{ "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": "2955842-2023-17051", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230713", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20220813", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230714", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "699392", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230713", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601", "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": "R", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20230713", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Nausea", "Urinary Retention", "Unspecified Tissue Injury", "Nausea", "Urinary Retention", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230615", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17322321", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230615", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "319108373", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿ROBOTIC SINGLE-PORT SURGERY: PRELIMINARY EXPERIENCE IN GENERAL SURGERY\", THE FOLLOWING EVENTS WERE REPORTED. A REVIEW OF THE DATABASE WAS PERFORMED ON THE PATIENTS WHO UNDERWENT SINGLE INCISION SURGERY WITH THE DA VINCI SP SURGICAL SYSTEM FROM JULY 2019 TO SEPTEMBER 2021 WAS PERFORMED ACCORDING TO THE ARTICLE. PROCEDURES PERFORMED INCLUDED 141 SINGLE PORT CHOLECYSTECTOMY (SP-C) AND 77 SINGLE PORT TRANSABDOMINAL PREPERITONEAL INGUINAL HERNIA REPAIR (SP-TAPP). MOST OF THE PATIENTS WERE DISCHARGED THE SAME DAY. THERE WERE TWO PATIENTS REQUIRED ADMISSION IN THE SP-TAPP COHORT AND WERE THE COMBINED CASES WITH THE UROLOGY TEAM (PARTIAL NEPHRECTOMY AND PROSTATECTOMY). IN THE SP-C GROUP, 2 PATIENTS WERE ADMITTED POSTOPERATIVELY DUE TO PERSISTENT NAUSEA AND VOMITING. ALL THE POST-OPERATIVE COMPLICATIONS WERE CLAVIEN-DINDO GRADE II OR LESS AND INCLUDED 3 SEROMAS (RESOLVED SPONTANEOUSLY), 2 PROLONGED POSTOPERATIVE ILEUS (MANAGED CONSERVATIVELY), 1 URINARY RETENTION (REQUIRED FOLEY CATHETER), AND 1 URINARY TRACT INFECTION (ANTIBIOTIC TREATMENT). THERE WERE NO MAJOR COMPLICATIONS, URGENT REOPERATIONS, OR MORTALITY. THREE PATIENTS WERE READMITTED (1.4%), 2 FOR PROLONGED POSTOPERATIVE ILEUS (1 SP-C AND 1 SP-TAPP), AND 1 FOR A URINARY RETENTION IN THE SP-C GROUP. THERE WERE 3 (1.4%) PORT SITE HERNIAS MENTIONED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED." }, { "mdr_text_key": "319108374", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION AND THE ROOT CAUSE OF THE CUSTOMER REPORTED POSTOPERATIVE INCIDENTS CANNOT BE DETERMINED. ARTICLE CITATION: BIANCO FM, DREIFUSS NH, CHANG B, ET AL. ROBOTIC SINGLE-PORT SURGERY: PRELIMINARY EXPERIENCE IN GENERAL SURGERY. INT J MED ROBOT. 2022;E2453. HTTPS://DOI.ORG/10.1002/RCS.2453." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }