{ "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": "2955842-2014-03961", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140627", "manufacturer_address_2": "", "pma_pmn_number": "", "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": [ "Foreign", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140630", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "377710", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140627", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC ELECTROSURGICAL 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": "LAY USER/PATIENT", "model_number": "", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20140627", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Injury" ] } ], "distributor_city": "", "date_report": "20140529", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3900685", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140529", "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": "16302830", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A JOURNAL ARTICLE TITLED, COMPLETELY ABDOMINAL INTERSPHINCTERIC RESECTION FOR LOWER RECTAL CANCER: FEASIBILITY AND COMPARISON OF ROBOT-ASSISTED AND OPEN SURGERY. THIS ARTICLE IS FROM ENDOSCOPY SURGICAL AND OTHER INTERVENTIONAL TECHNIQUES. ARTICLE WAS PUBLISHED ON 02 APRIL 2014. ACCORDING TO THE REPORTED ARTICLE, FIVE PATIENTS AND ONE PATIENT, RESPECTIVELY, IN THE OPEN AND THE RA GROUP WITH PRESACRAL BLEEDING, AND ONE INADVERTENT INJURY AT THE DISTAL RECTUM DURING ISR IN THE RA GROUP. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENTS. THE DA VINCI SYSTEM SERIAL NUMBER INVOLVED WITH EACH SURGICAL PROCEDURE WAS NOT INCLUDED IN THIS ARTICLE." }, { "mdr_text_key": "16313008", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE PRESACRAL BLEEDING OR THE INJURY AT THE DISTAL RECTUM DURING INTERSPHINCTERIC RESECTION (ISR). IN THE ARTICLE, THERE WERE NO PROCEDURE DATES, HOSPITAL NAME(S) OR SURGEON NAME(S) PROVIDED. THE JOURNAL ARTICLE DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED DURING THE REPORTED PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE PRIMARY REPORTER TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENTS; 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE JOURNAL ARTICLE INDICATED THAT DURING A DA VINCI PROCEDURES, TWO PATIENTS EXPERIENCED INTRAOPERATIVE COMPLICATIONS." } ], "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": "" } ] }