{ "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": "2955842-2015-00495", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20150326", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130225", "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": "20150326", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "203083", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150326", "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", "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": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20150326", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "58 YR", "patient_sex": "", "patient_weight": "62", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Death", "Diarrhea", "Purulent Discharge", "Nausea", "Thrombosis", "Vomiting", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20150226", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4636357", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150226", "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": "13108885", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THE OPERATIVE REPORT DOES NOT CONTAIN ANY INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THE DATE OF THE PATIENT'S DEMISE IS UNKNOWN. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE INJURIES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S OPERATIVE COMPLICATIONS AND DEMISE IS UNKNOWN." }, { "mdr_text_key": "5573080", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY AND EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2013 FOR POORLY DIFFERENTIATED CARCINOMA OF PROBABLE ENDOMETRIAL ORIGIN, POSTMENOPAUSAL BLEEDING, ENLARGED UTERUS AND EXTENSIVE INTRAPERITONEAL ADHESIONS. 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 PATIENT'S MEDICAL RECORDS, A CYSTOSCOPY PERFORMED AT THE CONCLUSION OF THE DA VINCI SURGICAL PROCEDURE SHOWED GOOD EFFLUX OF URINE BILATERALLY FROM THE URETERAL OSTIA, AND NO VISIBLE BLADDER DEFECTS. NO OPERATIVE COMPLICATIONS WERE NOTED, AND THE ESTIMATED BLOOD LOSS WAS 150 ML. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. THE DISCHARGE SUMMARY WAS NOT AVAILABLE FOR REVIEW. ON (B)(6) 2013, THE PATIENT PRESENTED TO AN ER WITH COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, VOMITING, AND DIARRHEA. A CT-SCAN SHOWED MULTIPLE DILATED LOOPS OF FLUID FILLED BOWEL CONSISTENT WITH ILEUS, AND A LARGE PELVIC ABSCESS WHICH MEASURED GREATER THAN 12 CM IN DIAMETER THAT APPEARED ADJACENT TO THE SIGMOID COLON. IV ANTIBIOTICS WERE INITIATED. ON (B)(6) 2013, THE PATIENT UNDERWENT CT-ASSISTED DRAINAGE OF A PELVIC ABSCESS, WITH 150 ML OF FOUL SMELLING BROWN PURULENT FLUID OBTAINED. A CULTURE OF THE FLUID REVEALED A HEAVY GROWTH OF MIXED ANAEROBES, INCLUDING GRAM NEGATIVE RODS. PHYSICAL THERAPY WAS INITIATED TO ASSIST WITH REHAB, AND DIET AND ACTIVITY WERE GRADUALLY ADVANCED. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2013. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE ER AGAIN WITH COMPLAINTS OF NAUSEA, VOMITING, AND LOWER ABDOMINAL PAIN. A FOLLOW-UP CT-SCAN DEMONSTRATED BILATERAL PELVIC SIDEWALL FLUID COLLECTIONS THAT HAD INCREASED IN SIZE FROM THE PREVIOUS CT-SCAN. ALSO NOTED WAS BILATERAL PELVOCALIECTASIS [HYDRONEPHROSIS] SUGGESTIVE OF COMPRESSION OF THE DISTAL URETERS FROM THE PELVIC FLUID COLLECTIONS. THE PATIENT WAS ADMITTED FOR SUPPORTIVE CARE AND SYMPTOMATIC MANAGEMENT. ON (B)(6) 2013, THE PATIENT UNDERWENT A CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAMS, AND BILATERAL URETERAL STENT PLACEMENT FOR BILATERAL URETERAL OBSTRUCTION. PER THE OPERATIVE REPORT, BOTH THE LEFT AND RIGHT COLLECTING SYSTEMS APPEARED MILDLY DILATED, WITH NO FILLING DEFECTS NOTED. ON (B)(6) 2013, THE PATIENT UNDERWENT REMOVAL OF THE PREVIOUS DRAINAGE CATHETER, IN ADDITION TO CT-ASSISTED FLUID REMOVAL OF A COLLECTION IN THE RIGHT ILIOPSOAS REGION. THIRTY-FIVE ML OF CLEAR FLUID WAS REMOVED, AND THE COLLECTION WAS NOTED TO HAVE THE APPEARANCE OF A LYMPHOCELE. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2013. ON (B)(6) 2013, THE PATIENT PRESENTED TO AN ER WITH COMPLAINTS OF INCREASING ABDOMINAL DISCOMFORT WITHOUT FLATUS OR BOWEL MOVEMENT FOR 3 DAYS, NAUSEA, VOMITING, AND WEAKNESS FOLLOWING A FALL. AN ULTRASOUND OF THE RIGHT LEG REVEALED EVIDENCE OF DVT (DEEP VEIN THROMBOSIS) FROM JUST ABOVE THE RIGHT KNEE, EXTENDING INTO THE RIGHT PELVIS. A CT-SCAN OF THE PATIENT'S ABDOMEN AND PELVIS SHOWED MULTIPLE LOOPS OF PROXIMAL AND MID-SMALL BOWEL CONSISTENT WITH A SMALL BOWEL OBSTRUCTION, INCREASED RETROPERITONEAL ADENOPATHY, AND INCREASED SOFT TISSUE MASSES THROUGHOUT THE PELVIS SUSPECTED TO BE PERITONEAL IMPLANTS AS WELL AS METASTATIC IMPLANTS. AN NG TUBE WAS PLACED, AND A LOVENOX TO COUMADIN BRIDGE WAS INITIATED. SURGICAL INTERVENTION OF THE SMALL BOWEL OBSTRUCTION WAS NOT AN OPTION, AS IT WAS FELT TO BE DUE TO A PROGRESSION OF THE PATIENT'S ENDOMETRIAL CANCER. THE POOR PROGNOSIS WAS DISCUSSED WITH THE PATIENT AND HER FAMILY, AND SHE WAS SUBSEQUENTLY TRANSFERRED TO A HOSPICE CARE FACILITY. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2013. THE DATE OF THE LAST MEDICAL RECORD PROVIDED WAS (B)(6) 2013." } ], "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": "" } ] }