{ "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": "HOSPITAL", "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": "Death", "report_number": "2955842-2013-01557", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130507", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130409", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130507", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "198101", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130507", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS3000 A60.P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20130507", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "113", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20130409", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3096412", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130409", "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": "10848809", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) WAS ABLE TO OBTAIN THE OPERATIVE REPORT CONCERNING THE REPORTED EVENT. BASED ON THE OPERATIVE REPORT AND IN REFERENCE TO A TUMOR, THE SURGEON NOTED, IT ALSO BECAME APPARENT TO ME THAT SINCE IT INVADED THE PHRENIC NERVE THAT IN ORDER TO TRY TO RESECT THIS FOR CURATIVE INTENT THAT THE PATIENT WOULD BE BEST SERVED WITH AN OPEN PROCEDURE AND I MADE A DECISION TO CONVERT FROM THE DA VINCI ROBOTIC PROCEDURE TO A POSTEROLATERAL THORACOTOMY, SO THAT I COULD PLACE MY HAND INSIDE THE CHEST AND DIRECTLY VISUALLY AND MANUALLY INSPECT AND OBSERVE THE EXTENT OF TUMOR INVASION. IT WAS ALSO APPARENT THAT THE MEDICAL ASPECT OF THE LEFT UPPER LOBE WAS QUITE FRIABLE AND I FELT THAT BEING ABLE TO PLACE MY HAND DIRECTLY ON THE LOBE AND RETRACT POSTOPERATIVELY, SO I COULD INSPECT THE ANTEROMEDIAL MEDIASTINUM ESPECIALLY IN THE REGION OF THE HILUM THAT THIS WOULD BE A FAVORABLE APPROACH. IN ADDITION, AS I DISSECTED AROUND THE HILUM AND EXPOSED THE PULMONARY VEIN DRAINING THE UPPER LOBE IT BECAME APPARENT THAT THE TUMOR OR AT LEAST THE VERY DENSE INFLAMMATORY REACTION OF THE TUMOR THAT WOULD HAVE TO BE RESECTED WITH THE WEDGE RESECTION WAS TOO CLOSE TO THE PULMONARY VEIN TO ALLOW WEDGE RESECTION BECAUSE APPLYING THE STAPLER ACROSS THE LUNG AT THIS REGION WOULD MOST LIKELY INTERFERE OR INVOLVE THE PULMONARY VEIN. THEREFORE, THE DECISION BASED ON ALL OF THESE FACTORS WAS MADE TO CONVERT TO THORACOTOMY. ALL OF THE ROBOTIC INSTRUMENTS WERE REMOVED AND THE DA VINCI ROBOT WAS MOVED AWAY FROM THE PATIENT TABLE IN PREPARATION FOR CONVERSION TO THORACOTOMY. THE PATIENT WAS COMPLETELY STABLE AT THIS POINT AND I WENT OUT TO THE WAITING ROOM TO ADVISE THE FAMILY ON THE FACT THAT I WAS GOING TO CONVERT TO THORACOTOMY AND WOULD PROCEED WITH UPPER LOBECTOMY AND THIS MIGHT TAKE SEVERAL MORE HOURS BASED ON THE OPERATIVE FINDINGS INCLUDING THE INVASION INTO THE MEDIASTINUM. DURING THE OPEN THORACOTOMY PROCEDURE AND IN REFERENCE TO THE PATIENT'S PULMONARY ARTERY, THE SURGEON NOTED ON THE OPERATIVE REPORT: THERE WAS STILL A SIGNIFICANT AMOUNT OF INFLAMMATORY REACTION AND SOME LYMPH NODE TISSUE AROUND THIS TRUNK, AND AS I DISSECTED THIS IN PREPARATION FOR COMPLETING THE LOBECTOMY I ENCOUNTERED BLEEDING FROM THE PULMONARY ARTERY AT THE LEVEL OF THE TRUNK AND IMMEDIATELY GAINED CONTROL BY PLACING A SOFT SPONGE STICK OVER THE SITE. THE SURGEON REPORTEDLY REPAIRED THE POINT OF BLEEDING OF THE PULMONARY ARTERY USING A 4-0 PROLENE SUTURE. THE SURGEON NOTED, AFTER REPAIRING THE ARTERY, I REMOVED THE RIGHT-ANGLE CLAMP THAT I HAD PLACED TEMPORARILY TO CONTROL THE BLEEDING AND AS I REMOVED THE CLAMP THERE WAS MORE BLEEDING DIRECTLY FROM THE PULMONARY ARTERY WHERE THIS BRANCH BIFURCATED, AND AGAIN GAINED CONTROL BY DIRECT PRESSURE. IN ADDITION, THE SURGEON INDICATED, I THEN INSPECTED THE AREA OF THE PULMONARY ARTERY WHERE THE TEAR WAS LOCATED AND AGAIN USED 4-0 PROLENE SUTURES AVOIDING ANY TENSION TO REPAIR THE PULMONARY ARTERY AT THE SITE WHERE THE MAIN TRUNK BRANCH TO THE UPPER LOBE WHICH HAD BEEN PREVIOUSLY DIVIDED. THIS INITIALLY PROVIDED A GOOD CONTROL AND THE PROLENE SUTURE WAS TIED SNUGLY AND APPEARED TO BE HEMOSTATIC BUT AFTER I REMOVED THE CLAMP FROM THE PROXIMAL ARTERY THIS TIME I ENCOUNTERED VERY EXTENSIVE BLEEDING DIRECTLY FROM THE PULMONARY ARTERY. ALSO, THE SURGEON INDICATED ON THE OPERATIVE REPORT, AS MY ASSISTANT HELD PRESSURE OVER THE PULMONARY ARTERY AND WE HAD GOOD HEMOSTATIS I WAS ABLE TO ENTER THE PERICARDIUM AND EASILY VISUALIZE THE MAIN PULMONARY ARTERY INTRAPERICARDIALLY. I HAD ANOTHER LONG VASCULAR CLAMP AND I WAS ABLE TO PLACE THIS ACROSS THE PROXIMAL PULMONARY ARTERY IN THE PERICARDIUM UNDER DIRECT VISION ATTEMPTING TO DO THIS VERY CAUTIOUSLY. UNFORTUNATELY I ENCOUNTERED MORE BLEEDING AS I WAS PLACING THIS CLAMP ON THE PULMONARY ARTERY TRUNK AND THIS NOW HAS BECOME A CATASTROPHIC PULMONARY ARTERY TEAR AND AGAIN TRY TO GAIN CONTROL BY GENTLY PLACING THE CLAMP MORE PROXIMALLY WITHOUT SUCCESS AND IT APPEARED THAT EVERY SMALL MANEUVER I MADE IN ORDER TO TRY TO GAIN CONTROL OR REPAIR OF THE ARTERY LEAD TO FURTHER BLEEDING. AT THIS POINT, THERE WAS MASSIVE BLEEDING FROM THE PULMONARY ARTERY SUCH THAT THE PATIENT DEVELOPED PROFOUND HYPERTENSION AND ULTIMATELY LOST BLOOD PRESSURE. I OPENED UP THE PERICARDIUM WIDELY AND PLACED A CLAMP AS PROXIMALLY AS I COULD ON THE LEFT PULMONARY ARTERY AND ALL EFFORTS WERE MADE TO VOLUME RESUSCITATE THE PATENT. I HAD 4 UNITS OF PACKED RED BLOOD CELLS IN THE ROOM WHILE WE HAD CONTROL PRIOR TO THIS CATASTROPHIC EVENT IN PREPARATION OF VERY LARGE SERIOUS BLEEDING BUT YET THIS HAPPENED VERY QUICKLY AND WE WERE NOT ABLE TO RESUSCITATE THE PATIENT. BASED ON THE INFORMATION PROVIDED IN THE OPERATIVE REPORT, THERE IS NO EVIDENCE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE REPORTED EVENT. IN ADDITION, THERE IS NO EVIDENCE THAT THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY TO THE PULMONARY ARTERY AND SUBSEQUENT DEMISE." }, { "mdr_text_key": "19731170", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI PULMONARY WEDGE RESECTION PROCEDURE PERFORMED ON (B)(6) 2013, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. AT THE TIME OF THE CONVERSION, THE DA VINCI SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT AND THE PATIENT WAS REPORTEDLY IN STABLE CONDITION AND WAS DOING FINE. AT AN UNSPECIFIED TIME DURING THE OPEN SURGICAL PROCEDURE, THE PATIENT SUBSEQUENTLY EXPIRED. NO ADDITIONAL CLINICAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "19835896", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS EVENT. THE CSR INDICATED THAT HE WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE AND THAT THE SURGEON'S DECISION TO COVERT TO OPEN SURGICAL TECHNIQUES WAS DUE TO THE SIZE OF THE PATIENT'S LESION. THE SURGEON FOUND THAT THE LESION WAS LARGER THAN HE EXPECTED AND THAT THE SURGEON BELIEVED THAT THE LESION WAS TOO COMPLEX TO BE REMOVED ROBOTICALLY. THE CSR INDICATED THAT DURING HIS ATTENDANCE OF DA VINCI SURGICAL PROCEDURE HE DID NOT WITNESS ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES WHILE THEY WERE IN USE. THE CSR INDICATED THAT THERE WAS NO ALLEGATION BY THE SITE THAT THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS, OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. PER THE CSR, HE WAS NOT PRESENT DURING THE OPEN PROCEDURE AND THAT THE CAUSE OF THE PATIENT'S DEMISE WAS NOT PROVIDED TO HIM BY THE SITE. THE CSR INDICATED THAT HE WAS TOLD BY THE SITE'S VICE-PRESIDENT THAT THE MEDICAL EXAMINER DECLINED TO INVESTIGATE THE REPORTED EVENT TO DETERMINE THE CAUSE OF THE PATIENT'S DEMISE. ON (B)(4) 2013, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER DECLINED TO PROVIDE A CAUSE OF DEATH FOR THE PATIENT OR ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ISI'S REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND NO SYSTEM ERRORS WERE GENERATED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE." } ], "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": "05/20/2013" } ] }