{ "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": "2955842-2014-05149", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140822", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140722", "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": "20140822", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "510214", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140822", "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": "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20140822", "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", "Cardiopulmonary Arrest", "Death", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20140725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4031311", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141010", "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": "18931411", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HEMICOLECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 1. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT SHE WAS PRESENT DURING PART OF THE DA VINCI SURGICAL PROCEDURE AND THE SURGEON PERFORMED EXTRA CAUTERIZATION ON THE PATIENT'S COLON USING A LAPAROSCOPIC STAPLER INSTRUMENT. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT SHE WAS PRESENT DURING THE FIRST HALF OF THE DA VINCI SURGICAL PROCEDURE AND THE CASE WENT WELL. ON POST-OPERATIVE DAY 1, THE PATIENT PRESENTED WITH SYMPTOMS OF AN ANASTOMOTIC LEAK. AT AN UNSPECIFIED TIME THAT SAME DAY, THE PATIENT CODED AND WAS THEN STABILIZED. LATER, THAT SAME DAY, THE PATIENT CODED AGAIN AND THEN SUBSEQUENTLY PASSED AWAY. THE INITIAL REPORTER STATED THAT THE SURGEON DID NOT USE A STAPLER INSTRUMENT MANUFACTURED BY ISI. SHE STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER SPOKE TO THE SURGEON REGARDING THE REPORTED EVENT AND WAS INFORMED THAT THE ANASTOMOTIC SITE WAS HAND-SEWN. ACCORDING TO THE INITIAL REPORTER, IT IS THE SURGEON'S BELIEF THAT THE PATIENT PASSED AWAY AS A RESULT OF HAVING AN INTERNAL BLEED AT THE ANASTOMOTIC SITE THAT WAS NOT VISIBLE AND DETECTED. THE INITIAL REPORTER STATED THAT THE PATIENT'S AUTOPSY REPORT IS CURRENTLY PENDING." }, { "mdr_text_key": "18313982", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SITE'S RISK MANAGEMENT DEPARTMENT. ACCORDING TO THE RISK MANAGER, THE SURGEON PROVIDED THE FOLLOWING INFORMATION: THE CASE WAS A DA VINCI RIGHT HEMICOLECTOMY PROCEDURE. THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. A DA VINCI STAPLER INSTRUMENT WAS NOT USED DURING THE SURGICAL PROCEDURE. THE ANASTOMOSIS WAS STAPLED WITH A 100 MM ETHICON STAPLER INSTRUMENT. ACCORDING TO THE SURGEON, A LEAK TEST WAS NOT PERFORMED SINCE THE CASE WAS A RIGHT-SIDED ANASTOMOSIS. THE SURGEON INDICATED THAT THE SITE OF THE BLEED WAS ON THE STAPLE LINE; HOWEVER, THE SOURCE OF THE BLEED IS UNKNOWN SINCE THE PATIENT PASSED AWARE PRIOR TO GOING BACK TO SURGERY. THE SURGEON BELIEVES THE CAUSE OF THE PATIENT'S DEATH WAS ACUTE BLOOD LOSS." }, { "mdr_text_key": "19131880", "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 OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT A DA VINCI HEMICOLECTOMY PROCEDURE, WAS FOUND TO HAVE SUSTAINED AN ANASTOMOTIC LEAK POST-OPERATIVELY, AND PASSED AWAY ON POST-OP DAY 1. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION AND SUBSEQUENT DEMISE IS UNKNOWN." } ], "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": "11/07/2014" } ] }