{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2020-10262", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200402", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20200226", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20200402", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20191205", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "380756", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200402", "brand_name": "DA VINCI", "generic_name": "8 MM FENESTRATED BIPOLAR FORCEPS", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "470205-17", "catalog_number": "470205", "lot_number": "N10191209", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00886874112359", "udi_public": "(01)00886874112359(10)N10191209", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Unintended System Motion", "Adverse Event Without Identified Device or Use Problem", "Unintended System Motion", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/03/2020", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250807", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20200402", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Injury", "Blood Loss", "Hemorrhage/Blood Loss/Bleeding", "Injury", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20200303", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "9918537", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200303", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "329475446", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "329475447", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST AN ADVERSE EVENT AS PREVIOUSLY REPORTED DUE TO THE REPORT OF THE PATIENT¿S HEART WAS DAMAGED AND BLEEDING WAS OBSERVED. AS A RESULT, UNSPECIFIED MEDICAL INTERVENTION WAS ADMINISTERED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-EVALUATED. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELDS: B1, H6. B1 UPDATED FROM \"ADVERSE EVENT\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". ANNEX E UPDATED TO INCLUDE TO E0506 - HEMORRHAGE/BLEEDING. ANNEX F UPDATED TO INCLUDE F23 - UNEXPECTED MEDICAL INTERVENTION AND F08 - HOSPITALIZATION OR PROLONGED HOSPITALIZATION. ANNEX A UPDATED TO INCLUDE F08 - HOSPITALIZATION OR PROLONGED HOSPITALIZATION. ANNEX B UPDATED TO INCLUDE B17 - DEVICE NOT RETURNED AND B15 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY. ANNEX C UPDATED TO INCLUDE C20 - NO FINDINGS AVAILABLE. ANNEX D UPDATED TO INCLUDE D15 - CAUSE NOT ESTABLISHED." }, { "mdr_text_key": "196554016", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S INTRA-OPERATIVE COMPLICATION IS UNKNOWN. IT IS ALSO UNCLEAR WHAT TASK WAS BEING PERFORMED BY THE SURGICAL STAFF WHEN THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS IN CONTACT WITH THE PERICARDIUM. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT AND REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS REVIEWED A VIDEO CLIP, PROVIDED BY THE SITE, OF THE SURGICAL PROCEDURE IN QUESTION. PER THE VIDEO CLIP, IT CAN BE CONFIRMED THAT THE USER FIRST PRESSED A CLUTCH BUTTON, THEN THE CANNULA MOUNT GUI MESSAGE APPEARED. THE ARM POD MESSAGE DISPLAYED COULD RESULT FROM EITHER AN INSTRUMENT CLUTCH OR A PORT CLUTCH. FROM THE VIDEO ALONE, IT CANNOT BE CONFIRMED WHY THE CANNULA DISCONNECTED FROM THE CANNULA MOUNT AS INSTRUMENT CLUTCHING SHOULD NOT CAUSE THIS. HOWEVER, THE MOVEMENT OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS THE RESULT OF THE INSTRUMENT ARM BEING CLUTCHED AND THE CANNULA BEING DISCONNECTED FROM THE ROBOT AS THE USER ATTEMPTED TO REMOVE THE INSTRUMENT. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020. THE SYSTEM LOGS REVEAL THAT A SINGLE FENESTRATED BIPOLAR FORCEPS INSTRUMENT (PART # 470205-17; LOT # N10190110-0052) WAS USED DURING THE CASE AND HAS BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES. THE SYSTEM LOGS REVEAL THAT THE CANNULA RELEASE LEVER WAS PRESSED DOWN (¿RELEASED¿) AND THE PORT CLUTCH WAS PRESSED. THE DA VINCI XI SYSTEM USER MANUAL STATES THE FOLLOWING IN RELATION TO INSTRUMENT REMOVAL: ¿BEFORE REMOVING AN INSTRUMENT, MAKE SURE THE SURGEON IS READY. CAUTION: REMOVING INSTRUMENTS DURING A PROCEDURE SHOULD BE PERFORMED VERY CAREFULLY AND ONLY WHEN THE SURGEON CONSOLE OPERATOR IS INFORMED OF THE REMOVAL AND HAS THE INSTRUMENT IN FULL VIEW. DO NOT REMOVE THE INSTRUMENT IF IT IS NOT IN VIEW. CAUTION: BEFORE REMOVING AN INSTRUMENT ENSURE THAT THE TIPS ARE NOT GRASPING TISSUE. CAUTION: ANY LATERAL PRESSURE ON THE INSTRUMENT DURING REMOVAL MAY DAMAGE THE INSTRUMENT. PRIOR TO REMOVING THE INSTRUMENT, THE SURGEON CONSOLE OPERATOR SHOULD: ENSURE THE INSTRUMENT IS FREE AND CLEAR OF ANY PATIENT ANATOMY. STRAIGHTEN THE INSTRUMENT WRIST. CLEARLY COMMUNICATE TO THE PATIENT CART OPERATOR WHICH INSTRUMENT TO REMOVE. IDENTIFY THE NAME OF THE INSTRUMENT OR THE NUMBER OF THE ARM (1, 2, 3, 4). TO REMOVE THE INSTRUMENT: ENSURE THE INSTRUMENT IS POSITIONED FOR REMOVAL. SQUEEZE THE INSTRUMENT RELEASE BUTTONS AND SLIDE THE INSTRUMENT UP AND OUT THROUGH THE CANNULA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED MEDIASTINAL TUMOR RESECTION PROCEDURE, THE PATIENT¿S HEART WAS DAMAGED AND BLEEDING WAS OBSERVED. AS A RESULT, UNSPECIFIED MEDICAL INTERVENTION WAS ADMINISTERED. HOWEVER, AT THIS TIME, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN OR UNAVAILABLE. THE EXPIRATION DATE NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE, NOT AVAILABLE FOR THE SITE." }, { "mdr_text_key": "196554017", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL TUMOR RESECTION PROCEDURE, THE BLADE OF THE VESSEL SEALER (VS) INSTRUMENT WAS EXPOSED AND THE SYSTEM GENERATED AN ERROR MESSAGE. A BACKUP VS INSTRUMENT WAS USED TO CONTINUE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. IN ADDITION, THERE WERE NO INITIAL REPORTS OF ANY PATIENT HARM OR INJURY. ON 03-MAR-2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION FROM A NURSE AT THE SITE INDICATING THAT ¿THERE WAS BLEEDING AND THE TREATMENT TOOK TIME.¿ ON 16-MAR-2020, ISI RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AFTER REMOVING THE LONGITUDINAL TUMOR AND THE ROBOT WAS UNDOCKED, THE ANESTHESIOLOGIST NOTICED THAT THE PATIENT¿S BLOOD PRESSURE HAD DROPPED DURING INTRATHORACIC EXAMINATION. THE ALLEGED CAUSE OF THE DECREASE IN BLOOD PRESSURE WAS DAMAGE TO THE HEART AND BLEEDING. WHEN THE CONSOLE SURGEON CHECKED THE PROCEDURE VIDEO WITH A CARDIOVASCULAR SURGEON, IT WAS SPECULATED THAT THE MOVEMENT OF AN ARM MIGHT HAVE BEEN THE CAUSE. UPON REVIEW OF THE VIDEO BY THE SURGEON AND AN ISI REPRESENTATIVE, IT WAS NOTED THAT THERE WAS AN IMAGE THAT SHOWED A FENESTRATED BIPOLAR FORCEPS INSTRUMENT ¿LARGELY RUBBING THE PERICARDIUM AND MOVING.¿ AT THAT TIME, THE FOLLOWING SYSTEM MESSAGE PRESENTED: \"ENSURE CANNULA MOUNT IS PROPERLY CLOSED.¿ THE SURGEON ASKED WHAT THE MOVEMENT WAS. IT WAS EXPLAINED TO THE SURGEON THAT BASED ON THE TIMING OF THE MESSAGE, THE PORT CLUTCH BUTTON WAS PRESSED FIRST DURING ATTEMPTS TO REMOVE THE INSTRUMENT. THE SURGEON ALSO CONCLUDED THAT THE VS INSTRUMENT WAS NOT INVOLVED WITH THE INTRA-OPERATIVE COMPLICATION BASED ON THE LOCATION OF DAMAGE TO THE HEART. THE PATIENT IS CURRENTLY NOT EXPECTED TO BE DISCHARGED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/23/2022" } ] }