{ "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": "2955842-2022-11990", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220603", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "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", "Foreign", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20220603", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2211795", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220603", "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": "380601-34", "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": "20250803", "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": "20220603", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Hemorrhage/Blood Loss/Bleeding", "Post Operative Wound Infection", "Abscess", "Hemorrhage/Blood Loss/Bleeding", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20220504", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14594239", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220504", "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": "293292339", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL ONCOLOGY ARTICLE TITLED, ¿OPERATIVE AND SURVIVAL OUTCOMES OF ROBOTIC-ASSISTED SURGERY FOR COLORECTAL CANCER IN ELDERLY AND VERY ELDERLY PATIENTS: A STUDY IN A TERTIARY HOSPITAL IN SOUTH KOREA¿ (CUELLAR-GOMEZ, H., RUSLI, S. M., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED. A RETROSPECTIVE STUDY WAS PERFORMED TO EVALUATE THE POSTOPERATIVE AND SURVIVAL OUTCOMES OF ROBOTIC-ASSISTED COLORECTAL CANCER SURGERY (RACS) IN ELDERLY PATIENTS. ALL PATIENTS =75 YEARS WHO UNDERWENT A ROBOTIC-ASSISTED CURATIVE RESECTION AT A SINGLE CENTER BETWEEN JANUARY 2007 AND JANUARY 2021 WERE EXTRACTED FROM A PROSPECTIVELY MAINTAINED COLORECTAL CANCER DATABASE. PER THE ARTICLE, POST-OPERATIVE COMPLICATIONS WERE REPORTED ACCORDING TO THE MODIFIED CLAVIEN-DINDO CLASSIFICATION, TOGETHER WITH THE TYPE OF COMPLICATION, LENGTH OF HOSPITAL STAY (LOS), AND REOPERATION RATE (PATIENTS RE-OPERATED WITHIN 30 DAYS FROM INITIAL SURGERY). MAJOR COMPLICATIONS WERE OBSERVED IN 2.1% OF PATIENTS AND THE 30-DAY MORTALITY RATE WAS 0%. REPORTED COMPLICATIONS INCLUDED: ANASTOMOTIC LEAKAGE (4); INTRAABDOMINAL ABSCESS (4); WOUND INFECTION (2); ILEUS (14); BLEEDING (1); PULMONARY (UNSPECIFIED ISSUES) (2); AND RE-OPERATION (2) FOR ANASTOMOTIC LEAKAGE, AND BOTH NEEDED HARTMANN¿S PROCEDURE. POSTOPERATIVE COMPLICATIONS WERE NOT STATISTICALLY DIFFERENT BETWEEN THE ELDERLY AGE GROUPS. PER THE AUTHORS, RACS IS SAFE, FEASIBLE, AND WELL TOLERATED FOR ELDERLY AND VERY ELDERLY PATIENTS. ELDERLY PATIENTS DEMONSTRATED POSTOPERATIVE CLINICAL OUTCOMES AND COMPLICATIONS COMPARABLE TO SIMILAR STUDIES. THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A SPECIFIC DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO ISI FOR FAILURE ANALYSIS EVALUATION. ISI MADE THE REQUIRED ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE ARTICLE CORRESPONDENCE; HOWEVER, THERE WAS NO RESPONSE RECEIVED." }, { "mdr_text_key": "293292340", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE REPORTED COMPLICATIONS AFTER UNDERGOING A DA VINCI-ASSISTED SURGERY FOR COLORECTAL CANCER, CANNOT BE DETERMINED OR IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SYSTEM LOG REVIEW COULD NOT BE CONDUCTED DUE TO LACK OF SYSTEM AND PROCEDURE DETAILS. NO VIDEO OR IMAGES WERE PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IN THE JOURNAL ARTICLE TITLED, ¿A PROSPECTIVE LONGITUDINAL STUDY OF QUALITY OF LIFE IN ROBOTIC-ASSISTED SALVAGE SURGERY FOR OROPHARYNGEAL CANCER,¿ A NUMBER OF POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSISTED SURGICAL PROCEDURES WERE NOTED. THE FOLLOWING COMPLICATIONS WERE REPORTED: ANASTOMOTIC LEAKAGE, INTRAABDOMINAL ABSCESS, WOUND INFECTION, ILEUS, BLEEDING, PULMONARY ISSUES, AND RE-OPERATION FOR ANASTOMOTIC LEAKAGE. THE CAUSES OF THE POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." } ], "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": "" } ] }