BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3444109 · Received November 1, 2013

    Report

    Report Number
    2955842-2013-04908
    Event Type
    Injury
    Date Received
    November 1, 2013
    Date of Event
    January 29, 2008
    Report Date
    October 2, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K021036
    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 POST-OPERATIVE COMPLICATION(S) 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 SUSTAINED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI 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 HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC AND PERIAORTIC LYMPH NODE DISSECTION FOR ENDOMETRIAL CARCINOMA ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PATIENT HAD A 6-8 WEEK SIZE UTERUS WITH GROSSLY NORMAL ADNEXA BILATERALLY. EXCELLENT HEMOSTASIS WAS ACHIEVED AND CARE WAS TAKEN TO RETRACT BOTH URETERS LATERALLY. DESPITE THE MENTION OF EXCELLENT HEMOSTASIS, 200 ML OF BLOOD LOSS OCCURRED DURING THE PROCEDURE. DURING THE PELVIC LYMPH NODE DISSECTION GREAT CARE WAS TAKEN TO IDENTIFY THE OBTURATOR NERVE AND THE URETERS SO AS NOT TO INJURE THESE STRUCTURES. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION AND SUBSEQUENTLY DISCHARGED ON (B)(6) 2008 FOR A TOTAL STAY OF THREE DAYS. AN OPERATIVE NOTE DATED (B)(6) 2008 NOTED A COMPLICATED POSTOPERATIVE COURSE INCLUDING ILEUS, PELVIC AND ABDOMINAL FLUID COLLECTIONS, FEVER, LEUKOCYTOSIS AND JAUNDICE AFTER HER (B)(6) PROCEDURE. SHE WAS READMITTED TO THE HOSPITAL ON (B)(6) 2008 FOR POSTOPERATIVE PELVIC AND ABDOMINAL ABSCESS THAT REQUIRED A LAPAROTOMY. SOMETIME AFTER (B)(6), THREE INTERVENTIONAL RADIOLOGY DRAINS WERE PLACED AND CULTURES ON (B)(6) 2008 GREW E. COLI. THE PATIENT REPORTED INCONTINENCE. A CYSTOSCOPY AND BILATERAL RETROGRADE PYELOGRAM WAS PERFORMED IN WHICH BOTH URETERS APPEARED TO BE INTACT. NECROTIC TISSUE WAS NOTED AT THE VAGINAL CUFF. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM. ON (B)(6) 2008 AN EXPLORATORY LAPAROTOMY WAS PERFORMED IN WHICH ADHESIONS OF THE SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL AND OMENTUM WERE LYSED. EDEMA OF THE SMALL BOWEL AND OMENTUM WERE NOTED AND THE DISSECTION OF THE OMENTUM FROM THE WALL TOOK 30-45 MINUTES. A POCKET OF PURULENT FLUID WAS DISCOVERED IN THE RIGHT MID-ABDOMEN, WHICH WAS SENT OFF FOR CULTURE. SIMILAR FOR THE LEFT MID ABDOMEN, COPIOUS PURULENT MATERIAL WAS OBSERVED. THE PREVIOUSLY PLACED INTERVENTIONAL RADIOLOGY DRAINS WERE FOUND TO BE INEFFECTIVE FURTHER DOWN INTO THE PELVIS. MULTIPLE BOWEL ADHESIONS WERE LEFT AS-IS. DENSE ADHESIONS OF THE RECTOSIGMOID TO THE BLADDER WERE ENCOUNTERED. SHE WAS DISCHARGED ON (B)(6) 2008. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2008 WITH RIGHT LOWER QUADRANT PAIN. A CT SCAN SHOWED RIGHT LOWER QUADRANT COLLECTION FROM A PROBABLY ABSCESS. INTERVENTIONAL RADIOLOGY DRAINED 40 ML OF CLEAR SEROUS FLUID ON (B)(6) 2008, WHICH IMPROVED THE PATIENT'S PAIN STATUS. SHE WAS DISCHARGED HOME IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563336 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE