{ "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": "Death", "report_number": "2955842-2012-00326", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20120713", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120608", "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": "20120713", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120713", "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 A6.0P7", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20120713", "sequence_number_treatment": [ "DA VINCI SI SURGICAL SYSTEM INSTS. & ACCS., ESU" ], "sequence_number_outcome": [ "Death" ], "patient_age": "72 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20120614", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2655010", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120614", "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": "2820065", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT A HEMICOLECTOMY PROCEDURE ON (B)(6) 2012 IN WHICH TRADITIONAL LAPAROSCOPIC TECHNIQUES AND THE DA VINCI SI SYSTEM WERE USED. AN UNRECOGNIZED BOWEL PERFORATION OCCURRED WHILE PERFORMING TRADITIONAL LAPAROSCOPIC TECHNIQUES DURING ADHESIOLYSIS. THE PATIENT EXPIRED ON (B)(6) 2012." }, { "mdr_text_key": "10021318", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2012, INTUITIVE SURGICAL'S CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE SURGEON AND THE SURGEON INDICATED THAT IT WAS HIS INTENT TO PERFORM THE PLANNED SURGICAL PROCEDURE USING TRADITIONAL LAPAROSCOPIC TECHNIQUES AND THE DA VINCI SI SURGICAL SYSTEM. PER THE CSR, THE SURGEON INDICATED THAT THE PATIENT'S ADHESIONS WERE DISSECTED USING TRADITIONAL LAPAROSCOPIC SURGICAL TECHNIQUES AND THAT THE DA VINCI SI SYSTEM WAS NOT DOCKED TO THE PATIENT DURING ADHESIOLYSIS. PER THE CSR, THE SURGEON BELIEVES THAT DAMAGE TO THE PATIENT'S BOWEL WAS INTRODUCED WHILE PERFORMING ADHESIOLYSIS DURING THE TRADITIONAL LAPAROSCOPIC PORTION OF THE SURGICAL PROCEDURE. THE SURGEON INDICATED TO ISI'S CSR THAT THE PLANNED SURGICAL WAS COMPLETED WITH THE DA VINCI SI SURGICAL SYSTEM AND THAT NO MALFUNCTION OF THE DA VINCI SI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED. NO OTHER INFORMATION CONCERNING THE REPORTED EVENT WAS PROVIDED." } ], "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": "" } ] }