{ "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": "2955842-2014-05573", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141030", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140912", "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": "20141030", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "696838", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141030", "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": [ "Failure to Sense" ], "reporter_state_code": "OR", "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": "20141030", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Fever" ] } ], "distributor_city": "", "date_report": "20141003", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4215147", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141003", "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": "18115925", "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 POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT AND THE PATIENT'S SUBSEQUENT DEMISE. IN ADDITION, THE DATE OF THE PATIENT'S DEATH IS UNKNOWN. 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. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014 REVEALED THAT THE SURGICAL STAFF ENCOUNTERED SYSTEM ERROR CODES 23005 AND 32003 DURING THE PROCEDURE. A SYSTEM ERROR CODE 23005 IS A RECOVERABLE ERROR THAT SIGNIFIES THAT THE SERVO SYSTEM DETECTED A CONDITION WHERE IT WAS GENERATING AN UNEXPECTEDLY HIGH AMOUNT OF OUTPUT POWER. THIS CAN OCCUR WHEN ARMS COLLIDE WITH ONE ANOTHER OR SOMETHING ELSE IN THE ENVIRONMENT. WHEN NO COLLISIONS AND/OR RAPID MOVEMENT WERE INVOLVED, IT MAY REPRESENT AN ENCODER FAILURE OR A COMPUTATIONAL ERROR ON THE REMOTE ARM CONTROLLER (RAC). AN ERROR CODE 32003 SIGNIFIES THAT THE SYSTEM DETECTED THAT THE VESSEL SEALER INSTRUMENT WAS NOT ABLE TO DRIVE THE CUTTING BLADE ACROSS THE FULL RANGE OF TRAVEL DURING A CUT COMMAND. THIS COULD BE CAUSED BY A DIRTY VESSEL SEALER INSTRUMENT OR ATTEMPTING TO CUT VERY THICK AND/OR UNSEALED TISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT DEVELOPED A FEVER 2 WEEKS POST-OPERATIVELY AND SUBSEQUENT PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION AND HIS SUBSEQUENT DEMISE ARE UNKNOWN." }, { "mdr_text_key": "17989147", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI RIGHT TRANSVERSE COLECTOMY PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT (ED) 2 WEEKS POST-OPERATIVELY WITH SYMPTOMS OF A FEVER. THE PATIENT SUBSEQUENTLY PASSED AWAY WITH UNKNOWN ETIOLOGY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THERE WERE NO SIGNS OF AN ADVERSE EVENT AT THE TIME OF SURGERY AND SHORTLY THEREAFTER. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING PART OF THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE CSR, HE WAS PRESENT DURING SETUP OF THE PROCEDURE AND UP UNTIL ABOUT HALF WAY THROUGH COMPLETION OF THE SURGERY. THE CSR INDICATED THAT DURING THE PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN ISSUE AT ONE POINT WHERE PATIENT SIDE MANIPULATOR (PSM) 1 DID NOT RECOGNIZE AN INSTRUMENT. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE CSR STATED THAT THE SURGICAL STAFF SWAPPED INSTRUMENTS BETWEEN THE PSMS AND EVERYTHING WORKED PROPERLY FROM THAT POINT ON. DURING THE TIME THE CSR WAS PRESENT DURING THE PROCEDURE, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OBSERVED. THE CSR WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT." } ], "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": "" } ] }