{ "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": "2955842-2015-01342", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20151030", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150709", "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 REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20151030", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "723164", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20151030", "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 A6.0P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20151030", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Nausea", "Sepsis", "Peritonitis", "Collapse", "Alteration In Body Temperature" ] } ], "distributor_city": "", "date_report": "20150716", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5192833", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150716", "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": "30014351", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE PERIOPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. ACCORDING TO THE INITIAL REPORTER, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(4) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S OPERATIVE COMPLICATIONS. THE THREE DA VINCI INSTRUMENTS USED DURING THE REPORTED SURGICAL PROCEDURE HAVE BEEN USED IN SUBSEQUENT OPERATIONS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT EXPIRED ON POST-OPERATIVE DAY 2. HOWEVER, THE CAUSES OF THE PATIENT'S PERIOPERATIVE COMPLICATIONS ARE UNKNOWN." }, { "mdr_text_key": "30014352", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 2. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INTUITIVE SURGICAL EMPLOYEE WHO INITIALLY REPORTED THE COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: ON (B)(6) 2015, A PATIENT WITH A BIG, LATE T3/T4 GRADE TUMOR LOCATED IN THE LOWER RECTUM UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE IN ORDER TO REMOVE THE TUMOR. DURING THE PROCEDURE, A SMALL ANASTOMOTIC LEAK WAS IDENTIFIED AFTER A LEAK TEST WAS PERFORMED. THE SURGEON WAS NOT SURE WHAT CAUSED THE ANASTOMOTIC LEAK. IT WAS INDICATED THAT A NON-ISI STAPLER INSTRUMENT HAD BEEN USED TO CREATE THE ANASTOMOSIS. THE PATIENT'S ABDOMEN WAS CLEANED WITH BETADINE AND A PROTECTIVE ILEOSTOMY WAS PLACED. ANTIBIOTICS WERE ALSO ADMINISTERED. ACCORDING TO THE INITIAL REPORTER, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. THE INITIAL REPORTER ALSO INDICATED THAT THERE WERE NO ISSUES WITH ANESTHESIA. AFTER THE TUMOR WAS REMOVED AND THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS AWAKENED AS NORMAL. ON POST-OPERATIVE DAY 1, THE PATIENT EXPERIENCED COMPLICATIONS RELATED TO TEMPERATURE REGULATION, NAUSEA, AND COLLAPSING. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE DEPARTMENT. THAT SAME DAY, THE PATIENT WAS TAKEN BACK TO THE OR AND UNDERWENT OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF COULD NOT FIND ANY OBVIOUS SIGNS OF BLEEDING, LEAKAGE, OR PERITONITIS. THE INITIAL REPORTER INDICATED THAT THE PATHOLOGIST DID NOT FIND ANY EVIDENCE OF A VESSEL INJURY, URETER DAMAGE, OR BOWEL PERFORATION. FURTHER ANALYSIS REVEALED THAT THE SEPSIS WAS PROBABLY CAUSED BY A TUMOR PERFORATION. THE CAUSE OF DEATH AS DETERMINED BY THE SITE WAS ACUTE SEPSIS. THE SURGEON INDICATED THAT PRIOR TO SURGERY, THE PATIENT WAS A SMOKER AND DEALING WITH HIGH DIABETES AND MALNUTRITION. ON (B)(6) 2015, THE INITIAL REPORTER PROVIDED THE FOLLOWING INFORMATION AFTER SPEAKING TO THE SURGEON ON AN UNSPECIFIED DATE: THE SURGEON BELIEVES THE PERFORATION OF THE TUMOR PROBABLY OCCURRED DURING DISSECTION AND WHILE PULLING THE RECTUM. THE SURGEON ALSO MENTIONED THAT THE TUMOR MAY HAVE ACTUALLY BEEN PERFORATED PRIOR TO THE SURGERY AND HAD HEALED NATURALLY. HOWEVER, THROUGH THE MANIPULATION OF THE RECTUM DURING SURGERY, THE TUMOR MAY HAVE POSSIBLY PERFORATED AGAIN. THE SURGEON NOTED THAT PERITONITIS TYPICALLY OCCURS ON THE 3RD OR 4TH DAY AFTER A PERFORATION OCCURS. IN THIS CASE, PERITONITIS WAS OBSERVED ON POST-OPERATIVE DAY 1." } ], "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": "" } ] }