{ "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": "2955842-2024-18172", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240814", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20231219", "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", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "", "manufacturer_contact_area_code": "408", "date_added": "20240815", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1177569", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240814", "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": "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": "N/A", "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": "20250820", "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": "20240814", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "3 YR", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumonia", "Vomiting", "Obstruction/Occlusion", "Pneumonia", "Vomiting", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20240717", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19988288", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240717", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "349334743", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MEDWATCH REPORT REFLECTS ADVERSE EVENT-ONLY DATA FROM A LITERATURE ARTICLE. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. ADDITIONALLY, THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATIONS: EVALUATION OF ROBOT-ASSISTED LAPAROSCOPIC VERSUS CONVENTIONAL LAPAROSCOPIC HIATAL HERNIA REPAIR IN CHILDREN. (GAO, Y., HAN, X., AND TAN, Z., 2023) JOURNAL OF ROBOTIC SURGERY (2024) 18:32; HTTPS://DOI.ORG/10.1007/S11701-023-01805-6 BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE PATIENT DEMOGRAPHICS SECTION UTILIZED MEDIAN AGE DUE TO THE UNAVAILABILITY OF SPECIFIC INFORMATION IN THE LITERATURE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD E1 - THE EVENT SITE IS RECORDED BASED ON THE LOCATION OF THE FIRST AUTHOR'S ASSOCIATED HOSPITAL. WHILE THE EXACT SITE IS UNKNOWN, THIS DESIGNATION IS CONSIDERED APPROPRIATE SUBSTITUTION DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED HAS BEEN USED." }, { "mdr_text_key": "349334744", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT ELECTIVE LAPAROSCOPIC OR ROBOT-ASSISTED LAPAROSCOPIC HIATAL HERNIA (HH) REPAIR BETWEEN JANUARY 2020 AND DECEMBER 2022 WAS CONDUCTED TO EVALUATE THE CLINICAL EFFECTS OF ROBOT-ASSISTED LAPAROSCOPIC SURGERY (RALS) AND CONVENTIONAL LAPAROSCOPIC SURGERY (CLS) IN TREATING HH IN CHILDREN. FIFTY-FOUR PATIENTS WERE INITIALLY ENROLLED IN THE STUDY; HOWEVER, NINE PATIENTS WERE EXCLUDED DUE TO FACTORS SUCH AS GASTROESOPHAGEAL REFLUX (GER), SERIOUS DISEASES, AND INCOMPLETE CLINICAL DATA. ULTIMATELY, 46 PATIENTS MET THE INCLUSION CRITERIA, WITH 25 (54.3%) UNDERGOING CLS (GROUP 1) AND 21 UNDERGOING RALS (GROUP 2). THE AVERAGE AGE FOR GROUP 1 WAS 2.2 YEARS, WHILE FOR GROUP 2, IT WAS 3.3 YEARS. THE MEAN FOLLOW-UP PERIOD WAS 18 MONTHS FOR GROUP 1 AND 13 MONTHS FOR GROUP 2. POSTOPERATIVE COMPLICATIONS WERE ASSESSED, WITH PNEUMONIA BEING THE MOST COMMON IN BOTH GROUPS¿OCCURRING IN 5 PATIENTS (20%) IN GROUP 1 AND 2 PATIENTS (9.5%) IN GROUP 2. EACH GROUP HAD ONE PATIENT READMITTED DUE TO REPEATED VOMITING WITHIN ONE MONTH POST-OPERATION, BOTH OF WHOM RECOVERED WITH CONSERVATIVE TREATMENT. ADDITIONAL COMPLICATIONS INCLUDED ONE CASE OF PNEUMOTHORAX IN GROUP 1, ATTRIBUTED TO PLEURAL RUPTURE DURING THE OPERATION, AND ONE CASE OF INCOMPLETE INTESTINAL OBSTRUCTION IN GROUP 2, WHICH WAS MANAGED NON-OPERATIVELY. THE STUDY ACKNOWLEDGES SEVERAL LIMITATIONS: IT WAS A SINGLE-CENTER, RETROSPECTIVE STUDY WITH A SMALL PATIENT SAMPLE SIZE, POTENTIALLY AFFECTING THE GENERALIZABILITY OF THE FINDINGS. THE VARIED FOLLOW-UP TIMES AMONG PATIENTS MIGHT HAVE INFLUENCED THE REPORTING OF POSTOPERATIVE COMPLICATIONS. ADDITIONALLY, PATIENTS WERE NOT CATEGORIZED BASED ON ELECTIVE OR URGENT STATUS AT ADMISSION, WHICH COULD BE BENEFICIAL FOR EVALUATING THE SURGICAL PROCEDURES' EFFECTIVENESS FURTHER. INITIAL RESULTS INDICATE THAT THE ROBOTIC TECHNIQUE IS EFFECTIVE AND SAFE FOR MANAGING HH IN CHILDREN, SHOWCASING ADVANTAGES IN POSTOPERATIVE HOSPITAL LENGTH OF STAY (LOS), INTRAOPERATIVE BLEEDING, POSTOPERATIVE FASTING TIME, AND ICU ADMISSION. AS THE FIRST REPORT TO COMPARE RALS AND CLS IN THIS CONTEXT, THE STUDY SUGGESTS THAT FURTHER RESEARCH, INCLUDING LARGER SAMPLE SIZES AND PROSPECTIVE LONG-TERM ASSESSMENTS, IS NECESSARY TO VALIDATE THESE FINDINGS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE." } ], "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": "" } ] }