{ "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": "2955842-2013-03557", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130913", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130815", "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": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130916", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "463012", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130913", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20130913", "sequence_number_treatment": [ "DA VINCI SI SURG SYS, INSTRUMENTS, ACCESS & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss" ] } ], "distributor_city": "", "date_report": "20130815", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3348117", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130815", "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": "3865496", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI LOW ANTERIOR RESECTION PROCEDURE, WHILE THE SURGEON WAS PERFORMING DISSECTION AND MOBILIZING, THE PATIENT'S ILIAC VESSEL WAS NICKED, CAUSING THE PATIENT TO LOSE BLOOD. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES TO CONTROL THE PATIENT'S BLEEDING. REPORTEDLY, NO MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "11095617", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE WHO WAS ON-SITE WHEN THE REPORTED EVENT OCCURRED. THE CSR INDICATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE; HOWEVER, HE WAS NOT PRESENT WHEN THE INCIDENT OCCURRED. PER THE CSR, HE STEPPED OUT OF THE OPERATING ROOM AND WHEN HE RETURNED THE SURGEON WAS CONVERTING THE PROCEDURE TO OPEN SURGICAL TECHNIQUES. ACCORDING TO THE CSR, HE DISCUSSED THE INJURY WITH THE SURGEON AND HE WAS TOLD BY THE SURGEON THAT HE INADVERTENTLY NICKED THE PATIENT'S INFERIOR MESENTERIC ARTERY (IMA). AS A RESULT, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES TO CONTROL THE BLEEDING, REPAIR AND COMPLETE THE SURGICAL PROCEDURE. REPORTEDLY, THE CSR WAS TOLD BY THE SURGEON THAT THE CASE WAS DIFFICULT DUE TO THE PATIENT'S ANATOMY AND THAT DAMAGE TO THE PATIENT'S IMA MAY HAVE LIKELY OCCURRED REGARDLESS OF THE SURGICAL MODALITY USED. REPORTEDLY, NO MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. THIS COMPLAINT IS BEING REPORTED DUE TO AN INJURY SUSTAINED BY THE PATIENT DURING A DA VINCI SI LOW ANTERIOR RESECTION PROCEDURE. 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. BASED ON THE INFORMATION PROVIDED, IT HAS BEEN DETERMINED THAT THE INJURY TO THE PATIENT'S IMA WAS NOT CAUSED BY A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES; BUT RATHER OCCURRED WHEN THE SURGEON INADVERTENTLY NICKED THE PATIENT'S VESSEL." } ], "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": "" } ] }