{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2021-11231", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20211001", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "LITERATURE", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "IT", "manufacturer_contact_area_code": "", "date_added": "20211001", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1460934", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211001", "brand_name": "DA VINCI", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "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": "", "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": "", "date_changed": "20250729", "health_professional": "", "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": "20211001", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20210902", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12564740", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210902", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "275151393", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO INITIAL REPORT OR ALLEGATION FROM THE JOURNAL ARTICLE AUTHOR, OR ANY KNOWN ALLEGATION FROM A MEDICAL PROFESSIONAL, OF A SPECIFIC DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SYSTEM AND INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO LACK OF SITE, SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE, IT IS NOTED THAT SEVERE POST-OPERATIVE COMPLICATIONS OCCURRED IN RELATION TO ROBOTIC-ASSISTED TOTAL PANCREATECTOMY PROCEDURES. ALTHOUGH THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, THE CAUSE OF THE SEVERE POST-OPERATIVE COMPLICATIONS IS UNKNOWN. DETAILS REGARDING THE COMPLICATIONS WERE NOT PROVIDED. ADDITIONALLY, IT IS UNKNOWN IF THERE WERE ANY INTRA-OPERATIVE COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURES OR ANY MEDICAL INTERVENTION RENDERED DUE TO THE POST-OPERATIVE COMPLICATIONS. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. DUE TO LACK OF PRODUCT INFORMATION, (510K NO.), AND (MFG DATE) ARE NOT AVAILABLE. THE PRODUCT IS NOT IMPLANTABLE." }, { "mdr_text_key": "275151394", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 02-SEP-2021, INTUITIVE SURGICAL (ISI) BECAME AWARE OF AN UPDATES IN SURGERY ARTICLE TITLED, ¿FEASIBILITY AND SAFETY OF ROBOTIC-ASSISTED TOTAL PANCREATECTOMY (RATP): THIS STUDY INCLUDES PATIENTS OPERATED BETWEEN OCTOBER 2008 AND DECEMBER 2019: A PILOT WESTERN SERIES¿ (KAUFFMANN, E. F., NAPOLI, N., ET AL., 2021). WITHIN THE ARTICLE, THE FOLLOWING WAS NOTED: \"REGARDING THE MAIN ENDPOINT OF THIS STUDY, AS SHOWN IN TABLE 3, SEVERE POST-OPERATIVE COMPLICATIONS DEVELOPED IN 6 PATIENTS (24.0%) AFTER RATP AND IN 13 PATIENTS (26.0%) AFTER OTP (P=0.85).\" ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }