{ "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": "2955842-2014-01374", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140307", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140206", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140307", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "139665", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140307", "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": "NC", "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": "20140307", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Injury" ] } ], "distributor_city": "", "date_report": "20140210", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3666909", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140210", "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": "11581277", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S INTRA-OPERATIVE COMPLICATION. THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE IS ALSO NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A URETERAL INJURY THAT WAS REPAIRED INTRA-OPERATIVELY DURING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "4339689", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY WITH BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY PROCEDURE FOR ENDOMETRIAL CANCER STAGING, THE PATIENT SUSTAINED A URETERAL INJURY. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CLINICAL FELLOW, THE DA VINCI FLUORESCENCE IMAGING VISION SYSTEM WAS BEING USED DURING AN INSTITUTIONAL REVIEW BOARD (IRB) APPROVED RESEARCH PROTOCOL IN WHICH A PATIENT RECEIVED A CERVICAL INTERSTITIAL INJECTION OF INDOCYANINE GREEN (ICG) FOR THE PURPOSE OF SENTINEL LYMPH NODE MAPPING. DURING DISSECTION OF A SENTINEL LYMPH NODE FROM THE LEFT PARA-AORTIC LYMPH NODE CHAIN AND WHILE THE SURGEON WAS OPERATING IN THE FLUORESCENCE IMAGING MODE, A 2MM THERMAL INJURY TO THE LEFT URETER AT THE LEVEL OF THE INFERIOR MESENTERIC ARTERY OCCURRED. THE CLINICAL FELLOW INDICATED THAT THE INJURY OCCURRED BECAUSE VISUALIZATION WAS POOR DUE TO BLEEDING (CONTAMINATING THE SURGICAL FIELD) AND BECAUSE THE LEFT URETER, WHICH HAD ORIGINALLY BEEN IDENTIFIED AND RETRACTED BY THE 3RD ARM, SLIPPED OUT FROM ITS RETRACTION INTO THE SURGICAL FIELD. AT THE TIME THE INJURY OCCURRED, LEAKAGE OF URINE WAS VISIBLE AND IDENTIFIED INTRAOPERATIVELY. SHE ALSO INDICATED THAT THE INJURY LIKELY OCCURRED WHEN BLEEDING WAS ENCOUNTERED DURING RETRIEVAL OF THE LYMPH NODE, CAUSING POOR VISIBILITY IN THE FIELD AND INADVERTENT THERMAL INJURY TO THE URETER DURING ATTEMPTS TO CONTROL THIS BLEEDING. THE URETER WAS STENTED TO FACILITATE HEALING AND OVERSEWN AT THE POINT OF THE URETEROTOMY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT'S LENGTH OF STAY WAS NOT INCREASED DUE TO THE REPORTED EVENT." } ], "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": "" } ] }