{ "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": "2955842-2013-03177", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130201", "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": "413079", "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": "", "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": "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM, INSTRUMENTS, ACCESSORIES & ES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Nausea", "Discomfort" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305909", "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": "17162189", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A MEDICAL RECORDS SUMMARY REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI RIGHT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2013. THE INFORMATION RECEIVED ALLEGES THAT THE PATIENT'S OPERATIVE REPORT DESCRIBED THAT THE PATIENT HAD A MASS THAT ADHERED TO THE ILIAC VEIN AND DURING DISSECTION THE ILIAC VEIN WAS TORN. THE PROCEDURE WAS CONVERTED TO AN OPEN LAPAROTOMY. A VASCULAR SURGEON WAS CONSULTED TO REPAIR THE PATIENT'S VESSEL. THE MEDICAL SUMMARY AS PROVIDED INDICATES THAT DURING THE SURGICAL PROCEDURE THE DAMAGE TO THE PATIENT'S VESSEL WAS NOTED DURING DISSECTION USING A HARMONIC SHEARS INSTRUMENT. THE OPEN LAPAROTOMY PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE WELL. DURING THE PATIENT'S HOSPITALIZATION, THE PATIENT WAS DIAGNOSED WITH RIGHT COMMON FEMORAL DEEP VEIN THROMBUS AND WAS TREATED WITH MEDICATIONS TO TREAT HER CONDITION. ON THE 7TH DAY OF THE PATIENT'S HOSPITALIZATION THE PATIENT WAS ANEMIC AND WAS GIVEN TWO UNITS OF RED BLOOD CELL. ON THE 11TH DAY THE PATIENT'S PAIN WAS WELL CONTROLLED, TOLERATING A REGULAR DIET, PASSING FLATUS AND BOWEL MOVEMENTS, AMBULATING WITHOUT DIFFICULTY AND HAD IMPROVEMENT IN HER LEG PAIN. THE PATIENT'S EXERTIONAL DYSPNEA IMPROVED AND SHE WAS DEEMED STABLE FOR DISCHARGE. DURING THE PATIENT POST-OPERATIVE FOLLOW-UP ON (B)(6) 2013, THE PATIENT INDICATED THAT SHE WAS DOING MUCH BETTER AND THAT HER MAIN CONCERN WAS THAT SHE WAS BLEEDING FROM HER MIDLINE ABDOMINAL INCISION. ON (B)(6) 2013, DURING A ROUTINE FOLLOW UP THE PATIENT COMPLAINED OF ABDOMINAL DISCOMFORT, LOSS OF APPETITE AND NAUSEA. ON (B)(6) 2013, THE PATIENT UNDERWENT AN ABDOMINAL CT SCAN AND IT WAS NEGATIVE. DURING A ROUTINE FOLLOW-UP ON (B)(6) 2013, THE PATIENT WAS FOUND TO BE RECOVERING WELL." }, { "mdr_text_key": "17363963", "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. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(4) 2013, FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S SUSTAINED AN INJURY DURING A DA VINCI SI RIGHT SALPINGO-OOPHORECTOMY PROCEDURE." } ], "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": "" } ] }