{ "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": "2955842-2024-19725", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240930", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240506", "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": "20240930", "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": "40523", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240930", "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": "00886874114605", "udi_public": "(01)00886874114605", "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": "20250821", "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": "20240930", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "68 YR", "patient_sex": "Male", "patient_weight": "78 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Failure to Anastomose", "Abdominal Pain", "Bacterial Infection", "Failure to Anastomose", "Abdominal Pain", "Bacterial Infection" ] } ], "distributor_city": "", "date_report": "20240902", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20337669", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240902", "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": "353033696", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT, WHO WAS ENROLLED IN A STUDY, UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE. APPROXIMATELY THREE MONTHS LATER, THE PATIENT RETURNED TO THE HOSPITAL FOR A PLANNED ILEOSTOMY TAKEDOWN SURGICAL PROCEDURE AND WAS DISCHARGED ON POST-OPERATIVE DAY #4. ON POST-OPERATIVE DAY #11, DURING A FOLLOW-UP VISIT, THE PATIENT COMPLAINED OF UPPER ABDOMINAL PAIN WITH TENDERNESS UPON PALPATION. IT IS UNKNOWN IF THE PATIENT WAS ABLE TO PASS STOOL. A KUB X-RAY SHOWED INTESTINAL GAS. GASTRIC MEDICATION WAS PRESCRIBED AND SCHEDULED A FOLLOW-UP IN A WEEK. DUE TO PERSISTENT ABDOMINAL PAIN AND COLD SWEATS, THE PATIENT VISITED THE EMERGENCY ROOM IN THE SAME EVENING. THE ABDOMEN WAS SOFT BUT PAINFUL UPON PRESSURE. BLOOD TESTS SHOWED ELEVATED WBC AND CRP, AND LOW POTASSIUM. KUB AND ABDOMINAL CT SCANS INDICATED GAS AND FLUID IN THE UPPER ABDOMEN, SUGGESTING A MINOR ANASTOMOTIC LEAK. THE RECTAL DEPARTMENT WAS CONSULTED AND RECOMMENDED FASTING, IV FLUIDS, ANTIBIOTICS, MONITORING VITAL SIGNS, AND HOSPITAL ADMISSION. THE NEXT DAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL, RECEIVING ANTIBIOTICS AND NUTRITIONAL IV, AND FASTING. ON POST-OPERATIVE DAYS #13 THROUGH #17, THE PATIENT REPORTED PERSISTENT BUT NOT WORSENING ABDOMINAL PAIN AND CONTINUED FASTING AND RECEIVING NUTRITIONAL IV. ON POST-OPERATIVE DAY #18, THE PATIENT WAS FOUND TO BE SLIGHTLY SHORT OF BREATH WITH A BLOOD OXYGEN SATURATION AROUND 89-91%. THE PATIENT WAS PLACED ON A NASAL CANNULA WITH OXYGEN AT 3L/MIN. ON POST-OPERATIVE DAY #21, DUE TO ABDOMINAL DISCOMFORT, A CT SCAN WAS ORDERED, FOLLOWED BY A DRAINAGE PROCEDURE, RESULTING IN THE PLACEMENT OF TWO DRAINAGE TUBES, IN THE LOWER LEFT ABDOMEN. ON POST-OPERATIVE DAY #22 THOUGH DAY #23, THE PATIENT REMAINED ON OXYGEN, CONSCIOUS BUT FATIGUED AND THE TWO DRAINAGE TUBES IN THE LEFT ABDOMEN WERE DRAINING SMOOTHLY. ON POST-OPERATIVE DAY #25 THROUGH DAY #26, THE PATIENT INSISTED THAT THE NASAL CANNULA WAS RESULTING IN INSUFFICIENT OXYGEN, SO THE CARE TEAM SWITCHED TO A VENTURI MASK. THE DRAINAGE TUBES WERE DISCHARGING PURULENT AND PALE-YELLOW FLUID, AND NUTRITIONAL IV CONTINUED. ON POST-OPERATIVE DAY #29, X-RAYS SHOWED PULMONARY EDEMA AND LABS INDICATED LOW BLOOD ALBUMIN AND SODIUM LEVELS. THREE DAYS OF ALBUMIN AND DIURETICS WERE PRESCRIBED, AND ADDITIONAL SODIUM WAS ADDED TO THE DIET. ON POST-OPERATIVE DAY #32, A TUBE WAS INSERTED TO DRAIN FLUID FROM THE LEFT LUNG. ON POST-OPERATIVE DAY #34, THE LEFT LOWER ABDOMINAL DRAIN WAS REMOVED. A CHEST X-RAY SHOWED INFILTRATION IN BOTH LUNGS, A DIURETIC WAS PRESCRIBED. ON POST-OPERATIVE DAY #35, THE LEFT CHEST TUBE WAS REMOVED. ON POST-OPERATIVE DAY #37, A FEVER WAS NOTED. IT WAS MONITORED WITHOUT MEDICAL INTERVENTION. ON POST-OPERATIVE DAY #39, TWO UNITS OF BLOOD WERE ADMINISTERED FOR ANEMIA. ON POST-OPERATIVE DAY #40, A BLADDER ULTRASOUND INDICATED A POST-VOID RESIDUAL OF 473 ML. A SINGLED CATHETERIZATION WAS PERFORMED AND YIELDED 500ML OF URINE. MEDICATION WAS PRESCRIBED. ON POST-OPERATIVE DAY #41, THE PATIENT WAS DISCHARGED IN STABLE CONDITION." }, { "mdr_text_key": "353033697", "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 AT THIS TIME." } ], "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": "" } ] }