{ "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": "2955842-2010-00319", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20100716", "manufacturer_address_2": "", "pma_pmn_number": "K063220", "date_of_event": "20100617", "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": "20100719", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100716", "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": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P8", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "HI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20100716", "sequence_number_treatment": [ "DA VINCI S SYS, INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20100621", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1760065", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20100621", "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": "1563580", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE PATIENT EXPERIENCED A HIGHER THAN NORMAL BLOOD LOSS REQUIRING A BLOOD TRANSFUSION. THE PATIENT WAS REPORTED AS BEING STABLE WHEN THE SURGICAL STAFF MADE THE DECISION TO CONTINUE WITH THE PROCEDURE WITHOUT INCIDENT. ONE DAY POST OPERATION, THE PATIENT WAS OBSERVED TO HAVE INTERNAL BLEEDING AND WAS BROUGHT IN THE OPERATING ROOM WHERE IT WAS DETERMINED THAT HER ILIAC ARTERY HAD BEEN NICKED. THE SURGICAL STAFF CONTROLLED THE BLEEDING BY PACKING THE AFFECTED AREA AND KEEPING THE PATIENT OVER THE WEEKEND. TWO DAYS LATER THE BLEEDING WAS FOUND TO BE UNDER CONTROL AND THE PACKING WAS REMOVED. NO ADDITIONAL PATIENT INJURY OR ADVERSE EVENT HAS BEEN REPORTED. THE SURGEON HAS REPORTED THAT THE PATIENT IS DOING WELL WITH NO FURTHER ISSUES." }, { "mdr_text_key": "8613891", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM DID NOT MALFUNCTION IN A WAY THAT WOULD CAUSE NOR CONTRIBUTE TO THE PATIENT INJURY. IT IS UNDETERMINED IF USE ERROR WAS A CONTRIBUTING FACTOR TO THIS EVENT AS PER THE SURGEON, IT IS POSSIBLE THAT HE UNKNOWINGLY NICKED THE PATIENT'S ILLIAC ARTERY DURING THE PROCEDURE. ON (B)(6) 2010, THE SURGEON REPORTED THAT THE PATIENT IS RECOVERING WELL WITH NO FURTHER COMPLICATIONS. AS OF JULY 16, 2010, NO ADVERSE EVENTS OR SYSTEM MALFUNCTIONS HAVE BEEN EXPERIENCED WITH THE SITE'S DA VINCI S SURGICAL SYSTEM." } ], "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": "" } ] }