BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3183214 · Received June 21, 2013

    Report

    Report Number
    2955842-2013-02267
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    September 25, 2012
    Report Date
    May 23, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE HOSPITAL WHERE THE PATIENT'S DA VINCI S HYSTERECTOMY WITH BSO (BILATERAL SALPINGO-OOPHORECTOMY) PROCEDURE WAS PERFORMED. THE HOSPITAL'S RISK MANAGER INDICATED THAT THERE WAS NO RECORD OF THE PATIENT BEING RE-ADMITTED INTO THE HOSPITAL AFTER BEING DISCHARGED. THERE WAS NO REPORT BY THE SURGICAL STAFF THAT AN INJURY TO THE PATIENT OCCURRED DURING THE SURGICAL PROCEDURE AND NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED TO HAVE BEEN EXPERIENCED BY THE PATIENT. THE RISK MANAGER INDICATED THAT THERE WAS NO REPORT BY THE SURGICAL STAFF THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. DUE TO HIPAA REGULATIONS, THE RISK MANAGER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO POST SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT AS A RESULT OF INFECTION. BASED ON THE INFORMATION PROVIDED ISI IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE PERITONITIS AND INTRAABDOMINAL ABSCESS THAT THE PATIENT DEVELOPED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL DEMAND INDICATING THAT A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE PERFORMED ON (B)(6) 2012, EXPERIENCED POST-SURGICAL COMPLICATIONS, REQUIRING THE PATIENT TO UNDERGO SUBSEQUENT TREATMENT. THE PATIENT'S OPERATIVE REPORTS AND OTHER RELATED MEDICAL RECORDS WERE ALSO PROVIDED TO ISI. THE PATIENT'S MEDICAL RECORDS INDICATED THE FOLLOWING: THE PATIENT'S MEDICAL HISTORY AS INDICATED IN THE OPERATIVE REPORT REGARDING THE DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE INDICATED THAT THE PATIENT EXPERIENCED CONTINUED AND WORSENING PAIN WITH HER MENSTRUAL CYCLE. THE OPERATIVE REPORT DID NOT INDICATE THAT ANY INTRA-OPERATIVE COMPLICATIONS WERE EXPERIENCED BY THE PATIENT. THE PATIENT'S UTERUS WAS REMOVED VAGINALLY AND EXCELLENT HEMOSTASIS WAS NOTED. THE PATIENT'S ABDOMINAL CAVITY WAS IRRIGATED, INSPECTED AND THERE WAS NO BLEEDING FROM ANY SITES. THERE WAS NO INDICATION IN THE PATIENT'S OPERATIVE REPORT THAT ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2013 THE PATIENT UNDERWENT A LAPAROTOMY PROCEDURE AT A DIFFERENT HOSPITAL. THE PATIENT'S OPERATIVE SUMMARY INDICATED THAT THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS PERITONITIS WITH INTRA-ABDOMINAL ABSCESS. THE PATIENT SUBSEQUENTLY DEVELOPED WORSENING ABDOMINAL PAIN AND SIGNS OF MULTIORGAN DYSFUNCTION INCLUDING RENAL FAILURE AFTER UNDERGOING A ROBOTIC HYSTERECTOMY. THE PATIENT WAS TACHYCARDIC INTO THE 130'S - 140'S UPON ARRIVAL TO THE HOSPITAL AND APPEARED TO BE VERY ILL. THE PATIENT EXPERIENCED INTERMITTENT EPISODES OF HYPOTENSION THAT WERE ALL CONSISTENT WITH SEPTIC SHOCK AND THAT THE PATIENT'S ABDOMINAL EXAMINATION WAS VERY CONCERNING FOR PERITONITIS. THE PATIENT WAS RESUSCITATED AND GIVEN BROAD SPECTRUM ANTIBIOTICS AND WAS TAKEN TO THE OPERATING ROOM WITH A PRESUMED DIAGNOSIS OF BOWEL PERFORATION BELIEVED TO HAVE BEEN DUE TO AN INTRAOPERATIVE INJURY THAT POSSIBLY OCCURRED DURING THE PATIENT'S INITIAL SURGERY. DURING THE LAPAROTOMY PROCEDURE, THE SURGEON ENCOUNTERED A POCKET OF FRANK PUS NEAR ONE OF THE PATIENT'S PREVIOUS PORT SITE INCISIONS. UPON OPENING THE PATIENT'S FASCIA, FURTHER PURULENCE WITHIN THE PATIENT'S ABDOMINAL CAVITY WAS NOTED. THE PATIENT WAS MORBIDLY OBESE, A THICK ABDOMINAL WALL AND DEEP PELVIS, WHICH MADE VISUALIZATION OF THE SURGICAL AREA VERY DIFFICULT. PURULENT MATERIAL AND FIBRINOUS EXUDATE WAS ALSO FOUND TO BE SCATTERED THROUGHOUT THE PATIENT'S ABDOMEN ON VARIOUS SECTIONS OF THE SMALL BOWEL AS WELL AS THE ENTIRE COLON AND UP OVER THE LIVER. IT WAS NOTED THAT THE FLUID DID NOT APPEAR TO BE FRANK STOOL OR SUCCUS. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S SIGMOID COLON HAD A VERY SMALL SEROSAL TEAR ON THE ANTERIOR SURFACE OF THE PROXIMAL RECTUM. THE TEAR DID NOT APPEAR TO BE A FULL-THICKNESS INJURY AND THE SURGEON REPAIRED THE AFFECTED AREA USING 3-0 INTERRUPTED SILK SUTURES. EXAMINATION OF THE PATIENT'S COLON, SPLENIC FLEXTURE AND TRANSVERSE COLON FOUND NO EVIDENCE OF DAMAGE. EXAMINATION OF THE ANTERIOR SURFACE OF THE PATIENT'S STOMACH AND GASTROINTESTINAL (GI) TRACT FOUND NO EVIDENCE OF PERFORATION AND A PROCTOSCOPY PERFORMED FOUND NO EVIDENCE OF BLOOD WITHIN THE PATIENT'S RECTUM AND THERE WERE NO ABNORMALITIES WITHIN THE RECTAL MUCOSA VISUALIZED. THE PATIENT'S COLON WAS INSUFFLATED AND PINCHED OFF IN THE DESCENDING COLON AND THE INSUFFLATED PORTION WAS SUBMERGED UNDER WATER; HOWEVER, NO EVIDENCE OF LEAKAGE WAS FOUND. THE PATIENT'S OPERATIVE SUMMARY INDICATED THAT THE SURGEON WAS FAIRLY SATISFIED THAT THERE WAS NO CONTINUED PERFORATION WITHIN THE PATIENT'S INTRA-ABDOMINAL GI TRACT. THE SURGEON BELIEVES THAT THE PURULENT-APPEARING FLUID WAS SUGGESTIVE THAT THERE WAS NOT AN ONGOING LEAK FROM THE PATIENT'S GI TRACT. THE PATIENT'S ABDOMEN WAS IRRIGATED WITH WARM BACITRACIN SALINE AND THEN CLOSED USING 1 LOOPED PDS WITH SEVERAL 2 VICRYL INTERNAL RETENTION SUTURES PLACED WITHIN THE FASCIA. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS EXPERIENCED BY THE PATIENT. THE PATIENT'S OPERATIVE SUMMARY INDICATED THAT AN INSPECTION OF THE PATIENT'S VAGINAL CUFF FOUND THAT IT APPEARED TO BE INTACT. A CYSTOURETHROSCOPY PERFORMED FOUND THAT THE PATIENT'S BLADDER WAS INTACT AND EFFLUX OF INDIGO CARMINE FROM BOTH URETERAL ORIFICES WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282681 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other DA VINCI S SURG SYS., INSTRUMENTS AND ACCESSORIES