{ "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": "Injury", "report_number": "2955842-2014-03148", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140522", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140422", "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": "20140522", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "305945", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140522", "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 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20140522", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Complaint, Ill-Defined", "Loss of consciousness" ] } ], "distributor_city": "", "date_report": "20140423", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3826496", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140423", "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": "4497564", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT 4 HOURS POST A DA VINCI SINGLE SITE HYSTERECTOMY PROCEDURE, THE PATIENT REPORTED THAT SHE WAS NOT FEELING WELL AND PASSED OUT. A CT SCAN PERFORMED ON THE PATIENT SHOWED BLOOD IN HER ABDOMEN. THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND IT WAS DISCOVERED THAT THE PATIENT WAS BLEEDING FROM HER LEFT UTERINE ARTERY. REPORTEDLY, THE PATIENT'S BLEEDING WAS CONTROLLED AND THE PATIENT IS RECOVERING FINE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR HE WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE AND THAT DURING THE SURGICAL PROCEDURE, HE DID NOT OBSERVE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE CSR INDICATED THAT TOWARDS THE END OF THE SURGICAL PROCEDURE, WHILE THE SURGEON WAS CLOSING THE PATIENT'S VAGINAL CUFF, INSUFFLATION WAS LOST. AT THAT TIME THE SURGEON MADE THE DECISION TO COMPLETE THE CLOSURE OF THE PATIENT'S VAGINAL CUFF VAGINALLY. THE LOSS OF INSUFFLATION WAS RELATED TO A THIRD PARTY DEVICE AND NOT TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. AT THE END OF THE PROCEDURE, THE SURGICAL AREA WAS FOUND TO BE HEMOSTATIC AND THERE WAS NO ACTIVE BLEEDING NOTED AT THE END OF THE SURGERY. ACCORDING TO THE CSR, HE WAS TOLD BY THE ATTENDING RESIDENT AT THE HOSPITAL THAT WHILE THE PATIENT WAS IN THE RECOVERY ROOM, HER VESSEL BLEW. THE PATIENT'S VESSEL WAS REPAIRED USING TRADITIONAL LAPAROSCOPIC TECHNIQUES." }, { "mdr_text_key": "11867655", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE DAMAGE TO THE PATIENT'S UTERINE ARTERY HAS NOT BEEN DETERMINED. ISI HAS CONTACTED THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED BLEEDING FROM HER UTERINE ARTERY POST A DA VINCI SINGLE SITE HYSTERECTOMY PROCEDURE. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURY 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": "" } ] }