{ "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": "HOSPITAL", "report_to_fda": "", "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": "Death", "report_number": "2955842-2012-00198", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20120508", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100224", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120508", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120508", "brand_name": "DA VINCI SI 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": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A60.P6", "catalog_number": "", "lot_number": "", "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": [ "Migration or Expulsion of Device", "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20120508", "sequence_number_treatment": [ "DA VINCI SI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding", "Laceration(s)", "Great Vessel Perforation" ] } ], "distributor_city": "", "date_report": "20120405", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2563461", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120405", "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": "2750185", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, INTUITIVE SURGICAL RECEIVED A LEGAL SUMMONS INDICATING THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, WHILE THE SURGEON WAS PERFORMING NODE DISSECTION, THE SURGEON CUT THE PATIENT'S ILIAC ARTERY AND VEIN CAUSING BLEEDING FROM THOSE VESSELS. A HEMO-CLIP WAS APPLIED TO THE AFFECTED AREA, HOWEVER, THE CLIP TORE THROUGH THE AREA WHERE THE CLIP WAS APPLIED CAUSING SIGNIFICANT HEMORRHAGE FROM THE PELVIC VESSELS. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN LAPAROTOMY TECHNIQUES. THE PATIENT EXPIRED ON (B)(6) 2012." }, { "mdr_text_key": "9847573", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2012, ISI CONTACTED (B)(6) IN RISK MANAGEMENT AT (B)(6) TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT, HOWEVER, SHE DECLINED TO PROVIDE ANY INFORMATION CONCERNING THE REPORTED EVENT DUE TO LITIGATION CONSTRAINTS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA." }, { "mdr_text_key": "10859962", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "CORRECTION: THE DA VINCI SI HYSTERECTOMY PROCEDURE WAS ON (B)(6) 2010 AND NOT (B)(6) 2012 AS INITIALLY INDICATED THE INITIAL REPORT THAT WAS SUBMITTED TO THE FDA (B)(4) 2012." }, { "mdr_text_key": "21150165", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A REVIEW OF THE SITE'S SYSTEM LOG FOUND NO ERRORS FOR SURGERIES PERFORMED ON THE DATE OF THE REPORTED EVENT ((B)(6) 2010)." } ], "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": "06/06/2012;06/27/2013" } ] }