{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2955842-2013-03704", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130919", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120514", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130920", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "473386", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130919", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20130919", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "68 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiopulmonary Arrest", "Death", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Tachycardia", "Perforation of Vessels", "Electrolyte Imbalance", "Injury", "Multiple Organ Dysfunction Syndrome" ] } ], "distributor_city": "", "date_report": "20130820", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3358952", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130820", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "20410260", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE 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. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. AT THIS TIME, DETAILS REGARDING HOW THE TROCAR PLACEMENT WAS PERFORMED BY THE SURGEON IS UNKNOWN. IT IS ALSO UNKNOWN WHO THE MANUFACTURER IS OF THE 12 MM TROCAR INVOLVED WITH THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT'S MESENTERIC VEIN WAS INJURED PRIOR TO THE START OF A PLANNED DA VINCI SI SURGICAL PROCEDURE AND THE PATIENT SUBSEQUENTLY EXPIRED DUE TO MULTI-SYSTEM ORGAN FAILURE." }, { "mdr_text_key": "19998705", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO SUSTAINED AN INJURY TO HER MESENTERIC VEIN PRIOR TO THE START OF A PLANNED DA VINCI SI BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY PROCEDURE ON (B)(6), 2012. ACCORDING TO THE PROCEDURE NOTE, THE INJURY OCCURRED DURING TROCAR PLACEMENT FOR AN EXPLORATORY LAPAROTOMY FOR STAGING OF UTERINE CANCER. THE PATIENT HAD NOT YET BEEN DOCKED TO THE DA VINCI SI SURGICAL SYSTEM AT THE TIME THE INJURY OCCURRED. THE PATIENT'S MEDICAL HISTORY INCLUDED RECENT TOTAL VAGINAL HYSTERECTOMY ((B)(6) 2012) THAT REVEALED STAGE IB ENDOMETRIAL CARCINOMA THAT REQUIRED SURGICAL STAGING. PRIOR TO THE START OF THE PLANNED SURGICAL PROCEDURE, THE PATIENT WAS INFORMED OF THE RISKS, BENEFITS, PERIOPERATIVE COMPLICATIONS, AND CONVALESCENCE RELATED TO THE PROCEDURE AND SURGICAL CONSENT WAS SIGNED. ACCORDING TO THE OPERATIVE REPORT, AT THE BEGINNING OF THE PLANNED SURGICAL PROCEDURE, A 12 MM TROCAR WAS PLACED SUPRAUMBILICALLY. THE PATIENT WAS NOTED TO HAVE MASSIVE OMENTAL ADHESIONS TO THE PELVIS, SMALL BOWEL, DESCENDING COLON, AND ANTERIOR ABDOMINAL WALL. UPON DIRECT INSERTION OF THE TROCAR, VENOUS APPEARING BLOOD BEGAN TO FILL THE TROCAR. THE SURGEON IMMEDIATELY CONVERTED TO AN OPEN PROCEDURE WITH THE TROCAR KEPT IN PLACE. THE SURGEON STATED THAT THE TROCAR HAD GONE THROUGH THE OMENTUM AND HAD DAMAGED VESSELS COMING OFF THE SUPERIOR MESENTERIC VEIN. AFTER THE BLEEDING WAS CONTROLLED THROUGH SUTURE LIGATION, SURGICAL CLIPS, FIBRILLAR, AND DIRECT PRESSURE, THE SURGEON THEN CONTINUED WITH BILATERAL PELVIC LYMPH NODE DISSECTION. DURING THE PROCEDURE, ADDITIONAL BLEEDING FROM THE MESENTERIC AREA WAS OBSERVED AND ADDITIONAL SUTURES AND FIBRILLAR WERE USED TO CONTROL THE BLEEDING. NO PARA-AORTIC LYMPH NODE DISSECTION WAS PERFORMED DUE TO THE BLEEDING THAT HAD OCCURRED. THE PATIENT COULD NOT BE EXTUBATED AS HER BLOOD PRESSURE KEPT DROPPING AND A VASCULAR SURGEON WAS CONTACTED AND RE-EXPLORATION OF THE PATIENT'S ABDOMEN WAS PERFORMED. THE PATIENT WAS FOUND TO HAVE ADDITIONAL BLEEDING FROM THE MESENTERIC SITE. THE VASCULAR SURGEON WAS ABLE TO CONTROL THE BLEEDING WITH PRESSURE, SUTURE LIGATION, AND A HEMOSTATIC AGENT. A JP DRAIN WAS PLACED AT THE PATIENT'S RIGHT LOWER QUADRANT AND ALONG THE MESENTERIC BLEEDING. THE PATIENT'S FASCIA AND SKIN WERE THEN CLOSED AGAIN. THE PATIENT REMAINED INTUBATED AND WAS TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) IN A GUARDED CONDITION. WHILE IN THE SICU, THE PATIENT DEVELOPED HYPOTENSION AGAIN AND INCREASED DRAINAGE WAS OBSERVED FROM THE JP DRAIN. THE PATIENT WAS BROUGHT BACK TO THE OR AND RE-EXPLORATION WAS PERFORMED AGAIN. DURING THIS PROCEDURE, LYSIS OF ADHESIONS WAS PERFORMED AND EXAMINATION OF HER ABDOMEN AND INTESTINE WERE PERFORMED. THE SURGEON STATED THAT THE PATIENT'S BOWEL WAS BECOMING ISCHEMIC. THE PATIENT'S ABDOMEN WAS KEPT OPEN AND A BOGATA BAG WAS PLACED ON THE ABDOMEN TO BE ABLE TO EVALUATE THE PATIENT'S STATUS. THE PATIENT WAS THEN BROUGHT BACK TO THE ICU AND RESUSCITATED WITH ADDITIONAL BLOOD PRODUCTS AND FLUIDS. THE FOLLOWING DAY ON (B)(6) 2012, THE SURGEONS EVALUATED THE PATIENT AND DETERMINED THAT THE PATIENT WAS PROGRESSING INTO MULTISYSTEM ORGAN FAILURE. DUE TO SIGNIFICANT BLEEDING FROM THE MESENTERY, THE PATIENT HAD DEVELOPED HYPOTENSION RELATED TO HYPOVOLEMIC SHOCK AND HEMORRHAGIC SHOCK, TACHYCARDIA, HYPOCALCEMIA, AND SEVERE METABOLIC ACIDOSIS. THE PATIENT SUBSEQUENTLY EXPIRED LATER THAT SAME DAY DUE TO CARDIOPULMONARY ARREST AFTER THE DECISION WAS MADE BY THE PATIENT'S FAMILY AND THE SURGEON TO DISCONTINUE ALL SUPPORT. ACCORDING TO THE PATIENT'S DEATH CERTIFICATE, THE PATIENT'S DEMISE OCCURRED ON (B)(6) 2012, AND WAS DUE TO MULTI-SYSTEM ORGAN FAILURE LEADING TO CARDIOPULMONARY ARREST." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }