{ "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": "Injury", "report_number": "2955842-2013-03169", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101222", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "414728", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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": "DA", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SURG INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "53 YR", "patient_sex": "", "patient_weight": "69", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Dehydration", "Extravasation", "Low Blood Pressure/ Hypotension", "Nausea", "Perforation", "Shock", "Rupture", "Injury", "Blood Loss", "Pseudoaneurysm" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305757", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "18621928", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON JULY 25TH, 2013 INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY WITH PELVIC AND PARAAORTIC LYMPH NODE DISSECTION ON (B)(6) 2010. THE PATIENT HAD A DIAGNOSIS OF GRADE II ENDOMETRIAL CANCER AND FIBROID UTERUS. THE SURGICAL PROCEDURE WAS COMPLETED AS PLANNED WITH THE REMOVAL OF UTERUS, TUBES AND OVARIES THROUGH VAGINA WITH PERIAORTIC LYMPHNODE DISSECTION. THE VAGINAL CUFF WAS CLOSED USING INTERRUPTED STITCHES WITHOUT ANY DIFFICULTY. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS EXTUBATED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010 IN GOOD CONDITION WITH A NORMAL HEMATOCRIT LEVEL WITHOUT COMPLICATIONS AS PER THE MEDICAL RECORDS. AFTER ARRIVING HOME THE PATIENT BEGAN TO DEVELOP NAUSEA AND ABDOMINAL PAIN. THIS PERSISTED TO DEHYDRATION AND SHE PRESENTED TO HOSPITAL'S ER REMARKABLY DEHYDRATED ON (B)(6) 2010. A CT-SCAN PERFORMED SHOWED FINDINGS CONSISTENT WITH A POSSIBLE PELVIC ABSCESS. SHE WAS ADMITTED AND UNDERWENT A CT GUIDED CATHETER PLACEMENT IN AN ATTEMPT TO DRAIN THE ABSCESSES. THE PATIENT WAS DISCHARGED HYPOTENSIVE WITH ACUTE ABDOMEN ON (B)(6) 2011 AND UNDERWENT AN EXPLORATORY LAPAROTOMY, WITH THE FINDINGS OF A 2MM LEFT ILEAC ARTERY INJURY. SHE WAS ALSO NOTED TO HAVE A CAUTERY EFFECT AND INJURY ON THE AORTA. BOTH THE LEFT ILIAC ARTERY AND AORTA WERE REPAIRED. SECONDARY TO THE ACUTE BLOOD LOSS, THE PATIENT WAS SENT BACK TO THE ICU, WHERE THE SHE REMAINED MECHANICALLY VENTILATED. ON (B)(6) 2011, THE PATIENT EXPERIENCED AN EPISODE OF FAIRLY SUDDEN SHOCK AND VASCULAR COMPROMISE. SHE WAS RUSHED BACK TO THE OPERATING ROOM AGAIN AND UNDERWENT A RE-EXPLORATION OF HER ABDOMEN, WITH FINDINGS OF AN AORTIC RUPTURE IN THE SAME AREA AS THE PREVIOUSLY NOTED CAUTERY INJURY, AND WAS REPAIRED AGAIN. SHE RECEIVED EXTENSIVE VOLUMES OF FLUID, BLOOD, PLATELETS AND FRESH FROZEN PLASMA THROUGHOUT THE COURSE OF HER HOSPITALIZATION. SHE WAS AGAIN MAINTAINED ON A VENTILATOR FOLLOWING SURGERY AND WAS FOLLOWED BY THE RENAL SERVICE, PULMONARY SERVICE, AND INFECTIOUS DISEASE SERVICE UNTIL THE POINT SHE WAS FINALLY EXTUBATED. SHE WAS DISCHARGED HOME ON (B)(6) 2011. THE PATIENT REPRESENTED TO THE HOSPITAL ON (B)(6) 2011 COMPLAINING OF LOWER ABDOMINAL PAIN. A CT-SCAN REVEALED AN EXTRAVASATION OF ARTERIAL CONTRAST AT THE LEVEL OF THE AORTIC BIFURCATION, WITH POSSIBLE PSEUDOANEURYSM OR ARTERIAL PERFORATION. THE PATIENT UNDERWENT ANOTHER EXPLORATORY LAPAROTOMY. SHE WAS NOTED DURING THAT SURGERY TO HAVE AN ISSUE WITH THE LEFT ILIAC, CLOSE TO THE AREA OF PRIOR DISRUPTION, BUT NOT RELATED TO A PRIOR REPAIR. BECAUSE OF THE EXTENT OF THE INJURY AND DENSE REACTIVE TISSUE TO THE AORTIC AND ILIAC VESSELS AND THE AMOUNT OF BLOOD AND INFLAMMATORY RESPONSE, THE SURGEON DECIDED TO DO AN EXTRA ANATOMIC \"AXILLOBIFEONORAL\" BYPASS. THE ANATOMIC BYPASS INVOLVES THE LIGATION OF THE AORTA AND THE BILATERAL ILEAC VESSELS. A GRAFT HAD TO BE TAKEN FROM HER SUBCLAVIAN AXILLARY VEINS THROUGH AN INCISION INTO HER LEFT CLAVICLE AREA. A GRAFT ANASTOMOSIS WAS THEN PERFORMED. THE PATIENT WAS SENT BACK TO ICU AND SLOWLY IMPROVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011." }, { "mdr_text_key": "18700692", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THERE WAS NO ALLEGATION IN THE PATIENT'S OPERATIVE REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2010 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED INJURIES DURING A DA VINCI SI SURGICAL PROCEDURE RESULTING IN SUBSEQUENT POST-SURGICAL COMPLICATIONS." } ], "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": "04/09/2015" } ] }