{ "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": "2955842-2023-19150", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20231012", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "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": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1506732", "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": "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": [ "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": "10/12/2023;11/11/2023", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "Unknown", "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": "17924659", "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": "338349248", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "338349249", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PER THE INITIAL REPORTER'S COLLEAGUE, THE ISSUE OCCURRED WHILE USING THE INTUITIVE SURGICAL, INC. (ISI) ACCESS PORT, NOT A 3RD-PARTY GEL PORT AS INITIALLY REPORTED. NO FURTHER DETAILS WERE PROVIDED." }, { "mdr_text_key": "338688446", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SURGEON FOR THE PROCEDURE RESPONDED TO A REQUEST FOR ADDITIONAL INFORMATION. PER THE SURGEON, THE PROCEDURE WAS A ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY (RALP) WITH PELVIC LYMPH NODE DISSECTION (PLND). HE USED AN EXTRAPERITONEAL APPROACH FOR THE PROCEDURE. THE PNEUMOTHORAX WAS IDENTIFIED AFTER THE PROCEDURE WAS COMPLETED VIA AN X-RAY. THE INITIAL SIZE OF THE PNEUMOTHORAX WAS <2CM, AND IT DID NOT INCREASE OVER TIME. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE PNEUMOTHORAX, AND NO MEDICAL INTERVENTIONS, INCLUDING A CHEST TUBE, WERE REQUIRED. THE PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION AS A RESULT OF THIS ISSUE; THE PATIENT WAS UNDER OBSERVATION FOR <24 HOURS ONLY. THERE WERE NO CONCERNS FOR THE PATIENT LONG-TERM AS A RESULT OF THIS EVENT. NO OTHER INTRA- AND/OR POST-OPERATIVE COMPLICATIONS OCCURRED. NO MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED PRIOR TO OR AT THE TIME OF THE EVENT. THE SURGEON DID NOT BELIEVE THAT THE SP SYSTEM AND/OR ANY OTHER ISI DEVICE/ACCESSORY CAUSED OR CONTRIBUTED TO THE PNEUMOTHORAX. RATHER, HE BELIEVED THE INSUFFLATION PRESSURE CAUSED THE EVENT. TO HIS KNOWLEDGE, THIS ISSUE WAS NOT REPORTED TO AN ISI REPRESENTATIVE AT THE TIME OF THE EVENT. HE COULD NOT PROVIDE THE PROCEDURE DATE OR THE START TIME OF THE PROCEDURE." }, { "mdr_text_key": "338688447", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "325531575", "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. THE PRODUCT HAS NOT 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 INFORMATION." }, { "mdr_text_key": "325531576", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE-PORT (SP) PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE SURGEON WAS USING A GELPORT + AIR SEAL WITH THE DA VINCI SP SYSTEM, AND THEY EXPERIENCED A COMPLICATION WHERE AIR TRAVELED UP THE PATIENT'S BODY CAVITY, RESULTING IN A PNEUMOTHORAX. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND THEIR ASSOCIATE FOR ADDITIONAL INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN PROVIDED." } ], "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": "11/09/2023;12/06/2023" } ] }