{ "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": "2955842-2026-22579", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260423", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20220917", "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": "UK", "manufacturer_contact_area_code": "", "date_added": "20260423", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1033278", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260423", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "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": "20260423", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "67 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260327", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24971897", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260327", "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": "399361225", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF AN ARTICLE WAS PERFORMED THAT EVALUATED THE CASE OF A PATIENT THAT SUSTAINED AN AORTIC INJURY DURING A DA VINCI-ASSISTED RETROPERITONEAL LYMPHADENECTOMY PROCEDURE. THE CAUSE OF THE AORTIC INJURY IS UNKNOWN. REPAIR OF THE COMPLICATION COULD NOT BE PERFORMED LAPAROSCOPICALLY; HOWEVER, GRASPER INSTRUMENTS WERE USED TO MAINTAIN HEMOSTASIS WHILE A CONVERSION TO OPEN SURGERY WAS INITIATED. SAFETY MECHANISMS LOCKED THE GRASPERS IN PLACE, PREVENTING TISSUE RELEASE, BUT RESULTING IN ADDITIONAL AORTIC INJURY. FORCEFUL REMOVAL OF THE GRASPERS WAS EVENTUALLY SUCCESSFUL, AND DEFINITIVE AORTIC REPAIR WAS THEN PERFORMED. THE PATIENT REPORTEDLY DID WELL POST-OPERATIVELY AND WAS DISCHARGED HOME. THE ARTICLE NOTES: \"PATHOLOGIC EXAMINATION REVEALED A MALIGNANT MIXED MÜLLERIAN TUMOR OF THE ENDOMETRIUM WITH LYMPH NODE METASTASIS. ONE YEAR LATER, SHE HAD COMPLETED CHEMOTHERAPY, WAS LIVING INDEPENDENTLY, AND WAS IN REMISSION. SHE HAD NO ABDOMINAL COMPLAINTS OR CLAUDICATION. SURVEILLANCE AXIAL IMAGING DID DEMONSTRATE A 35% REDUCTION IN VESSEL DIAMETER AT THE SITE OF REPAIR.\" MULTIPLE ATTEMPTS TO CONTACT AUTHOR AND REPORTER WERE MADE, NO RESPONSE WITH ADDITIONAL INFORMATION." }, { "mdr_text_key": "399361226", "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. IMAGES ASSOCIATED WITH THIS REPORTED EVENT WERE INCLUDED IN THE ARTICLE. ONE IMAGE SHOWS THE INFRARENAL AORTA WITH AN INJURY NEAR THE INFERIOR MESENTERIC ARTERY ORIGIN. THE SECOND IMAGE SHOW THE INFRARENAL AORTA AFTER REPAIR WITH BOVINE PERICARDIUM PATCH. CITATION: LAU, P. J., MCGREEVY, J. M., THOMES PEPIN, J. A., RAMASWAMY, A., & FAIZER, R. (2023). CHALLENGES OF CONVERSION FROM ROBOTIC SURGERY FOR VASCULAR COMPLICATIONS. JOURNAL OF VASCULAR SURGERY CASES, INNOVATIONS AND TECHNIQUES, 9, 1¿4. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2022.09.010." } ], "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": "" } ] }