{ "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": "Injury", "report_number": "2955842-2016-00332", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160513", "manufacturer_address_2": "", "pma_pmn_number": "K063220", "date_of_event": "20151202", "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": "20160513", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "308296", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160513", "brand_name": "DA VINCI S 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": "IS2000", "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": [ "Leak/Splash" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20160513", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Aspiration/Inhalation", "Death", "Discharge", "Aspiration/Inhalation", "Death", "Discharge" ] } ], "distributor_city": "", "date_report": "20160504", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5654656", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160504", "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": "45199885", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE PATIENT'S REPORTED LEAK IS UNKNOWN. THE TYPE OF LEAK IS UNKNOWN. IN ADDITION, THE DETAILS REGARDING THE STENTING THAT WAS PERFORMED AS A RESULT OF THE UNSPECIFIED LEAK ARE UNKNOWN. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE. 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) 2015. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. NO DA VINCI STAPLER INSTRUMENTS OR ACCESSORIES WERE USED DURING THE SURGICAL PROCEDURE ACCORDING TO THE SYSTEM LOGS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF THE DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, THE PATIENT WAS READMITTED TO A HOSPITAL ON POST-OPERATIVE DAY 24 AND RECEIVED TREATMENT FOR AN UNSPECIFIED LEAK. ALTHOUGH THE PATIENT SUBSEQUENTLY PASSED AWAY APPROXIMATELY 3 MONTHS LATER DUE TO ASPIRATION, THE SURGEON INDICATED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI-ASSISTED SURGICAL PROCEDURE." }, { "mdr_text_key": "45199886", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE PERFORMED ON (B)(6) 2015, THE PATIENT WAS READMITTED TO A HOSPITAL ON (B)(6) 2015 WHERE HE RECEIVED UNSPECIFIED TREATMENT FOR AN UNSPECIFIED LEAK. THE PATIENT REPORTEDLY PASSED AWAY IN (B)(6) 2016 FROM AN UNKNOWN CAUSE. HOWEVER, ACCORDING TO THE INITIAL REPORTER, THE SURGEONS WERE NOT ATTRIBUTING THE PATIENT'S DEATH TO THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ON 05/06/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. THE DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE WAS COMPLETED AND THE PATIENT INITIALLY DID VERY WELL. ON 05/10/2016 AND 05/11/2016, THE INITIAL REPORTER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AFTER SPEAKING TO THE SURGEON: THE SURGEON WAS UNABLE TO PROVIDE DETAILS AS TO WHAT TYPE OF LEAK WAS IDENTIFIED. HE DID NOT KNOW IF THE LEAK WAS FROM AN ANASTOMOSIS OR A STAPLE LINE. THE SURGEON INDICATED THAT HE WAS HAPPY WITH THE DA VINCI-ASSISTED SURGICAL PROCEDURE AND THE ANASTOMOSIS THAT WAS CREATED INTRA-OPERATIVELY USING ROBOTIC INSTRUMENTATION. AS A RESULT OF THE UNSPECIFIED LEAK, THE PATIENT WAS REPORTEDLY STENTED AFTER BEING READMITTED TO A HOSPITAL. ON AN UNSPECIFIED DATE IN (B)(6) 2016, THE PATIENT PASSED AWAY. AN AUTOPSY WAS PERFORMED BUT THE SURGEON DID NOT HAVE THE AUTOPSY REPORT READILY AVAILABLE. THE SURGEON INDICATED THAT THE CAUSE OF THE PATIENT'S DEATH WAS DUE TO ASPIRATION. HE REITERATED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE. PRIOR TO UNDERGOING THE SURGICAL PROCEDURE, THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }