{ "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": "2955842-2023-16946", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230711", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200815", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "IT", "manufacturer_contact_area_code": "408", "date_added": "20230711", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1586812", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230711", "brand_name": "DA VINCI", "generic_name": "DA VINCI", "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": "N/A", "catalog_number": "N/A", "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": "", "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": "20230711", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Insufficient Information", "Hemorrhage/Blood Loss/Bleeding", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20230612", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17299124", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230612", "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": "319010020", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION OR REPORT THAT DA VINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION AND THE ROOT CAUSE OF THE CUSTOMER REPORTED POSTOPERATIVE INCIDENT CANNOT BE DETERMINED. ARTICLE CITATION: (B)(6). ROBOT-ASSISTED SPLEEN PRESERVING DISTAL PANCREATECTOMY (RA-SPDP): A SINGLE CENTER EXPERIENCE. MINI-INVASIVE SURG (B)(6) 2020. AVAILABLE AT: (B)(6)." }, { "mdr_text_key": "319010021", "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, ¿ROBOT-ASSISTED SPLEEN PRESERVING DISTAL PANCREATECTOMY (RA-SPDP): A SINGLE CENTER EXPERIENCE,¿ THE FOLLOWING EVENTS WERE REPORTED: A RETROSPECTIVE DATABASE ANALYSIS OF 54 PATIENTS WHO RECEIVED RA-SPDP BETWEEN APRIL 2008 TO OCTOBER 2017 AT A SINGLE INSTITUTION SHOWED OPERATIVE COMPLICATIONS AS FOLLOWS: INTRA-OPERATIVELY OUTCOME MEASURES SHOWED FOUR (7.4%) PATIENTS RECEIVED BLOOD TRANSFUSION, THE MEDIAN NUMBER OF BLOOD UNIT TRANSFUSED PER PATIENT WAS 1 UNIT. ADDITIONALLY, THE ARTICLE STATES, \"IN THREE PATIENTS, THE SPLENIC VESSELS HAD TO BE RECONSTRUCTED TO AVOID A WARSHAW PROCEDURE OR A SPLENECTOMY. FURTHERMORE, THE ARTICLE NOTES, \"THERE WERE TWO ELECTIVE RECONSTRUCTIONS, CAUSED BY DIFFICULT DETACHMENT OF THE SPLENIC VESSELS FROM THE TUMOR AND ONE URGENT RECONSTRUCTION DUE TO INJURY TO THE SPLENIC VEIN.\" POST-OPERATIVE OUTCOME MEASURES SHOWED FIVE PATIENTS REQUIRED POST-OPERATIVE BLOOD TRANSFUSIONS AND 21 PATIENTS HAD GRADE 0 CLAVIEN-DINDO COMPLICATIONS, 32 PATIENTS DEVELOPED GRADE I-II COMPLICATIONS AND 1 PATIENT HAD A CLAVIEN-DINDO GRADE III-IV COMPLICATION. IT WAS MENTIONED THAT TWO PATIENTS DEVELOPED SEVERE POST-OPERATIVE COMPLICATIONS. BOTH PATIENTS \"REQUIRED REPEAT SURGERY TO ADDRESS THE BLEEDING AND SPLENIC INFRACTION.\" THE FIRST PATIENT WAS RE-OPERATED DURING THE INITIAL HOSPITAL STAY AND THE BLEEDING WAS CONTROLLED. ALSO, THE SPLEEN WAS PRESERVED. PER THE ARTICLE, \"THE SECOND PATIENT WAS RE-OPERATED AT THE TIME OF HOSPITAL READMISSION.\" THERE WERE NO GRADE C POST-OPERATIVE PANCREATIC FISTULA (POPF) AND 19 PATIENTS WERE OBSERVED WITH GRADE B POPF. OVERALL, FOUR PATIENTS WERE READMITTED POST-OPERATIVELY, WITH NO FURTHER INFORMATION OTHER THAN ABOVE MENTIONED. THERE WAS NO REPORT OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES MALFUNCTIONS IN THE ARTICLE. INTUITIVE SURGICAL, INC, (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN PATIENT DEMOGRAPHIC INFORMATION AND ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED." } ], "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": "" } ] }