{ "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": "2955842-2026-17727", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260330", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250415", "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": "CH", "manufacturer_contact_area_code": "", "date_added": "20260330", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "773079", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260330", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI SURGICAL SYSTEM", "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": "N/A", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260612", "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": "20260330", "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": [ "Obstruction/Occlusion", "Ascites", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260302", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24712512", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260302", "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": "397017986", "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. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. 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 02-MAR-2026. 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: CHEN, K., ZHANG, S., CHEN, Q., & GAO, Z. (2025). COMPARING ROBOT-ASSISTED VERSUS LAPAROSCOPIC LADD¿S PROCEDURE IN CHILDREN WITH CONGENITAL INTESTINAL MALROTATION. UPDATES IN SURGERY, 78(1), 161¿167. HTTPS://DOI.ORG/10.1007/S13304-025-02177-2." }, { "mdr_text_key": "396838289", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A CLINICAL ARTICLE WAS REVIEWED AND THE GOAL OF THE STUDY WAS TO PERFORM A COMPARATIVE ANALYSIS OF ROBOT-ASSISTED VERSUS LAPAROSCOPIC LADD'S PROCEDURE ON PERI AND POSTOPERATIVE OUTCOMES. THE STUDY EVALUATED 95 PEDIATRIC PATIENTS, OF WHOM 57 UNDERWENT ROBOT ASSISTED SURGERY USING THE DA VINCI XI SYSTEM AND 38 UNDERWENT LAPAROSCOPIC SURGERY. ALL LADD¿S PROCEDURES PERFORMED ON PATIENTS AGED UP TO 18 YEARS OLD BETWEEN JANUARY 2020 AND DECEMBER 2023. POSTOPERATIVE COMPLICATIONS OCCURRED IN BOTH GROUPS, WITH A LOWER OVERALL COMPLICATION RATE IN THE ROBOTIC COHORT (3.5%) COMPARED TO THE LAPAROSCOPIC COHORT (18.4%). WITHIN THE ROBOT ASSISTED GROUP, TWO POSTOPERATIVE COMPLICATIONS WERE REPORTED: CHYLOUS ASCITES AND ADHESIVE BOWEL OBSTRUCTION, WITH ONE PATIENT REQUIRING SECONDARY SURGERY DUE TO THE OBSTRUCTION. THE ARTICLE DID NOT REPORT ANY INTRAOPERATIVE DEVICE MALFUNCTIONS OR SYSTEM ERRORS RELATED TO THE DA VINCI SYSTEM. ALL ROBOTIC PROCEDURES WERE COMPLETED WITHOUT CONVERSION TO OPEN SURGERY. THE SURGERY CASE IN THE ROBOTIC GROUP WAS ASSOCIATED WITH POSTOPERATIVE ADHESIVE OBSTRUCTION. THE ARTICLE NOTES THAT THE CAUSE MAY BE RELATED TO LACK OF TACTILE FEEDBACK IN ROBOTIC SURGERY, WHICH LED TO THE INJURY OF THE INTESTINAL SEROMUSCULAR LAYER DURING THE PROCESS OF GRASPING AND PULLING THE INTESTINE BY THE SURGEON. 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": "" } ] }