{ "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": "2955842-2024-18112", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240815", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240110", "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": "US", "manufacturer_contact_area_code": "408", "date_added": "20240815", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1163358", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240815", "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": "20240815", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "57 YR", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Skin Infection", "Abscess", "Skin Infection" ] } ], "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": "19990259", "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": "349349595", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MDR 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. THE DESIGNATE AUTHOR WAS CONTACTED FOR ADDITIONAL INFORMATION UNSUCCESSFULLY. CITATION: CORZO, M. P., TOMEY, D., MARTININO, A., SECCHI, R., ELZEIN, S., LEE, Y. K., ABOU-MRAD, A., & OVIEDO, R. J. (2024). FEASIBILITY OF ROBOTIC CHOLECYSTECTOMY AT AN ACADEMIC CENTER WITH A YOUNG ROBOTIC SURGERY PROGRAM: A RETROSPECTIVE COHORT STUDY WITH UMBRELLA REVIEW. JOURNAL OF ROBOTIC SURGERY. HTTPS://DOI.ORG/10.1007/S11701-024-01824-X" }, { "mdr_text_key": "349349596", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REVIEW OF THIS LITERATURE ARTICLE THAT DESCRIBED A RETROSPECTIVE ANALYSIS AND AN UMBRELLA SYSTEMATIC REVIEW WAS PERFORMED. THE AIM OF THE STUDY WAS TO EXPLORE THE DIFFERENCES IN CLINICAL OUTCOMES OF PATIENTS UNDERGOING MINIMALLY INVASIVE CHOLECYSTECTOMY USING LAPAROSCOPIC AND ROBOTIC APPROACHES AT A SINGLE ACADEMIC CENTER WITH A NEWLY ESTABLISHED ROBOTIC SURGERY PROGRAM. THE CONCLUSION OF THE STUDY FOUND THAT ROBOTIC CHOLECYSTECTOMY IS FEASIBLE AND SAFE IN AN ACADEMIC SETTING, WITH CLINICAL OUTCOMES COMPARABLE TO LAPAROSCOPIC CHOLECYSTECTOMY. THE STUDY OCCURRED FROM NOVEMBER 2020 AND JANUARY 2022. THE ARTICLE NOTED THAT THE STUDY EXAMINED CHOLECYSTECTOMY PROCEDURES PERFORMED BY A SINGLE SURGEON, INCLUDING 61 LAPAROSCOPIC CHOLECYSTECTOMIES (LC) AND 42 ROBOTIC CHOLECYSTECTOMIES (RC), WITH RC PATIENTS BEING OLDER AND HAVING A LOWER BMI COMPARED TO LC PATIENTS. COMPLICATIONS INCLUDED INTRA-ABDOMINAL ABSCESSES (3 CASES) AND A SURGICAL SITE INFECTION (1 CASE), WITH NO CONVERSIONS TO OPEN PROCEDURES, BILE LEAKS, SMALL BOWEL OBSTRUCTIONS, OR BLOOD TRANSFUSIONS NEEDED. THE ARTICLE DOCUMENTED THAT THERE WERE SEVERAL LIMITATIONS TO THIS STUDY. THESE INCLUDE ITS SINGLE-SURGEON SCOPE, MAKING IT DIFFICULT TO GENERALIZE THE RESULTS TO A BROADER SURGEON EXPERIENCE. THE RETROSPECTIVE NATURE OF THE STUDY AND POTENTIAL SELECTION BIAS FURTHER LIMIT ITS APPLICABILITY. ADDITIONALLY, THE UMBRELLA SYSTEMATIC REVIEW INCLUDED IN THE STUDY FACED CHALLENGES DUE TO HIGH HETEROGENEITY BETWEEN THE ANALYZED STUDIES AND A LACK OF COHESION AMONG REPORTING VARIABLES, WHICH DIMINISHES THE POWER OF THE REVIEW. FUTURE STUDIES SHOULD INCLUDE PROSPECTIVE, BLINDED, RANDOMIZED CONTROLLED TRIALS WITH COST ANALYSIS FOR BOTH ELECTIVE AND EMERGENT INDICATIONS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. COMMUNICATION WITH THE DESIGNATED AUTHOR WAS PERFORMED WHO CONFIRMED THAT THE COMPLICATION RATES WERE WITHIN THE EXPECTED RANGE. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }