{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2024-17617", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240802", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240621", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20240802", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211012", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "984006", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240802", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-45", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250820", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20240802", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "65 YR", "patient_sex": "Male", "patient_weight": "57 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Fever", "Hemorrhage/Blood Loss/Bleeding", "Dizziness", "Fever", "Hemorrhage/Blood Loss/Bleeding", "Dizziness" ] } ], "distributor_city": "", "date_report": "20240708", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19891696", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240708", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "348316765", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE PERFORMED, THE PATIENT EXPERIENCED BLOODY STOOLS ON THE SAME DAY POST-SURGERY. ON POST-OPERATIVE DAY ONE, A COLONOSCOPY FOUND BLEEDING AT THE ANASTOMOSIS SITE. HEMOSTATIC CLIPS WERE APPLIED, AND THE BLEEDING WAS RESOLVED. THERE WERE NO ABNORMAL BOWEL MOVEMENTS AFTER EATING, AND THE SUBJECT WAS DISCHARGED ON POST-OPERATIVE DAY SEVEN. ON POST-OPERATIVE DAY NINE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF BLOODY STOOLS, DIZZINESS, AND RESPIRATORY DISCOMFORT. TREATMENT INCLUDED FASTING, ADMINISTRATION OF HEMOSTATIC INJECTIONS, INTRAVENOUS DRIP, AND BLOOD TRANSFUSION. A FEVER WAS IDENTIFIED, AND BLOOD CULTURES WERE DRAWN. A CONSULTATION WITH THE COLORECTAL DEPARTMENT RECOMMENDED CONTINUING THE PREVIOUS TREATMENT AND ARRANGING FOR HOSPITALIZATION. ON POST-OPERATIVE DAY 10, THE PATIENT WAS ADMITTED TO THE WARD AND CONTINUED WITH FASTING, HEMOSTATIC INJECTIONS, ANTIBIOTICS AND A BLOOD TRANSFUSION. ON POST-OPERATIVE DAY 11, THE PATIENT WAS STILL EXPERIENCING BLOODY STOOLS, AND THE PHYSICIAN STATED THERE WAS NO NEED FOR FURTHER SURGERY AT THE MOMENT, AS THE ANASTOMOSIS SITE IS HEALING POORLY AND CAUSING BLEEDING. THE PHYSICIAN ORDERED OBSERVATION AND A REPEAT COLONOSCOPY. HEMOSTATIC INJECTIONS WERE CONTINUED, AND THE STOOL WAS CHARACTERIZED AS BLOODY AND BLACK. THE ATTENDING PHYSICIAN ORDERED THE PATIENT TO CONTINUE FASTING AND RECEIVE NUTRITIONAL INJECTIONS. THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "348316766", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE. THE SYSTEM WAS NOT CONNECTED TO ONSITE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }