{ "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": "N", "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": "2955842-2008-01195", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080808", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20080429", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "INVALID DATA", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20080819", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080808", "brand_name": "DA VINCI S 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": "US", "manufacturer_d_postal_code": "*", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P4", "catalog_number": "*", "lot_number": "*", "other_id_number": "*", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": [ "Unknown (for use when the device problem is not known)" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20080808", "sequence_number_treatment": [ "ACCESSORIES", " DA VINCI S SURGICAL SYSTEM INSTRUMENTS" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "*", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Low Blood Pressure/ Hypotension", "Hypovolemic Shock", "Pneumothorax", "Tachycardia", "Perforation of Vessels", "Transfusion of blood products", "Therapy/non-surgical treatment, additional", "Therapy/non-surgical treatment/delayed/prolonged", "Surgical procedure, additional", "Hospitalization required", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20080808", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1118753", "removal_correction_number": "", "number_devices_in_event": "", "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": "892551", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 7/11/08, ISI RECEIVED MEDWATCH REPORT, WHICH INDICATES THAT AN ADVERSE EVENT OCCURRED IN '08, DURING THE USE OF THE DA VINCI S SURGICAL SYSTEM AND A GYNECARE X-TRACT TISSUE MORCELLATOR IN A SURGICAL PROCEDURE. THE REPORT WAS SUBMITTED TO THE FDA BY THE PT, HOWEVER, A DESCRIPTION OF THE EVENT WAS NOT PROVIDED." }, { "mdr_text_key": "8106487", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 7/30/08, ADDITIONAL INFO REGARDING THE EVENT WAS PROVIDED BY THE PT'S SIBLING. IT WAS REPORTED THAT AT THE END OF THE DA VINCI S HYSTERECTOMY SURGICAL PROCEDURE, THE SURGICAL STAFF INSERTED A GYNECARE X-TRACT MORCELLATOR INTO THE PT, HOWEVER, IT WAS NOT SECURELY ATTACHED. WHEN THE SURGEON TRIED TO ATTACH THE MORCELLATOR INTRAABDOMINALLY, THE SURGEON LOST CONTROL OF THE MORCELLATOR AND INJURED THE PT'S AORTA, INFERIOR VENA CAVA AND COMMON ILIAC ARTERY (CIA). AS A RESULT, THE PT NEEDED A VEIN GRAFT FOR THE CIA REPAIR. ON 8/7/08, ADDITIONAL INFO WAS PROVIDED BY AN ISI REP WHO REPORTED THAT DURING THE TIME OF THE EVENT, A SYSTEM ARM WAS UNDOCKED IN ORDER FOR THE SURGICAL STAFF TO INSERT THE MORCELLATOR THROUGH THAT PORT SITE AND ONLY THE SYSTEM CAMERA WAS BEING USED WHEN THE INJURY OCCURRED. BASED ON THE INFO PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM DID NOT MALFUNCTION IN A WAY THAT WOULD CAUSE NOR CONTRIBUTE TO THE PT INJURY." } ], "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": "" } ] }