{ "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": "", "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": "2955842-2013-01151", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130405", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130302", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20130412", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "139796", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130405", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, NAY", "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": "US", "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": "DA", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "MS", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20130405", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20130306", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3052979", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130306", "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": "3365668", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER A DA VINCI ST BENIGN HYSTERECTOMY PROCEDURE WAS PERFORMED, THE PATIENT CAME BACK TO THE HOSPITAL WITH POST-OPERATIVE SYMPTOMS OF PRESSURE AND BLOATING. THE SURGEON OPENED THE PATIENT AND REPORTEDLY NOTICED A SMALL BOWEL INJURY. THE SURGEON PROCEEDED TO PERFORM A BOWEL RESECTION PROCEDURE. DURING THE BOWEL RESECTION PROCEDURE, THE PATIENT WAS PLACED ON A VENTILATOR. THE PATIENT REPORTEDLY ALMOST PASSED AWAY DURING THE BOWEL RESECTION PROCEDURE FOR AN UNKNOWN REASON. AT THE TIME THE INITIAL REPORTER REPORTED THE EVENT TO INTUITIVE SURGICAL INC. (ISI), THE PATIENT WAS IN THE ICU AND WAS DOING WELL." }, { "mdr_text_key": "10627016", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "CONCLUSIONS - ON (B)(4) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) ASSIGNED TO THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR INDICATED THAT THE DA VINCI SI BENIGN HYSTERECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2013 AND LASTED APPROXIMATELY 30 MINUTES. THE CSR INDICATED THAT THE SURGICAL PROCEDURE WENT SMOOTHLY WITHOUT ANY PATIENT COMPLICATIONS REPORTED. ON (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL WITH SYMPTOMS OF PRESSURE AND BLOATING. A CT SCAN WITH CONTRAST WAS PERFORMED AND A PERFORATION OF THE BOWEL WAS FOUND. THE SURGEON PERFORMED AS BOWEL RESECTION VIA OPEN SURGERY TO REPAIR THE BOWEL INJURY. ACCORDING TO THE CSR, THE PATIENT DID NOT DO WELL THE FIRST NIGHT POST-OP AND WAS PUT ON A VENTILATOR. BY THE SECOND DAY POST-OP, THE PATIENT WAS DOING WELL. THE PATIENT WAS REPORTEDLY IN THE ICU FOR TWO WEEKS BEFORE BEING DISCHARGED FROM THE HOSPITAL. THE CSR INDICATED THAT THE GENERAL SURGEON AT THE SITE DETERMINED THAT THE BOWEL INJURY WAS DUE TO CANNULA ENTRY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED OR CONTRIBUTED TO THE PATIENT'S INJURY." } ], "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": "" } ] }