{ "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": "2955842-2026-32985", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260721", "manufacturer_address_2": "", "pma_pmn_number": "K250674", "date_of_event": "20260622", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260721", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20260319", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1945957", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260721", "brand_name": "DA VINCI ENERGY", "generic_name": "VESSEL SEALER CURVED", "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": "480522-02", "catalog_number": "480522", "lot_number": "K11260319 0036", "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": [ "Failure to Seal" ], "reporter_state_code": "UT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260727", "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": "20260721", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " D" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bacterial Infection", "Cardiac Arrest", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20260721", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25891278", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260622", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "408159864", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO PRODUCTS WERE RETURNED FOR FAILURE ANALYSIS AS THE INSTRUMENT WAS DISCARDED AT THE HOSPITAL. REVIEW OF THE SYSTEM LOGS FOR THE DURATION OF THE PROCEDURE SHOWS THE SYSTEM FUNCTIONED NORMALLY AND THERE WERE NO INDICATIONS RELATING TO THIS EVENT. LOG REVIEW OF THE 5 SUBSEQUENT PROCEDURES PERFORMED ON THE SYSTEM SHOW THAT IT FUNCTIONED NORMALLY; NO INTRAOPERATIVE EVENTS OR ISSUES WERE FOUND. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: ENDOSCOPE 30 DEGREE, MONOPOLAR CURVED SCISSORS, FENESTRATED BIPOLAR FORCEPS, TIP-UP FENESTRATED GRASPER, VESSEL SEALER CURVED AND SUREFORM 60 STAPLER. A SITE REVIEW FOUND THAT NO COMPLAINTS HAVE BEEN REPORTED FOR ANY OF THE PRODUCTS USED. REVIEW OF THE VESSEL SEALER CURVED INSTRUMENT LOGS FOUND IT WAS INSTALLED ON THE SYSTEM FOUR TIMES. THE E-200 GENERATOR LOGS SHOWED ONE BI-POLAR AND 239 SEAL EVENTS WITH NO INSTRUMENT RELATED ERRORS FOUND IN THE LOGS. AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) REVIEW OF THE EVENT WAS PERFORMED AND CONCLUDED THAT THE PATIENT HAD MANY SEVERE COMORBIDITIES AND HAD A HIGH MORTALITY RISK BEFORE THE PROCEDURE BEGAN. DURING A PLANNED COLORECTAL RESECTION, THERE WAS A PROBLEM WITH A FAILED SEAL OF A VSC THAT WAS ULTIMATELY CONTROLLED BY USING A STAPLER. ALTHOUGH THERE WAS BLEEDING FROM THIS EVENT, THE VESSEL WAS ULTIMATELY CONTROLLED USING A STAPLER AND THE SURGEON DOES NOT BELIEVE THIS EVENT CONTRIBUTED TO THE EVENTUAL OUTCOME. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, NO INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT." }, { "mdr_text_key": "408159865", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNSPECIFIED COLORECTAL PROCEDURE, THE INFERIOR MESENTERIC ARTERY (IMA) WAS SEALED WITH THE VESSEL SEALER CURVED (VSC) INSTRUMENT AND BLEEDING OCCURRED AFTER SEALING AND CUTTING. THE PATIENT LATER EXPIRED ON POSTOPERATIVE DAY 3. THE SURGEON REPORTED THAT WHEN THE JAWS WERE OPENED, BLEEDING WAS IMMEDIATE. THE IMA HAD AN OPEN LUMEN AND SHOWED NO SIGNS OF SEALING. THE VSC CONTINUED TO BE USED TO SEAL THE IMA TWO MORE TIMES ALONG DIFFERENT POINTS DURING THE PROCEDURE; BLEEDING OCCURRED AFTER EACH SEAL. THE VESSEL HAD TO BE RE-SEALED MORE PROXIMALLY TOWARD THE AORTA TO MOBILIZE THE TISSUE TO CREATE AN OSTOMY. THE SEALING TONES WERE REPORTED AS APPROPRIATE AND NO ERROR MESSAGES WERE PRODUCED WHILE SEALING. THE ESTIMATED BLOOD LOSS WAS 300ML. AFTER THE ROBOTIC PORTION WAS COMPLETED AND DURING CLOSURE, THE PATIENT CODED. RESUSCITATION MEASURES WERE SUCCESSFUL, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT EXPIRED THREE DAYS LATER AFTER THE FAMILY DECIDED TO WITHDRAW CARE. THE SURGEON RELATED THE VSC INABILITY TO SUCCESSFULLY SEAL MULTIPLE TIMES THROUGHOUT THE PROCEDURE TO CHALLENGING TISSUE INTEGRITY DUE TO EDEMA. THE PROCEDURE WAS REPORTED TO BE HIGH-RISK DUE TO THE PATIENT¿S COMORBIDITIES INCLUDING RENAL FAILURE WITH DAILY DIALYSIS, NECROTIZING FASCIITIS, SEPSIS AND A HIGH BMI. THE ACTUAL CAUSE OF DEATH WAS NOT PROVIDED BY THE SURGEON; HE STATED THAT THE PATIENT'S MORTALITY RATE WAS 80-90% DUE TO THE NECROTIZING FASCIITIS." } ], "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": "" } ] }