{ "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": "2955842-2020-10219", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200324", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200324", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "334176", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200324", "brand_name": "DA VINCI", "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": "380430-01", "catalog_number": "", "lot_number": "", "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", "Insufficient Device Problem Information", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20200324", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20200226", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9876146", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200226", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "196440825", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. AT THIS TIME, THE FOLLOWING INFORMATION IS UNKNOWN: THE DATE OF THE DA VINCI-ASSISTED SURGICAL PROCEDURE, DETAILS REGARDING THE \"ULTRACISION\" DEVICE, IF THERE WAS AN ALLEGED DEVICE MALFUNCTION, IF THERE WERE ANY INTRA-OPERATIVE COMPLICATIONS, THE OUTCOME OF THE SURGICAL PROCEDURE, AND THE PATIENT'S CURRENT STATUS. ISI HAS ATTEMPTED TO CONTACT THE AUTHOR CORRESPONDENCE OF THE CLINICAL ARTICLE AND THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM LOGS FOR THE REPORTED EVENT CANNOT BE PERFORMED SINCE THE EVENT DATE IS UNKNOWN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED \"SPLEEN-PRESERVING DISTAL PANCREATIC RESECTION\" PROCEDURE, THE PATIENT \"HAD TO UNDERGO RESUSCITATION AND AN EMERGENCY LAPAROTOMY TO CONTROL A BLEEDING FROM THE SPLENIC ARTERY.\" PER THE JOURNAL ARTICLE, IT WAS ALLEGED THAT \"THE BLEEDING WAS MOST LIKELY CAUSED BY NECROSIS OF THE VESSEL WALL RESULTING FROM THE ULTRACISION DEVICE.\" HOWEVER, AT THIS TIME, DETAILS REGARDING THE \"ULTRACISION\" DEVICE ARE UNKNOWN." }, { "mdr_text_key": "196440826", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A WORLD JOURNAL OF SURGERY ARTICLE TITLED, ¿MINIMALLY INVASIVE VERSUS OPEN PANCREATIC SURGERY IN PATIENTS WITH MULTIPLE ENDOCRINE NEOPLASIA TYPE 1¿ ( C. LOPEZ, ET AL. 2016). PER THE CLINICAL ARTICLE, EIGHT HOURS AFTER UNDERGOING A DA VINCI-ASSISTED SPLEEN-PRESERVING DISTAL PANCREATIC RESECTION PROCEDURE, THE PATIENT EXPERIENCED \"LIFE-THREATENING\" POST-OPERATIVE BLOOD LOSS. THE PATIENT UNDERWENT RESUSCITATION AND AN EMERGENCY LAPAROTOMY TO CONTROL BLEEDING FROM THE SPLENIC ARTERY. THE BLEEDING WAS \"MOST LIKELY CAUSED BY A NECROSIS OF THE VESSEL WALL RESULTING FROM THE ULTRACISION DEVICE.\"" } ], "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": "" } ] }