{ "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": "2955842-2023-19149", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20231012", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20191113", "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", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20231012", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1312637", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231012", "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", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20231012", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20230916", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17924348", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230916", "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": "325570193", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A REVIEW OF THE SYSTEM AND DEVICE LOGS COULD NOT BE COMPLETED AT THIS TIME, DUE TO INSUFFICIENT EVENT AND SITE INFORMATION." }, { "mdr_text_key": "325570194", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SINGLE-PORT (SP) EXTRAPERITONEAL PROSTATECTOMY PROCEDURE, THE PATIENT PRESENTED WITH A PNEUMOTHORAX. THIS WAS ONE OF THE SURGEON'S FIRST DA VINCI-ASSISTED SP CASES, AND THE DA VINCI AXIS PORT WAS NOT AVAILABLE BACK THEN. AS SUCH, THE SURGEON USED A MODIFIED 3RD PARTY GELPORT THAT THEY LEFT SLIGHTLY UNRAVELED IN ORDER TO ALLOW SOME ADDITIONAL ACCESS/WORKING SPACE. HOWEVER, THIS DID NOT CREATE A GREAT SEAL. HE BELIEVES THE CO2 TRAVELED UP THE RECTUS SHEATH TO THE MEDIASTINUM, AND THEN CAUSED THE PNEUMOTHORAX. FROM HIS RECOLLECTION, THE PATIENT PRESENTED WITH POST-OPERATIVE RESPIRATORY CONCERNS, LIKELY DYSPNEA, AND A CHEST X-RAY CONFIRMED THE PNEUMOTHORAX. THEY PUT IN A CHEST TUBE AND INVOLVED A PULMONOLOGIST, WHO MANAGED THAT ASPECT OF THE PATIENT'S CARE. THERE MAY HAVE BEEN SOME EXTRA HOSPITALIZATION, BUT THE PATIENT RECOVERED WELL, WITH NO SEQUELAE. THE SURGEON BELIEVED THE EXTRAPERITONEAL APPROACH MAY HAVE ALSO CONTRIBUTED TO THIS COMPLICATION, AS SOME PATIENTS CAN DEVELOP SUBCUTANEOUS EMPHYSEMA FROM CO2 WITH THIS KIND OF APPROACH. HE THOUGHT THAT THE PRESSURE THAT THEY WERE USING COULD HAVE ALSO BEEN TOO HIGH, WHICH MAY HAVE CONTRIBUTED TO THE ISSUE. THEIR SETUP INCLUDED THE USE OF A 3RD PARTY AIRSEAL DEVICE. NO MALFUNCTION OF THE DA VINCI SP SYSTEM OR DEVICES OCCURRED." } ], "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": "" } ] }