{ "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": "2955842-2022-11705", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220520", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20220418", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220520", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2450807", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220520", "brand_name": "DA VINCI", "generic_name": "UNKNOWN 8MM OBTURATOR", "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": "R", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "health_professional": "", "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": "20220520", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "29 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20220419", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14454859", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220419", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "292156491", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED THE CAUSE OF THE REPORTED INJURY THAT LED TO THE PATIENT'S DEMISE IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. . THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: BASED UPON THE INFORMATION IN THE DESCRIPTION OF EVENTS, THE PATIENT SUSTAINED AN INJURY DURING THE PLACEMENT OF THE INITIAL ISI TROCAR USING A DIRECT VISUALIZATION TECHNIQUE. IT IS UNCLEAR AS TO THE CAUSE OF THE INJURY WHICH ULTIMATELY LED TO THE PATIENT¿S DEATH. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. NO SYSTEM LOGS ARE AVAILABLE FOR REVIEW AS THE SYSTEM WAS NEVER USED. THE EVENT OCCURRED PRIOR TO THE START OF A PLANNED DA VINCI-ASSISTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: PRIOR TO THE START OF A PLANNED DA VINCI-ASSISTED SURGICAL PROCEDURE AND WHILE ATTEMPTING TO GAIN INITIAL ACCESS TO THE ABDOMINAL CAVITY, THE SURGEON INSERTED AN ISI 8MM TROCAR AND OBTURATOR IN THE LEFT UPPER QUADRANT UNDER DIRECT VISUALIZATION AND INJURED A VESSEL. THE INJURY TO THE VESSEL ULTIMATELY RESULTED IN THE PATIENT¿S DEMISE. ALTHOUGH THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, THE CAUSE OF THE VESSEL INJURY RESULTING WITH THE PATIENT'S DEMISE IS UNKNOWN." }, { "mdr_text_key": "292156492", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING INITIAL ENTRY WITH AN INTUITIVE SURGICAL, INC. (ISI) TROCAR AND OBTURATOR AT THE START OF A VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE TO IDENTIFY THE SOURCE OF THE BLEEDING. THREE OTHER SURGEONS WERE ASKED TO ASSIST WITH FINDING THE SOURCE OF THE BLEEDING. HOWEVER, THE SURGEONS COULD NOT IDENTIFY THE INJURED VESSEL, AND THE PATIENT REPORTEDLY EXPIRED. ISI CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IN AN ATTEMPT TO GAIN INITIAL ACCESS TO THE ABDOMINAL CAVITY, THE SURGEON INSERTED AN ISI 8MM TROCAR IN THE LEFT UPPER QUADRANT UNDER DIRECT VISUALIZATION. THE ABDOMINAL CAVITY WAS NOT SUCCESSFULLY ENTERED DURING THE FIRST ATTEMPT AS THE SURGEON ONLY SAW FAT. DURING THE SECOND ATTEMPT, THE SURGEON AGAIN FAILED TO GAIN ACCESS. HOWEVER, AFTER THE SECOND ATTEMPT TO GAIN ACCESS, BLOOD WAS SEEN ALONG WITH FAT. THE SURGEON WAS NOT SURE IF THERE WAS ANY MISIDENTIFICATION OF ANATOMY DUE TO THE AMOUNT OF FAT. THE ANESTHESIOLOGIST STATED THAT THE BLOOD PRESSURE WAS INITIALLY STABLE. THE SURGEON THEN CONVERTED TO AN OPEN SURGICAL PROCEDURE TO IDENTIFY THE SOURCE OF THE BLEEDING. SHE COULD NOT IDENTIFY THE SOURCE OF THE BLEEDING AND HENCE CALLED IN A FEW COLLEAGUES WITH 15 YEARS OF EXPERIENCE TO ASSIST IN DETERMINING THE SOURCE. AS THEY WERE EXPLORING, THERE WAS ¿NOTHING EXPANDING,¿ AND THE PATIENT ABDOMEN WAS NOT FILLING. SHE BELIEVES SHE COULD HAVE SKIVED THE DEPTH OF THE FAT TISSUE AND ENTERED THE RETROPERITONEUM. THE SURGEONS IDENTIFIED A SMALL ENTRY SITE, AND THEY SAW EITHER THE GONADAL OR THE LUMBAR VESSEL BLEED AND CONTROLLED THE BLEED. THERE WAS A HEMATOMA, AND THE PATIENT WAS EXPERIENCING ¿EXSANGUINATION.¿ THE SURGEON WAS NOT SURE IF THE IVC WAS INJURED. SINCE THE ABDOMEN WAS NOT FILLING, SHE WAS NOT SURE IF THERE WAS A COMBINATION OF BLEEDING AND EMBOLI. THE PATIENT BECAME UNSTABLE AND SHE RECEIVED MULTIPLE CHEST COMPRESSIONS. HOWEVER, THE PATIENT ULTIMATELY EXPIRED ON THE TABLE. THERE IS NO VIDEO RECORDING OF THE PROCEDURE. THE DA VINCI SYSTEM WAS NOT DOCKED. SHE IS NOT SURE IF THE ISI TROCAR AND OBTURATOR WILL BE RETURNED TO ISI. AS PER THE SURGEON, THE CAUSE OF DEATH IS A HEMORRHAGIC SHOCK. HOWEVER, THERE IS AN AUTOPSY BEING PERFORMED FOR THE FINAL REPORT. AS OF THE DATE OF THIS REPORT, THE AUTOPSY REPORT IS UNAVAILABLE. ALTHOUGH AN ISI TROCAR WAS INVOLVED WITH THE VESSEL INJURY, THE SURGEON CONFIRMED NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON A FOLLOW-UP WITH THE ISI EXECUTIVE SALES REPRESENTATIVE (ESR), SHE STATED THAT THIS SURGEON WAS NEW TO ROBOTICS AND SURGERIES IN GENERAL, AS SHE WAS OUT OF RESIDENCY SUMMER OF LAST YEAR (2021)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }