{ "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": "2955842-2013-02487", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130710", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130604", "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", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130710", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "318444", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130710", "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 A6.0P5", "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": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20130710", "sequence_number_treatment": [ "DA VINCI SI SYS. , INSTRUMENTS, ACCESSORIES & ES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "86", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20130610", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3215389", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130610", "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": "3652500", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT 2 DAYS POST OP A SUCCESSFUL DA VINCI SI LEFT SALPINGO-OOPHORECTOMY PROCEDURE, PERFORMED ON (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM ON (B)(6) 2013 WITH SYMPTOMS OF ABDOMINAL PAIN. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND IT WAS DISCOVERED THAT THE PATIENT HAD FREE AIR IN HER ABDOMEN AND HER SIGMOID COLON WAS DAMAGED AT THE SITE OF DISSECTION DURING THE INITIAL SURGICAL PROCEDURE." }, { "mdr_text_key": "11028940", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL FOR ADDITIONAL INFORMATION. THE SURGEON INDICATED THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT DURING THE DA VINCI LEFT SALPINGO-OOPHORECTOMY PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 AND PRIOR TO THE PATIENT'S RELEASE FROM THE HOSPITAL THE PATIENT HAD NOT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS. THE SURGEON INDICATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THAT IT WAS HER BELIEF THAT PATIENT'S INJURY WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES, BUT RATHER DUE TO DENSE PELVIC ADHESIONS. DURING THE (B)(6) 2013 SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S OVARY WAS STUCK TO HER LEFT SIGMOID COLON. THE SURGEON INDICATED THAT THE DAMAGE TO THE PATIENT'S SIGMOID COLON WAS A TINY PERFORATION THAT LIKELY OCCURRED WHILE TAKING DOWN THE PATIENT'S ADHESIONS AND OVARY. THE SURGEON STATED THAT IT WAS HER BELIEF THAT THE DUE TO THE PATIENT'S EXTENSIVE ADHESIONS, THE INJURY SUSTAINED BY THE PATIENT, MAY HAVE OCCURRED IF SHE HAD PERFORMED THE SURGICAL PROCEDURE USING TRADITIONAL LAPAROSCOPIC TECHNIQUES OR TRADITIONAL OPEN SURGICAL TECHNIQUES. A PARTIAL SIGMOID RESECTION WITH PRIMARY RE-ANASTOMOSIS WAS PERFORMED TO REPAIR THE DAMAGE TO THE PATIENT'S SIGMOID COLON. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 AND IS RECOVERING SLOWLY. ISI REVIEWED THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE. NO SYSTEM ERROR CODES 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": "" } ] }