BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3444767 · Received November 3, 2013

    Report

    Report Number
    2955842-2013-04981
    Event Type
    Injury
    Date Received
    November 3, 2013
    Date of Event
    August 24, 2009
    Report Date
    October 4, 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 OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009 FOR ADENOCARCINOMA OF PROSTATE WITH CLINICAL STAGE T1C AND GLEASON 6. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND FOLLOW UP MEDICAL RECORDS. IN PREPARATION FOR PLANNED DA VINCI PROSTATECTOMY, A DIAGNOSTIC LAPAROSCOPY WITH POSSIBLE LYSIS OF ADHESIONS WAS PERFORMED ON (B)(6) 2009 BECAUSE THERE WERE POSSIBLE ADHESIONS IN THE UPPER ABDOMEN NOTED ABOVE WHERE ALL THE DA VINCI PORTS NEEDED TO BE PLACED. FINDINGS NOTED NO EVIDENCE OF ADHESIONS IN THE AREA NEEDED TO PLACE THE LAPAROSCOPIC PORTS WITH SUPERIORLY LOCATED ADHESIONS NOT MOBILIZED. ACCORDING TO THE DA VINCI OPERATIVE REPORT, THE CORRECT PLANE FOR BLADDER NECK TRANSECTION OF THE POSTERIOR PORTION WAS NOT ENTERED. THE BLADDER NECK WAS TRANSECTED FURTHER BACK BUT BECAUSE OF THE PREVIOUS INCISION THROUGH ALMOST A FULL THICKNESS OF THE PROSTATE DISSECTING ANY MORE POSTERIORLY WAS NOT POSSIBLE. RECTAL ATTACHMENTS WERE DIVIDED, WHICH WAS EXTREMELY DIFFICULT BECAUSE THE RECTUM WAS ADHERENT AND TENTED UP BY THE ATTACHED PROSTATE WITH A SMALL HALF TO 1 CENTIMETER RECTAL OPENING CREATED AND IMMEDIATELY IDENTIFIED. THE CLEAN INCISION IN THE ANTERIOR SURFACE OF THE RECTUM WAS INSPECTED WITH NO CONTAMINATION NOTED AND THE DECISION TO REPAIR IT PRIMARILY. THERE WAS REPORT OF AN INTRAOPERATIVE COMPLICATION OF AN UNINTENTIONAL DIRECT ENTRY RECTAL MUCOSAL INJURY WHICH WAS REPAIRED PRIMARILY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. WITHIN A FEW DAYS ON (B)(6) 2009, A CT OF THE PELVIS WAS INDICATED DUE TO FECES IN FOLEY CATHETER. THE IMPRESSION WAS FISTULOUS COMMUNICATION EXTENDING FROM BLADDER TO THE RECTUM VIA THE PROSTATIC URETHRA AT THE MIDLINE. ON (B)(6) 2009, CT OF THE PELVIS REVEALED COMPLEX MULTILOCULATED GAS AND FLUID CONTAINING PENILE ABSCESS. HE POSTOPERATIVELY DEVELOPED A RECTOVESICAL FISTULA WHICH WAS TREATED CONSERVATIVELY. HE PRESENTED TO THE OFFICE ON (B)(6) 2009 WITH DISCOMFORT IN HIS PERINEUM. A CT SCAN SHOWED AN ABSCESS WITH SURGERY PLANNED AND THE ASSESSMENT OF COLOVESICAL FISTULA COMPLICATED BY PERIURETHRAL ABSCESS. ON (B)(6) 2009, THE PATIENT WAS ADMITTED AFTER HE DEVELOPED A PERIURETHRAL ABSCESS AFTER DIFFICULT PROSTATECTOMY COMPLICATED BY A RECTAL INJURY. A DIVERTING COLOSTOMY WAS PERFORMED AS IT WAS IMPERATIVE TO DIVERT HIS FECAL STREAM. ON (B)(6) 2009, A WOUND CULTURE WAS (B)(6) . HE WAS TAKEN TO SURGERY TWICE FOR IRRIGATION AND REPACKING OF THE ABSCESS. HEALING WAS SATISFACTORY AND HE LEARNED HOW TO HANDLE HIS COLOSTOMY. ON (B)(6) 2009, A CREATION OF END LOOP SIGMOID COLOSTOMY FOR RECTOVESICAL FISTULA WAS PERFORMED. AFTER THE COLOSTOMY, THE SCROTAL/PERIURETHRAL ABSCESS WAS IRRIGATED AND REPACKED. ON (B)(6) 2009, A WOUND CULTURE WAS (B)(6). HE WAS DISCHARGED ON (B)(6) 2009 WITH PLANS FOR FORMAL REPAIR OF RECTOVESICAL FISTULA IN THE NEAR FUTURE. ON (B)(6) 2010, THE PATIENT UNDERWENT A CYSTOURETHROSCOPY, DILATION OF BLADDER NECK CONTRACTURE, SUPRAPUBIC CYSTOTOMY, LEFT URETERAL ORIFICE CATHETERIZATION, TRANSPERINEAL REPAIR OF RECTOURETHRAL FISTULA, ROTATION OF LEFT GRACILIS MUSCLE FLAP INTO ANTERIOR PERINEAL SPACE AS INTERIM POSITION FLAP FOR DIAGNOSIS OF RECTOURETHRAL FISTULA AND BLADDER NECK CONTRACTURE. FINDINGS NOTED FAIRLY LARGE DEFECT PROXIMAL TO THE BLADDER NECK ANASTOMOSIS EXTENDING INTO THE RECTUM. EXTENSIVE DIFFICULT DISSECTION DUE TO DENSE ADHESIONS WAS NOTED WITH RECTUM FINALLY MOBILIZED OFF OF THE BLADDER. RECTAL RENT WAS SUTURE REPAIRED AND URINARY DEFECT WHICH WAS QUITE RIGID BUT SMALL WAS CLOSED IN THE ANASTOMOTIC AREA. A MEDICAL RECORD DATED (B)(6) 2010 NOTED THE PATIENT WAS DOING VERY WELL WITH CLOSURE OF HIS COLOSTOMY PLANNED. ON (B)(6) 2010, THE PATIENT PRESENTED FOR PREOPERATIVE DISCUSSION OF TAKE DOWN OF HIS COLOSTOMY WHICH WAS CREATED WHEN HE HAD A RECTAL VESICLE FISTULA AFTER DA VINCI PROSTATECTOMY. ON (B)(6) 2010, THE PATIENT UNDERWENT A CYSTOSCOPY WITH CYSTOGRAM AND URETHROGRAM WITH MILD DEGREE OF NARROWING AT URETHRA IN BULBOMEMBRANOUS AREA AND BLADDER NECK. NO FISTULOUS OPENING WAS NOTED AND HEALING APPEARED TO BE COMPLETE. NO COMPLICATIONS WERE REPORTED. LAST MEDICAL RECORDS WERE DATED (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565531 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES