{ "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": "2955842-2013-04378", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131011", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130903", "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": "20131015", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "521711", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131011", "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 A6.0P8", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20131011", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "175", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Death" ] } ], "distributor_city": "", "date_report": "20130911", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3407044", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130911", "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": "3908187", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SI SIGMOID COLECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, A PATIENT SUBSEQUENTLY EXPIRED 7 DAYS LATER ON (B)(6)2013. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON PERFORMED AN ANASTOMOSIS DURING THE SURGICAL PROCEDURE AND A LEAK WAS FOUND AFTER A LEAK TEST WAS DONE. AFTER THE SURGEON REPAIRED THE LEAK BY APPLYING SUTURES, ANOTHER LEAK TEST WAS PERFORMED AND NO FURTHER COMPLICATIONS WERE FOUND. THE SURGICAL PROCEDURE WAS COMPLETED. THE DAY AFTER SURGERY, THE PATIENT WAS REPORTEDLY DOING FINE. HOWEVER, OVER THE FOLLOWING WEEKEND, THE PATIENT WAS NOT DOING WELL. ACCORDING TO THE INITIAL REPORTER, A CT SCAN WAS PERFORMED ON THE PATIENT ON (B)(6) 2013, AND NO ISSUES WERE SEEN. THE INITIAL REPORTER INDICATED, HOWEVER, THAT AN ANASTOMOSIS DYE TEST WITH X-RAY WAS PERFORMED AND A LEAK WAS SEEN. THE PATIENT WAS RUSHED TO SURGERY AND THE PATIENT EXPIRED IN THE OPERATING ROOM (OR)." }, { "mdr_text_key": "11117145", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S DEMISE. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(4) 2013, ISI CONTACTED THE SURGEON WHO PERFORMED THE DA VINCI SI SIGMOID COLECTOMY PROCEDURE. THE SURGEON STATED THAT THERE WERE NO ISSUES WITH THE DA VINCI SI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE. HE INDICATED THAT NO MALFUNCTION OF THE SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON ALSO STATED THAT THE PATIENT WAS EXTREMELY OBESE (B)(6) AND THE PATIENT WOULD NOT HAVE DONE WELL IF THE SIGMOID COLECTOMY PROCEDURE WAS PERFORMED VIA OPEN SURGERY OR TRADITIONAL LAPAROSCOPIC TECHNIQUES. THE SURGEON ALSO STATED THAT THE PATENT WAS DOING GREAT THE DAY AFTER SURGERY. HOWEVER, ON AN UNSPECIFIED DATE POST-OP, THE PATIENT BEGAN TO DEVELOP RESPIRATORY ISSUES. THE SURGEON INDICATED THAT AN X-RAY WAS PERFORMED AND ANOTHER LEAK WAS FOUND. HOWEVER, THE SURGEON COULD NOT RECALL EXACTLY WHERE THE LEAK WAS. THE SURGEON STATED THAT THE PATIENT WAS RUSHED TO THE OR WHERE HE STOPPED BREATHING AND WAS INTUBATED. DUE TO HYPOXIA, THE SURGEON STATED THAT THE PATIENT'S HEART STOPPED AND THE PATIENT EXPIRED. THE SURGEON STATED THAT THE DA VINCI SI SURGICAL SYSTEM DID NOT CAUSE THE PATIENT'S DEMISE. ON (B)(4) 2013, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER WAS UNABLE TO PROVIDE A CAUSE OF DEATH FOR THE PATIENT. THE RISK MANAGER STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE PLANNED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPIRED 7 DAYS AFTER COMPLETION OF A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEMISE IS UNKNOWN AND THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE." } ], "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": "" } ] }