{ "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": "2955842-2014-02884", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140508", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140124", "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": "20140509", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "279482", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140508", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20140508", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "45 YR", "patient_sex": "", "patient_weight": "79", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20140124", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3801237", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140124", "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": "4479359", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, WHILE THE SURGEON WAS UTILIZING A MONOPOLAR CURVED SCISSORS INSTRUMENT AND A FENESTRATED BIPOLAR FORCEPS INSTRUMENT, THE PATIENT SUSTAINED A THERMAL INJURY TO HER RECTUM. THE SURGEON CONSULTED A GENERAL SURGEON TO EVALUATE THE DEFECT. AFTER EXAMINING THE PATIENT'S RECTUM, THE GENERAL SURGEON DETERMINED THAT THE AFFECTED AREA DID NOT REQUIRE ANY TREATMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. APPROXIMATELY 5 DAYS POST-OP AND DURING THE PATIENT'S HOSPITALIZATION, THE PATIENT COMPLAINED OF PAIN. EXAMINATION OF THE PATIENT FOUND THAT THE PATIENT HAD DEVELOPED A RECTAL CERVICAL FISTULA. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION FROM THE SURGEON WHO PERFORMED THE DA VINCI HYSTERECTOMY PROCEDURE. ACCORDING TO THE SURGEON THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE DUE TO FIBROIDS, MENORRHAGIA AND ANEMIA. THE PATIENT'S UTERUS WEIGHED 615 GRAMS AND WAS 20 WEEKS IN SIZE. THE SURGEON INDICATED THAT AFTER THE PATIENT'S UTERUS HAD BEEN MORCELLATED AND REMOVED, HE IDENTIFIED A WHITE SPOT ON THE PATIENT'S SIGMOID COLON THAT WAS CLOSE TO THE UTERINE CERVIX JUNCTION. WHILE THE GENERAL SURGEON CONFIRMED THAT NO REPAIR OF THE PATIENT'S SIGMOID COLON WAS REQUIRED, AS A PRECAUTION, THE SURGEON MADE THE DECISION TO HAVE THE PATIENT HOSPITALIZED FOR AN ADDITIONAL 3 DAYS. ACCORDING TO THE SURGEON, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. IT IS THE SURGEON'S BELIEF THAT THE INJURY TO THE PATIENT'S SIGMOID COLON WAS UNRELATED TO A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE INJURY TO THE PATIENT OCCURRED IN PART DUE TO THE PATIENT'S DIFFICULT ANATOMY AND THERMAL SPREAD FROM THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT DURING DISSECTION. THE PATIENT HAD WIDE EXTENDED FIBROIDS WITH A VERY THICKENED PARAMETRIUM. ONE OF THE FIBROIDS HAD EXTENDED TO THE PARARECTAL RETROPERITONEAL AREA AND HER SIGMOID COLON HAD CHANGED FROM THE REGULAR COURSE, AS IT WAS OBSERVED THAT HER SIGMOID COLON HAD SHIFTED TO THE RIGHT SIDE. THE PATIENT ALSO HAD ADHESIONS CLOSE TO THE UTERO CERVICAL JUNCTION AREA. THE SURGEON INDICATED THAT THE PATIENT UNDERWENT AN OPEN LOW ANTERIOR RESECTION WITH COLOSTOMY PROCEDURE TO REPAIR THE DAMAGE TO HER SIGMOID COLON. THE PATIENT RECOVERED WELL FROM THE OPEN SURGICAL PROCEDURE. THE PATIENT WILL UNDERGO A 3RD SURGICAL PROCEDURE AT AN UNSPECIFIED DATE TO REVERSE HER COLOSTOMY." }, { "mdr_text_key": "11732386", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, IT HAS BEEN DETERMINED THAT THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DID NOT CAUSE OR CONTRIBUTE TO THE THERMAL INJURY THAT THE PATIENT SUSTAINED DURING HER DA VINCI HYSTERECTOMY PROCEDURE. PER THE INFORMATION PROVIDED BY THE SURGEON, THE COLON INJURY SUSTAINED BY THE PATIENT OCCURRED IN PART DUE TO THE PATIENT'S DIFFICULT ANATOMY AND THERMAL SPREAD FROM THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT DURING DISSECTION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT SUSTAINED A THERMAL INJURY TO HER SIGMOID COLON. THE PATIENT DEVELOPED A RECTAL CERVICAL FISTULA POST OP, WHICH REQUIRED THE PATIENT TO UNDERGO A LOW ANTERIOR RESECTION WITH COLOSTOMY 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." } ], "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": "" } ] }