{ "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": "2955842-2015-00252", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150206", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121023", "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": "20150206", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "87748", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150206", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20150206", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "60 YR", "patient_sex": "", "patient_weight": "82", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Anemia", "Death", "Edema", "Fever", "Unspecified Infection", "Renal Failure", "Urinary Tract Infection", "Chills", "Ascites" ] } ], "distributor_city": "", "date_report": "20150108", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4491776", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150108", "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": "21237957", "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 WITH BILATERAL SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS AND BILATERAL PELVIC LYMPH NODE DISSECTION ON (B)(6) 2012 FOR ENDOMETRIAL CARCINOMA AND SIGNIFICANT PELVIC ADHESIVE DISEASE. 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. PER THE DA VINCI OPERATIVE REPORT, NO COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS 50 ML. POST-OPERATIVELY, THE PATIENT EXPERIENCED ANEMIA AND ACUTE RENAL FAILURE. SHE RECEIVED 3 UNITS OF PACKED RED BLOOD CELLS, AND HER ANEMIA SUBSEQUENTLY RESOLVED AND HER CREATININE IMPROVED. THERE WAS ALSO CONCERN FOR CONGESTIVE HEART FAILURE, ALTHOUGH AN ECHOCARDIOGRAM REVEALED A NORMAL EJECTION FRACTION. THE PATIENT WAS CONTINUED ON MODERATE FLUIDS AND WAS GIVEN A DOSE OF LASIX; AFTER THIS, HER SYMPTOMS IMPROVED AND HER EDEMA BEGAN TO IMPROVE. DUE TO LOW PLATELETS OF 59,000, THE PATIENT WAS GIVEN ONE DOSE OF DESMOPRESSIN ACETATE (DDAVP). THE PATIENT WAS ALSO STARTED ON CIPRO, AN ANTIBIOTIC, FOR A UTI. DUE TO AN IMPENDING HURRICANE, THE PATIENT DESIRED TO GO HOME. SHE REFUSED AN ABDOMINAL ULTRASOUND THAT WAS TO BE DONE TO EVALUATE HER ELEVATED LIVER FUNCTION TESTS. SHE WAS ALSO ADVISED TO FOLLOW UP WITH A PHYSICIAN TO FURTHER EVALUATE THESE FINDINGS. THE PATIENT WAS HOSPITALIZED (B)(6) 2012. THE PATIENT PRESENTED TO AN ER ON (B)(6) 2012 WITH COMPLAINTS OF FEVER, CHILLS, AND INCREASING ABDOMINAL PAIN. A CT-SCAN OF THE ABDOMEN AND PELVIS SHOWED MODERATE ASCITES WITHIN THE ABDOMEN AND PELVIS WITH NODULAR CONTOUR OF THE LIVER, FEATURES SUGGESTIVE OF CIRRHOSIS. DIFFUSE ANASARCA, EXTREME GENERALIZED EDEMA, WAS ALSO NOTED WITHIN THE SOFT TISSUE, WITH ATELECTASIS VERSUS EARLY INFILTRATE WITHIN THE LUNG BASES. ANTIBIOTICS WERE INITIATED AND APPROPRIATE CONSULTS OBTAINED. DISCHARGE DIAGNOSES INCLUDED UTI AND CIRRHOSIS. THE PATIENT WAS HOSPITALIZED (B)(6) 2012, WITH HOME HEALTH CARE PLANNED UPON DISCHARGE. THE PATIENT WAS READMITTED TO A HOSPITAL ON (B)(6) 2012, WITH A WOUND INFECTION AND WORSENING ANASARCA SECONDARY TO CIRRHOSIS. THE PATIENT ALSO EXPERIENCED ACUTE RENAL FAILURE AND BRIEFLY UNDERWENT DIALYSIS. PALLIATIVE CARE WAS CONSULTED, AND THE FAMILY EVENTUALLY DECIDED ON COMFORT CARE MEASURES ONLY. ON (B)(6) 2012, THE PATIENT WAS TRANSITIONED TO INPATIENT HOSPICE CARE WITH A POOR PROGNOSIS. SHE WAS SEEN LATER THAT DAY FOR SYMPTOM MANAGEMENT AT END OF LIFE. PER THE AVAILABLE MEDICAL RECORDS PROVIDED, AN ADDENDUM TO THE DEATH SUMMARY WAS FILED ON (B)(6) 2012. THE DEATH SUMMARY WAS NOT PROVIDED. THE EXACT DATE OF DEATH AND CAUSE OF DEATH ARE UNKNOWN. THE DATE OF THE LAST MEDICAL RECORD PROVIDED WAS (B)(6) 2012." }, { "mdr_text_key": "21442876", "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 POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. 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. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2012. 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 COMPLICATIONS AND SUBSEQUENT DEMISE. 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 AND SUBSEQUENT DEMISE IS UNKNOWN." } ], "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": "" } ] }