BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 4429210 · Received January 16, 2015

    Report

    Report Number
    2955842-2015-00107
    Event Type
    Death
    Date Received
    January 16, 2015
    Date of Event
    October 3, 2007
    Report Date
    December 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K021036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. A MEDICAL REVIEW HAS BEEN PERFORMED BY A PERSON QUALIFIED TO MAKE A MEDICAL JUDGMENT (SURGEON) BASED ON THE AVAILABLE INFORMATION PROVIDED. THE MEDICAL REVIEWER INDICATED THAT THE BOWEL PERFORATION WAS NOT CAUSED BY THE ORIGINAL DA VINCI SURGERY BUT INSTEAD FROM SEVERE COLONIC DISTENSION, PRESUMABLY FROM SEVERE CONSTIPATION. THE CECUM, WHICH IS THE THINNEST WALLED LOCATION OF THE COLON, IS A TYPICAL SITE OF A PERFORATION WHEN THE COLON LUMEN IS TOO LARGE FROM DISTENSION. 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 POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND UMBILICAL HERNIA REPAIR ON (B)(6) 2007. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT UNDERWENT THE DA VINCI SURGICAL PROCEDURE WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS. PER THE MEDICAL RECORDS, THE PATIENT WAS STARTED ON LEVAQUIN ON POST-OP DAY 2 FOR POSSIBLE CELLULITIS. SHE HAD SLOW RETURN OF BOWEL FUNCTION. THE PATIENT WAS ONLY PASSING SMALL AMOUNTS OF GAS THROUGHOUT THE FIRST FEW DAYS OF HER HOSPITAL COURSE AND FELT VERY UNCOMFORTABLE GOING HOME. HER BOWEL REGIMEN WAS INITIATED ORALLY AND RECTALLY ON POST-OP DAY 4 AND BEGAN TO PASS GAS ON POST-OP DAY 5. SHE HAD A SMALL BOWEL MOVEMENT AND BY POST-OP DAY 6 FELT VERY COMFORTABLE GOING HOME. THE PATIENT WAS DISCHARGED ON (B)(6) 2007. ON (B)(6) 2008, THE PATIENT WAS SEEN IN AN ER FOR ABDOMINAL PAIN. THE PATIENT DID NOT HAVE ANY BOWEL MOVEMENTS FOR 3 DAYS. SHE WAS GIVEN MAGNESIUM CITRATE, AND OFFERED DULCOLAX SUPPOSITORIES TO START THE FOLLOWING DAY. AN X-RAY REVEALED A NON-OBSTRUCTED GAS PATTERN AND NO FREE AIR. A COLONOSCOPY WAS RECOMMENDED. HER SISTER, WHO WAS AN IDENTICAL TWIN, HAD SEVERAL COLONOSCOPIES FOR POLYPS. AN ASSESSMENT INCLUDED ABDOMINAL PAIN AND PROBABLE SYMPTOMATIC CONSTIPATION. ON (B)(6) 2008, THE PATIENT WAS SEEN IN THE ER FOR ABDOMINAL PAIN. HER LAST BOWEL MOVEMENT HAD BEEN THE PREVIOUS SUNDAY ON (B)(6) 2008. THE PATIENT HAD A HISTORY OF CHRONIC CONSTIPATION AND NOTED SHE HAS ALWAYS REQUIRED TO COME TO THE ER TO GET HER BOWEL MOVEMENTS GOING. AN ACUTE ABDOMEN SERIES WAS DONE AND WAS OBVIOUS FOR CONSTIPATION WITH NO SPECIFIC FINDINGS OF OBSTRUCTION OR FREE AIR. SHE WAS GIVEN A FLEET ENEMA AND THEN HAD A SIGNIFICANT BOWEL MOVEMENT. ANOTHER FLEET ENEMA WAS OFFERED BUT THE PATIENT REFUSED. SHE WAS DISCHARGED HOME WITH MAGNESIUM CITRATE. THE PATIENT RETURNED TO THE ER ON (B)(6) 2008 WITH SEVERE ABDOMINAL PAIN AND WAS ADMITTED. THE PATIENT COMPLAINED OF HAVING INTERMITTENT ABDOMINAL PAIN AND CONSTIPATION FOR ABOUT 2 MONTHS WHICH HAD BEEN WORSE OVER THE PAST ONE AND HALF WEEKS. CONSULTATION NOTED A HISTORY OF TOTAL ABDOMINAL HYSTERECTOMY FACILITATED WITH DA VINCI OPERATIVE ROBOT; YET SHE HAD A MIDLINE ABDOMINAL SCAR. THE PATIENT WAS FOUND TO BE IN EXTREMIS ON THE FLOOR IN THE EVENING WITH A RIGID ABDOMEN, FREE AIR, HYPOTENSION, HYPOXIA, AND EVIDENCE OF ASPIRATION DURING HER INTUBATION. SHE WAS TAKEN TO THE OR EMERGENTLY. ON (B)(6) 2008, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY; ILEOCOLECTOMY FOLLOWED BY TRANSVERSE COLECTOMY; EXPLORATION OF ENTIRE ABDOMEN WITH EVACUATION OF GROSS STOOL CONTAMINATION AND MULTIPLE UNDIGESTED MEDICATIONS. UPON OPENING HER UP, SHE WAS FOUND TO HAVE GROSS FECAL CONTAMINATION IN ALL FOUR QUADRANTS OF ABDOMEN, AND LARGE QUANTITIES OF UNDIGESTED PILLS. SHE WAS FOUND TO HAVE A CECAL PERFORATION AND ISCHEMIC BOWEL. SURGEONS BEGAN THE PROCESS OF RESECTING THE DEAD BOWEL, BUT IT BECAME APPARENT THAT THE PATIENT WOULD NOT TOLERATE TEDIOUS MOBILIZING. THE DECISION WAS MADE TO RESECT THE TRANSVERSE COLON AND BEGIN PREPARATIONS TO PACK THE PATIENT AND CLOSE HER AND ARRANGE TRANSFER TO HIGHER LEVEL OF CARE. INITIALLY, AN ATTEMPT WAS MADE TO ARRANGE AIR TRANSPORT BUT THE HELICOPTERS WERE GROUNDED SECONDARY TO WEATHER AND SHE WOULD HAVE TO GO IN MOBILE ICU. THE SITE FELT THERE WAS A STRONG CHANCE SHE WOULD NOT MAKE IT TO TRANSFER. [NO MEDICAL RECORDS REGARDING THE TRANSFER WERE RECEIVED.] PER THE AUTOPSY REPORT, THE PATIENT DIED AT APPROXIMATELY 3:30 AM ON (B)(6) 2008. THE CAUSE OF DEATH WAS AN INFARCTED BOWEL. ANATOMIC FINDINGS INCLUDED INFARCTED BOWEL (SMALL AND LARGE) WITH ASSOCIATED ACUTE PERITONITIS. THE AUTOPSY REPORT INDICATED THAT THE CLIENT WAS STATUS POST COLECTOMY FOR PERFORATED INFARCTED COLON, RECENT, AND REFERRED TO AN ATTACHED SURGICAL SPECIMEN REPORT WHICH DESCRIBED THE BOWEL PERFORATION(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39150 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H| L| R