{ "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": "+1(408)5", "event_type": "Injury", "report_number": "2955842-2026-35102", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260812", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250812", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "+1(408)523-2100", "noe_summarized": "1", "manufacturer_contact_l_name": "Nielson", "source_type": [ "Other", "Study", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260813", "manufacturer_contact_f_name": "Izabel", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "638907", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260812", "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", "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" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260812", "sequence_number_treatment": [ "da Vinci Instruments and Accessories." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Pleural Effusion", "Atelectasis" ] } ], "distributor_city": "", "date_report": "20260722", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Santa Clara", "mdr_report_key": "50222679", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260722", "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": "15976541678", "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. No image(s) and/or video clip(s) associated with this reported event were reviewed.Citation: Delgado-Miguel, C., & Camps, J. I. (2025). Robotic surgery in newborns and infants under 12-months: Is it feasible? Asian Journal of Surgery, 48, 6032 - 6036. https://doi.org/10.1016/j.asjsur.2025.03.364The missing patient information in sections A and B was either unknown, unavailable, not provided, or not applicable. The article provided ranges for certain demographic information: Gender: 51 males; 49 females; Median age: 5 months at surgery (interquartile range: 3¿8 months); and Median weight of 6.2 kg (IQR 5.4¿8.3 kg)." }, { "mdr_text_key": "15476541677", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A clinical study article reported a retrospective single-center study of consecutive children under 12 months of age who underwent robotic surgery between 2010 and 2020. All procedures were performed using the da Vinci Si surgical system.Postoperative complications were reported in 6 patients, 2 of whom required reoperation. These complications included partial dehiscence of an anorectal anastomosis due to surgical wound infection requiring redo surgery, ileus, accidental gastrostomy outlet requiring endoscopic placement, pleural effusion, bradycardia, and atelectasis.The authors concluded that robotic surgery in newborns and infants can be considered feasible and safe when performed by well-trained surgeons. They also suggested that a wide range of procedures, including complex surgeries in small children, can be carried out safely with a very low complication rate. It was recommended that, further multicenter studies are needed to validate these findings.Intuitive Surgical Inc. (ISI) has made multiple attempts to obtain additional information; however, as of the date of this report, no new information has been obtained." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 Central Expressway", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }