{ "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": "Death", "report_number": "2955842-2024-14687", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240602", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240108", "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", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20240602", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211012", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "629453", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240602", "brand_name": "DA VINCI SP", "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": "380601-45", "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": "00886874114605", "udi_public": "(01)00886874114605", "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": "20250819", "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": "20240602", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " D", " L" ], "patient_age": "70 YR", "patient_sex": "Male", "patient_weight": "45 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Sepsis", "Thrombosis/Thrombus", "Rectal Anastomotic Leakage", "Sepsis", "Thrombosis/Thrombus", "Rectal Anastomotic Leakage" ] } ], "distributor_city": "", "date_report": "20240328", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19444804", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240328", "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": "343854429", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNEVENTFUL DA VINCI ASSISTED LOW ANTERIOR RESECTION FOR COLORECTAL CANCER. THE SURGEON STATED THAT THE ANASTOMOSIS WAS END-TO-END, CREATED WITH AN ETHICON ILS 29 CIRCULAR STAPLER. TESTING OF THE ANASTOMOSIS WAS PERFORMED DURING THE OPERATION AND NO LEAKAGE WAS FOUND. THE PATIENT EXPERIENCED COMPLICATIONS POSTOPERATIVELY AND EXPIRED APPROXIMATELY 69 DAYS POST-PROCEDURE. THERE WAS NO REPORT OF ANY ISSUES WITH THE DAVINCI PRODUCTS. ON POST-OPERATIVE DAY 4 (POD) THE PATIENT'S BLOOD PRESSURE SIGNIFICANTLY DROPPED AND CT SCANS SHOWED PNEUMOPERITONEUM. ANASTOMOSIS LEAKAGE, PERITONITIS, AND SEPSIS WERE SUSPECTED AND AN EMERGENT RE-OPERATION WAS PERFORMED. THE PATIENT REQUIRED POST-OPERATIVE CIRCULATORY AND OXYGEN SUPPORT VIA VENO-ARTERIAL AND VENO-VENO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND VASOPRESSORS DUE TO RESPIRATORY FAILURE AND SEPTIC SHOCK. ON POD 7 THE CIRCULATORY SUPPORT WAS CHANGED TO VENO-VENOUS ECMO ONLY, WHICH WAS REMOVED FIVE DAYS LATER AFTER THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR ILEOSTOMY AND WOUND INFECTIONS. THE PATIENT'S HAND BECAME CYANOTIC FROM THE ECMO TREATMENT REQUIRING ARTERIAL EMBOLECTOMY AND HYPERBARIC OXYGEN THERAPY. APPROXIMATELY TWO MONTHS AFTER THE INITIAL ROBOTIC PROCEDURE, THE PATIENT AND FAMILY MEMBERS REQUESTED TREATMENT BE DISCONTINUED AND THE PATIENT WAS DISCHARGED HOME. THE PATIENT EXPIRED THE FOLLOWING MORNING. THE CAUSE OF DEATH WAS REPORTED AS SEVERE SEPSIS AND COMPLICATIONS FROM ECMO." }, { "mdr_text_key": "343854430", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REVIEW OF THE DA VINCI SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND NO RELATED SYSTEM ERRORS OCCURRED THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE 5 PROCEDURES PERFORMED ON THE SYSTEM SUBSEQUENT TO THE REPORTED EVENT ALSO FOUND NO RELATED ERRORS. A DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THE PATIENT EVENT. THE FOLLOWING CONCOMITANT DEVICES WERE USED DURING THE PROCEDURE: 0 DEGREE ENDOSCOPE, FENESTRATED BIPOLAR FORCEPS, ROUND TOOTH RETRACTOR, MONOPOLAR CURVED SCISSOR, TWO MEDIUM-LARGE CLIP APPLIERS. A SITE REVIEW FOUND THAT NO COMPLAINTS HAVE BEEN REPORTED FOR ANY OF THE PRODUCTS USED. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE MEDICAL SAFETY OFFICER CONCLUDED THAT THE PATIENT UNDERWENT A ROBOTIC ASSISTED LOW ANTERIOR RESECTION FOR COLORECTAL CANCER. THEY DEVELOPED A LEAK AT THE LOCATION OF THE BOWEL ANASTOMOSIS WHICH WAS CREATED WITH A THIRD PARTY END-TO-END ANASTOMOSIS (EEA) STAPLER. THE RESULT OF THIS REQUIRED A REOPERATION WITH WASHOUT AND ILEOSTOMY. THE PATIENT REQUIRED INCREASED SUPPORT WITH ECMO AND A PROLONGED ICU STAY. THE PATIENT EVENTUALLY CAME OFF ECMO AND WENT HOME BUT DIED SOON THEREAFTER. BASED ON THE INFORMATION PROVIDED BY THE SUMMARY OF EVENTS, THE LEAK FROM THE ANASTOMOSIS IN WHICH A THIRD-PARTY STAPLER WAS USED CONTRIBUTED TO THE COMPLICATED POST OPERATIVE COURSE. HOWEVER, THIS STAPLER IS NOT AN INTUITIVE SURGICAL PRODUCT. NO INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT." } ], "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": "" } ] }