{ "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": "2955842-2011-00019", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20110114", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101217", "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": [ "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20110922", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20110114", "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 A6.0P5", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Unintended Collision", "Human-Device Interface Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20110114", "sequence_number_treatment": [ "DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "75 YR", "patient_sex": "", "patient_weight": "75", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20130121", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1961862", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20101217", "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": "8813544", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT MTM MOVEMENT EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH USE ERROR. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE GUIDED TOOL CHANGE IS AN EFFICIENT AND SAFE METHOD FOR INSTRUMENT INSERTION, PROVIDING ASSISTANCE TO THE PATIENT SIDE CART OPERATOR BY GUIDING THE INSTRUMENT INTO THE PATIENT. THE SYSTEM WAS FOUND TO BE WITHIN SPECIFICATION, HOWEVER, GRAVITY CALIBRATION WAS PERFORMED ON THE MTMS AS A PRECAUTION. ON (B)(6) 2010, ADDITIONAL TRAINING WAS CONDUCTED WITH THE SURGEON TO ENSURE THAT IN FUTURE CASES, HE WILL REMOVE HIS HEAD FROM THE SURGEON SIDE VIEWER WHEN HIS HANDS ARE NOT ENGAGED ON THE MTMS. THE DA VINCI SI USER MANUAL SPECIFICALLY STATES: NOTE: FOR GUIDED TOOL CHANGE, THE SURGEON SHOULD REMOVE THEIR HEAD FROM THE STEREO VIEWER TO TAKE ALL INSTRUMENTS OUT OF FOLLOWING BEFORE REMOVING AND INSTALLING AN INSTRUMENT. AS OF JANUARY 13, 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL." }, { "mdr_text_key": "17755878", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "1783878", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY 2 HOURS DURING A DA VINCI SI RECTOPEXY PROCEDURE, WHILE AN INSTRUMENT CHANGE WAS IN PROGRESS, THE SURGEON REMOVED HIS HANDS FROM THE MASTER TOOL MANIPULATORS (MTM); HOWEVER; LEFT HIS HEAD IN THE SURGEON SIDE STEREO VIEWER. THIS CAUSED THE INSTRUMENT BEING EXCHANGED IN THE GUIDED TOOL CHANGE MODE, TO MOVE SLIGHTLY FORWARD AND BUMP THE PATIENT'S COLON. SLIGHT BLEEDING OF THE PATIENT'S COLON OCCURRED; HOWEVER, NO REPAIR, BLOOD TRANSFUSION OR INTERVENTION WAS NECESSARY. THE PLANNED PROCEDURE WAS COMPLETED AND NO ADVERSE OUTCOME WAS REPORTED." } ], "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": "01/22/2013" } ] }