{ "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": "I", "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": "Injury", "report_number": "2955842-2018-10785", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20181227", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20181129", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20181227", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1040310", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181227", "brand_name": "DA VINCI XI SURGICAL SYSTEM", "generic_name": "DA VINCI XI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS4001-01", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/07/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20181227", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20181221", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8201378", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20181221", "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": "282089748", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 01/07/2019, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SITE¿S ROBOTICS COORDINATOR: THE SITE DOES NOT BELIEVE THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE COMPLICATION. PER THE ROBOTICS COORDINATOR, THE SURGICAL FIELD/SITE WAS DIFFICULT TO SEE AND DURING THE COURSE OF MORCELLATION THROUGH A LARGE TROCAR, AN \"INCREASED VENOUS ACCUMULATION OF BLOOD IN THE SMALL PELVIS\" OCCURRED. ACCORDING TO THE ROBOTICS COORDINATOR, DURING THE MORCELLATION PROCESS OF THE LARGE UTERUS, IT IS PRESUMED THAT AN EXTERNAL ILIAC VEIN WAS INJURED ALTHOUGH THE ACTUAL SOURCE OF THE BLEEDING IS UNKNOWN. A BLOOD TRANSFUSION WAS ADMINISTERED AND THE LEFT EXTERNAL ILIAC VEIN WAS LIGATED. BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE ROBOTICS COORDINATOR, THIS COMPLAINT IS NO LONGER DEEMED REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE SITE DOES NOT BELIEVE A DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT¿S INTRA-OPERATIVE COMPLICATION. THE SITE BELIEVES THE VESSEL INJURY OCCURRED DURING THE MORCELLATION PROCESS WHICH INVOLVES THE USE OF A MORCELLATOR INSTRUMENT (A NON-DA VINCI PRODUCT)." }, { "mdr_text_key": "131585627", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2018. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AT THE COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, ¿ENDOSCOPICALLY INVISIBLE, SILENT BLEEDING¿ WAS IDENTIFIED AND THE CASE WAS CONVERTED TO OPEN SURGERY. AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "131585628", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, A CABLE ON A FENESTRATED BIPOLAR FORCEPS INSTRUMENT ALLEGEDLY ¿RUPTURED.¿ THERE WAS NO REPORTED HARM TO THE PATIENT ALTHOUGH IT WAS NOTED THAT THE CASE WAS CONVERTED TO OPEN SURGERY. THE INITIAL REPORTER INDICATED, HOWEVER, THAT THE CONVERSION TO OPEN SURGERY WAS NOT DUE TO THE ALLEGED INSTRUMENT ISSUE. ON (B)(4) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE¿S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: AFTER THE DA VINCI-ASSISTED HYSTERECTOMY WAS COMPLETED, IT WAS ALLEGED THAT ¿ENDOSCOPICALLY INVISIBLE, SILENT BLEEDING¿ OCCURRED. AS A RESULT, THE CASE WAS CONVERTED TO OPEN SURGERY. THE ROBOTICS COORDINATOR INDICATED THAT THE PATIENT WAS ¿FINE¿ AND THERE HAVE BEEN NO REPORTED POST-OPERATIVE COMPLICATIONS. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN." } ], "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": "01/10/2019" } ] }