{ "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": "2955842-2025-44877", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251120", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20250220", "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", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "IN", "manufacturer_contact_area_code": "408", "date_added": "20251120", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20140630", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "159919", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251120", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "PATIENT SIDE CART, 4-ARM", "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": "380652-22", "catalog_number": "N/A", "lot_number": "UNKNOWN", "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": "20251215", "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": "20251120", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Unspecified Infection", "Obstruction/Occlusion", "Wound Dehiscence", "Unspecified Infection", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20251120", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23605529", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251021", "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": "385683501", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE TITLED, ¿LAPAROSCOPIC VERSUS ROBOTIC LATERAL PELVIC LYMPH NODE DISSECTION IN LOCALLY-ADVANCED RECTAL CANCER: A COHORT STUDY COMPARING PERIOPERATIVE MORBIDITY AND SHORT-TERM ONCOLOGICAL OUTCOMES,¿ WAS PERFORMED. THE GOAL OF THE STUDY NOTED IN THE ARTICLE WAS TO EVALUATE THE OUTCOMES OF ROBOTIC AND LAPAROSCOPIC LATERAL PELVIC LYMPH NODE DISSECTION (LPLND) IN PATIENTS WITH LATERAL PELVIC NODE-POSITIVE LOCALLY ADVANCED RECTAL CANCER (LARC) WITH REFERENCE TO INTRAOPERATIVE SAFETY, POSTOPERATIVE MORBIDITY, PATHOLOGICAL INDICES INCLUDING NODAL YIELD AND NODE POSITIVITY RATES, LATERAL PELVIC RECURRENCE RATES, AND SHORT-TERM EVENT-FREE AND OVERALL SURVIVAL. THIS WAS A RETROSPECTIVE SINGLE-CENTER STUDY THAT EVALUATED 115 PATIENTS BETWEEN 2014 AND 2023. THE ARTICLE NOTED THAT THAT DURING THESE DA VINCI-ASSISTED SURGERIES, IN THE IMMEDIATE POSTOPERATIVE PERIOD, FOUR PATIENTS (TWO FROM EACH GROUP) REQUIRED RE-EXPLORATION FOR ISSUES INCLUDING DISTAL MARGIN POSITIVITY, FASCIAL DEHISCENCE WITH EVISCERATION, AND ACUTE INTESTINAL OBSTRUCTION DUE TO EMPTY-PELVIS SYNDROME OR PORT-SITE HERNIA. THESE OCCURRED AT A MEDIAN OF 10 DAYS POST-SURGERY (RANGE: 6¿21 DAYS). CLINICALLY SIGNIFICANT MORBIDITY (CLAVIEN¿DINDO GRADE III OR HIGHER) WAS OBSERVED IN 13.9% OF PATIENTS. PELVIC COLLECTIONS REQUIRING DRAINAGE WERE THE MOST COMMON COMPLICATION, WITH 18.2% COMPLICATED BY SUPER ADDED INFECTION OR ANATOMICAL IMPINGEMENT. SURGICAL SITE OCCURRENCES INCLUDING SEROMAS, SUPERFICIAL INFECTIONS, AND WOUND DEHISCENCE WERE EXCLUSIVELY NOTED WITHIN THE FIRST POSTOPERATIVE MONTH. PER THE AUTHOR, NONE OF THE ADVERSE EVENTS WERE RELATED TO A DA VINCI DEVICE. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED." }, { "mdr_text_key": "385683502", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. IN SECTION B3, THERE IS INSUFFICIENT INFORMATION REGARDING THE PROCEDURE DATE; THEREFORE, THE ARTICLE PUBLISH DATE WAS USED. SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE WAS 21-OCT-2025. IN SECTION D4, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, A GENERIC XI SYSTEM WAS REPORTED. CITATION: MATHEW, J., ET AL. (2025B). LAPAROSCOPIC VERSUS ROBOTIC LATERAL PELVIC LYMPH NODE DISSECTION IN LOCALLY-ADVANCED RECTAL CANCER: A COHORT STUDY COMPARING PERIOPERATIVE MORBIDITY AND SHORT-TERM ONCOLOGICAL OUTCOMES. CANCER REPORTS, 8(3). HTTPS://DOI.ORG/10.1002/CNR2.70174." } ], "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": "" } ] }