{ "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": "2955842-2012-00690", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20121027", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120918", "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": "20121031", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121027", "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": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20121027", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Hernia", "Abdominal Distention" ] } ], "distributor_city": "", "date_report": "20120927", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2807212", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120927", "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": "2948119", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT 4 DAYS AFTER A DA VINCI SI HYSTERECTOMY SURGERY THE PATIENT PRESENTED A DISTENDED ABDOMEN AND COMPLAINED OF PAIN. IMAGING WAS PERFORMED AND THE SURGICAL STAFF CONCLUDED THE PATIENT HAD A SBO (SMALL BOWEL OBSTRUCTION) AND A PORT SITE HERNIA. THE PATIENT HAD A LAPAROTOMY AND SMALL BOWEL RESECTION 1 WEEK AFTER THE ORIGINAL SURGERY AND WAS IN THE HOSPITAL 2-3 WEEKS AFTER THAT. ON (B)(6) 2012 THE SURGEON CONFIRMED THAT PATIENT IS AT HOME AND DOING WELL CURRENTLY. THIS INVESTIGATION IS STILL ONGOING AND A FOLLOW-UP MDR WILL BE GENERATED IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "10435093", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION AND THE INVESTIGATION IS STILL PENDING. TO DATE NO ALLEGATION OF DEFICIENCY OF DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES HAS BEEN MADE. ADDITIONAL ATTEMPTS ARE BEING MADE TO FOLLOW-UP WITH THE PHYSICIAN TO DETERMINE THE CAUSE OF THE SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED. THE ROOT CAUSE OF THE SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT IS ALSO CURRENTLY UNDETERMINED. ON (B)(6) 2012, THE SURGEON INDICATED THAT THE PATIENT IS AT HOME NOW AND IS DOING WELL." } ], "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": "" } ] }