{ "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": "2955842-2013-00243", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130122", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20090209", "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": "20130122", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "29267", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130122", "brand_name": "DA VINCI S", "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": [ "Torn Material" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "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": "20130122", "sequence_number_treatment": [ "DA VINCI S SYSTEM AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "37 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Cyst(s)", "Diarrhea", "Fever", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Nausea", "Injury" ] } ], "distributor_city": "", "date_report": "20121217", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2925169", "removal_correction_number": "", "number_devices_in_event": "", "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": "3217303", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PER LEGAL SUMMONS RECEIVED ON (B)(4) 2012, IT WAS ALLEGED THAT THE PATIENT HAD A DA VINCI S HYSTERECTOMY SURGERY ON (B)(6) 2009 TO REMOVE OVARIAN FIBROID TUMORS. FIVE WEEKS AFTER SURGERY, THE PATIENT BEGAN FEELING FEVERISH AND NAUSEOUS AND HAD DIARRHEA. IT WAS ALLEGED THE PATIENT HAD NOT ENGAGED IN SEXUAL INTERCOURSE SINCE THE SURGERY. AT THAT TIME, IT WAS ALLEGED THE PATIENT ENGAGED IN SEXUAL INTERCOURSE WITH HER HUSBAND AND EXPERIENCED LIGHT BLEEDING. WHEN THE PATIENT USED THE BATHROOM THEREAFTER, THE PATIENT HEARD A POP AND ALLEGEDLY SAW APPROXIMATELY AN INCH OF INTESTINES COMING OUT OF HER VAGINA. THE PATIENT WAS ADMITTED AT THAT TIME TO (B)(6). A DIFFERENT SURGEON PERFORMED EMERGENCY OPEN LAPAROTOMY SURGERY. WHILE OPERATING, A MASSIVE INFECTION WITH CYSTS AND ADHESIONS ENCAPSULATING THE FALLOPIAN TUBE AND OVARY WAS FOUND AND THE RIGHT OVARY HAD TO BE REMOVED AS A RESULT. ADDITIONALLY, THE INFECTION DETERIORATED THE VAGINAL CUFF TISSUE THAT HAD BEEN SEWN DURING THE DA VINCI S HYSTERECTOMY CAUSING THE CUFF TO TEAR LEADING TO A SMALL BOWEL EVISCERATION. THE INFECTED TISSUE WAS REMOVED AND VAGINAL CUFF RE-SEWN. THE PATIENT STAYED IN THE HOSPITAL FIVE DAYS." }, { "mdr_text_key": "10486322", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, THE SURGEON WAS CONTACTED TO REQUEST ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT. IT WAS INDICATED THE SURGERY OCCURRED ON (B)(6) 2009 AT 11 AM AND NO MALFUNCTIONS OCCURRED WITH THE DA VINCI S SYSTEM, INSTRUMENTS OR ACCESSORIES; NO COMPLICATIONS WERE NOTED DURING THE SURGERY. NO ARCING OCCURRED DURING THE PROCEDURE, WHILE USING BIPOLAR ENERGY. THE PHYSICIAN INFORMED THAT A RECOMMENDATION HAD BEEN MADE TO WAIT EIGHT WEEKS BEFORE RESUMING SEXUAL INTERCOURSE. THE PATIENT ENGAGED IN SEXUAL INTERCOURSE PRIOR TO RECOMMENDED EIGHT WEEKS, THE PATIENT WAS ADMITTED FOR EVISCERATION OF THE BOWEL ON (B)(6) 2009 AT (B)(6) WHERE CARE WAS PROVIDE BY A DIFFERENT SURGEON. A REVIEW OF SYSTEM LOGS FOR THE SYSTEM USED IN THE PROCEDURE DID NOT PRODUCE ANY DATA FOR THE GIVEN SYSTEM AT THE TIME PERIOD INDICATED. THE SURGERY WAS NOT FOUND IN THE SYSTEM LOGS AND COULD NOT BE CHECKED." } ], "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": "" } ] }