{ "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": "2955842-2013-01866", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130529", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130404", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "RISK MANAGER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130529", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "234492", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130529", "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 A6.0P7", "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": "CO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20130529", "sequence_number_treatment": [ "DA VINCI SI SURG SYS, INSTRUMENTS, ACCSS & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "38 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pain", "Abnormal Vaginal Discharge", "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20130429", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3133714", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130429", "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": "10847470", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013 INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT PATIENT UNDERWENT A DA VINCI URETERAL RE-IMPLANTATION PROCEDURE TO REPAIR THE DAMAGE TO THE PATIENT'S URETER. PER THE INITIAL REPORTER, NO VIDEO RECORDING OF THE PROCEDURE IS AVAILABLE. THE INITIAL REPORTER INDICATED THAT THERE WAS NO REPORT BY THE SURGICAL STAFF THAT A MALFUNCTION OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT OCCURRED DURING THE SURGICAL PROCEDURE AND NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OR ACCESSORIES OCCURRED. THE HOSPITAL'S INVESTIGATION INTO THE REPORTED EVENT DID NOT DETERMINE THE ROOT CAUSE OF THE INJURY TO THE PATIENT AND IT WAS UNKNOWN IF THE INJURY SUSTAINED BY THE PATIENT OCCURRED AS A RESULT OF A USER ERROR OR AS A RESULT OF A MALFUNCTION OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT THAT WAS NOT NOTED DURING THE SURGICAL PROCEDURE. THE SURGEON AND SURGICAL STAFF INSPECTED THE INSTRUMENT FOR DAMAGE AND SINCE NO DAMAGE TO THE INSTRUMENT WAS FOUND THE INSTRUMENT WAS PLACED BACK INTO CIRCULATION. THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT WILL NOT BE RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE FOUND NO SYSTEM ERRORS WERE GENERATED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO INJURY SUSTAINED BY THE PATIENT." }, { "mdr_text_key": "3490604", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, ISI RECEIVED MEDWATCH REPORT NUMBER HCA (B)(4). THE EVENT DETAILS ARE PROVIDED BELOW: ROBOTIC-ASSISTED TOTAL HYSTERECTOMY, CYSTOSCOPY AND VENTRAL HERNIA REPAIR ON (B)(6) 2013. DURING THIS SURGERY AN (B)(6) UTERUS WITH MULTIPLE FIBROIDS WERE REMOVED. THE UTERUS WAS NOTED TO BE MARKEDLY ENLARGED AND IRREGULARLY SHAPED DUE TO THE MULTIPLE FIBROIDS. PATIENT DEVELOPED MULTIPLE BACK BLEEDERS AND THESE WERE CAUTERIZED WITH BIPOLAR CAUTERY. DUE TO THE \"GINORMOUS\" SIZE OF THE UTERUS, IT DID NEED TO BE MORCELLATED. INDIGO CARMAINE WAS GIVEN IV AND THE CYSTOSCOPY WAS PERFORMED; 70 DEGREE SCOPE WAS USED AND BOTH URETERAL JETS WERE EASILY VISUALIZED AND RELEASED INDIGO CARMINE. AT THE COMPLETION OF THIS PROCEDURE, THERE WAS NO FREE FLOW FROM VAGINA. FIVE DAYS POST OP ((B)(6) 2013) THE PATIENT DEVELOPED SEVERE PAIN AND CLEAR DISCHARGE FROM VAGINA. PATIENT RETURNED TO THE OPERATING ROOM AND IT WAS DISCOVERED THE PATIENT HAD SUSTAINED A THERMAL INJURY TO HER R URETER. A STENT WAS ATTEMPTED BUT UNABLE TO PASS THROUGH AREA OF INJURY. A PERCUTANEOUS NEPHROSTOMY TUBE DRAIN WAS THEN USED. ON (B)(6) 2013 SUCCESSFUL URETERAL RE-IMPLANTATION OCCURRED." } ], "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": "" } ] }