IN TWO LAYERS WITH 3-0 AND 2-0 VICRYL. SUBSEQUENTLY, THE SPECIMEN WAS DISSECTED OFF THE BLADDER AND THE RECTUM, AND A 2CM AREA OF THE VAGINA WAS REMOVED TRANSVAGINALLY TOGETHER WITH THE REST OF THE SPECIMEN. THE VAGINA WAS CLOSED WITH A 0 VICRYL IN A RUNNING FASHION IN TWO LAYERS. BILATERAL PELVIC LYMPHADENECTOMY WAS COMPLETED. NO VESICAL LEAK WAS OBSERVED AFTER FILLING THE BLADDER WITH METHYLENE BLUE. FIBRILLAR WAS PLACED ALONG THE LYMPHATIC BEDS IN THE DISSECTION AREA AND THE PROCEDURE WAS TERMINATED. THE RIGHT URETERAL CATHETER WAS REMOVED. THE LEFT URETERAL CATHETER HAD A STIFF GUIDEWIRE PLACED WITHIN THE URETER AND THE CATHETER WAS EXCHANGED FOR A DOUBLE J URETERAL STENT. THE URETERAL CATHETER WAS REMOVED FROM THE LEFT URETER. POSTOPERATIVELY, THE PATIENT EXPERIENCED AN INTERMITTENT SINUS TACHYCARDIA AND FEVER THAT WAS TREATED EMPIRICALLY WITH ANTIBIOTICS. ON (B)(6) 2011, SHE WAS DISCHARGED HOME WITH A FOLEY CATHETER IN PLACE AND HOME VNA. ON (B)(6) 2011 THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH EXTREME GENERALIZED ABDOMINAL PAIN, NAUSEA AND VOMITING. THE PATIENT WAS EVALUATED IN THE HOSPITAL AND FOUND TO HAVE STABLE VITAL SIGNS, NORMAL LABORATORY VALUES, BUT A CT SCAN THAT SHOWED A QUESTION OF A LEFT URETERAL STENT MIGRATION. ON (B)(6) 2011, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH LEFT URETERONEOCYSTOTOMY AND REPLACEMENT OF LEFT URETERAL STENT FOR URINOMA AND QUESTION OF LEFT URETERAL STENT MIGRATION. EXAMINATION AT THAT TIME REVEALED THAT HER VAGINA WAS HEALING WELL AND THAT HER RIGHT URETER WAS INTACT. POSTOPERATIVELY THE PATIENT BEGAN HAVING COPIOUS VAGINAL LEAKAGE. A CT-UROGRAM WAS DONE WHICH REVEALED A QUESTION OF CONTRAST NEAR THE LEFT ASPECT OF THE BLADDER/URETERAL ANASTOMOSIS. ON (B)(6) 2011, SHE WENT AGAIN TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY WITH REPAIR OF THE RIGHT URETER AND RIGHT URETERAL STENT PLACEMENT WAS PERFORMED TOGETHER WITH A DIAGNOSTIC CYSTOSCOPY. EXAMINATION OF THE VAGINA DURING THE OPERATION REVEALED NO EVIDENCE OF OBVIOUS DEFECT, BUT WITH THE PATIENT HAVING RECENT DRAINAGE OF URINE AND PERITONEAL FLUID THROUGH THE VAGINA AND OBVIOUS OPENING OF THE LEFT ASPECT OF THE VAGINA, THE VAGINAL CUFF WAS REINFORCED WITH 2-0 VICRYL SUTURES IN AN INTERRUPTED FASHION. POSTOPERATIVELY, BESIDES A BLOOD TRANSFUSION THAT WAS REQUIRED AFTER THE FIRST SURGERY, SHE HAD AN UNEVENTFUL POSTOPERATIVE COURSE AND WAS DISCHARGED HOME ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562168 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE