{ "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": "2955842-2023-13052", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230512", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230329", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230512", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190522", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1357364", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230512", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-34", "catalog_number": "380601", "lot_number": "N/A", "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": "00886874114605", "udi_public": "(01)00886874114605", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/15/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250727", "health_professional": "Y", "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": "20230512", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "64 YR", "patient_sex": "Female", "patient_weight": "48 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Adult Respiratory Distress Syndrome", "Low Oxygen Saturation", "Adult Respiratory Distress Syndrome", "Low Oxygen Saturation" ] } ], "distributor_city": "", "date_report": "20230419", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16921043", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230419", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "338894984", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS OBTAINED AS THE FOLLOWING: THE PATIENT WAS DIAGNOSED WITH ACUTE HYPOXIC RESPIRATORY FAILURE AND ACUTE HYPERCARBIA RESPIRATORY FAILURE AFTER TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT WAS PLACED ON AN AEROSOLIZED MASK AT 15L 40% FIO2 AND STARTED ON VANCOMYCIN. AS OXYGEN REQUIREMENTS CONTINUED TO INCREASE, DECISION WAS MADE TO INTUBATE ON (B)(6) 2023 AT 06:00AM. THE PATIENT WAS ALSO FOUND WITH POST-OPERATIVE ANEMIA, WHICH HER HEMOGLOBIN LEVEL DROPPED FROM 9.1 TO 7.3. THE PATIENT HAD HEMODILUTION AND EXCESSIVE PHLEBOTOMY AND WAS GIVEN 1 UNIT OF PACKED RED BLOOD CELLS IN THE ICU. THE PATIENT RESPONDED WELL TO THE TREATMENT AND WAS SUCCESSFULLY EXTUBATED ON (B)(6) 2023 AT 12:37PM TO 2-4 L OXYGEN NASAL CANNULA. NO POSITIVE CULTURE TO CONFIRM ASPIRATION PNEUMONIA AND THUS VANCOMYCIN WAS DISCONTINUED. THE PATIENT WAS DISCHARGED ON (B)(6) 2023. ANNEX B13 - (COMMUNICATION/INTERVIEWS) WAS ADDED AS FOLLOW-UP WAS COMPLETED." }, { "mdr_text_key": "338894985", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "315113770", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE ACUTE RESPIRATORY DISTRESS SYNDROME CANNOT BE DETERMINED. THERE IS NO REPORT OF A DA VINCI PRODUCT ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A SYSTEM LOG SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA-VINCI ASSISTED PULMONARY LOBECTOMY, THE PATIENT EXPERIENCED INCREASED SHORTNESS OF BREATH RESULTING IN HIGHER OXYGEN REQUIREMENTS AND LOWER OXYGEN SATURATION IN THE LOW TO MID 80S ON 10 LITER OXYGEN HIGH FLOW NASAL CANULA. THIS REQUIRED A HIGHER LEVEL OF CARE AND THE PATIENT WAS ADMITTED TO ICU WITH ACUTE RESPIRATORY FAILURE. PATIENT WAS INTUBATED AS OXYGEN NEED CONTINUED TO INCREASE. THERE WAS NO REPORT OF MALFUNCTIONS OF ANY DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES." }, { "mdr_text_key": "315114147", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI-ASSISTED PULMONARY LOBECTOMY ON (B)(6) 2023 AS PART OF THE SP THORACIC IDE STUDY. ON (B)(6) 2023, THE PATIENT EXPERIENCED INCREASED SHORTNESS OF BREATH RESULTING IN HIGHER OXYGEN REQUIREMENTS. THE PATIENT HAD LOWER OXYGEN SATURATION IN THE LOW TO MID 80S AND WAS PLACED ON 10 LITER OXYGEN HIGH FLOW NASAL CANULA. THE REPORTED EVENT REQUIRED A HIGHER LEVEL OF CARE AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU)WITH ACUTE RESPIRATORY FAILURE. AS OXYGEN REQUIREMENTS CONTINUED TO INCREASE, THE DECISION WAS MADE TO INTUBATE THE PATIENT ON (B)(6) 2023 AT 06:00 AM. THE PATIENT WAS SUCCESSFULLY EXTUBATED ON (B)(6) 2023 AT 12:37 PM TO A 2-4 LITER OXYGEN NASAL CANNULA. THE PATIENT WAS DISCHARGED ON (B)(6) 2023. THERE WAS NO MALFUNCTION OF AN INTUITIVE SURGICAL, INC. (ISI) SYSTEM, INSTRUMENT, OR ACCESSORY DEVICE REPORTED. THE PATIENT ALSO HAD A NON-ROBOTIC RIGHT THORACOSCOPY WITH MEDIASTINAL AND REGINAL LYMPHADENECTOMY AS A CONCOMITANT PROCEDURE. THE STUDY INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE DA VINCI-ASSISTED SURGERY BUT NOT RELATED TO THE DA VINCI DEVICES. THE STUDY INVESTIGATOR BELIEVED THAT THE EVENT IS A POSSIBLE COMMON SEQUALAE OF SUCH SURGERY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/08/2023" } ] }