{ "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": "I", "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": "2955842-2018-10014", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20180223", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20180124", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20180223", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "136280", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180223", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000", "catalog_number": "", "lot_number": "N/A", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20180223", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " O", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Perforation", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20180131", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7292981", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20180131", "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": "100832420", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, IT IS INDETERMINABLE AS TO WHAT CAUSED OR CONTRIBUTED TO THE BOWEL INJURY SUSTAINED BY THE PATIENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI SURGICAL PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS THAT REQUIRED THE PATIENT TO UNDERGO A SECONDARY SURGICAL PROCEDURE FOR EXPLORATION AND SUBSEQUENT REPAIR OF A BOWEL PERFORATION. IT IS UNKNOWN WHAT CAUSED THE PERFORATION TO THE PATIENT'S BOWEL. THERE WAS NO REPORT OF ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES, AND IT WAS NOT REPORTED THAT THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES CAUSED THE PATIENT ¿S INJURY." }, { "mdr_text_key": "100832421", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT TWO DAYS POST A DA VINCI ASSISTED RIGHT HEMICOLECTOMY PROCEDURE THE PATIENT EXPERIENCE COMPLICATIONS AND VITAL SIGNS WERE FOUND TO BE POOR. THE PATIENT UNDERWENT A SECONDARY OPEN SURGICAL PROCEDURE AT WHICH TIME THE SURGEON DISCOVERED THAT THE PATIENT HAD SUSTAINED AN UNSPECIFIED BOWEL INJURY. THE SURGEON REPAIRED THE DAMAGE TO THE PATIENT¿S BOWEL. ON (B)(6) 2018 THE ISI CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT THE PATIENT UNDERWENT THE PRIMARY SURGICAL PROCEDURE ON (B)(6) 2018 AND DURING THE SURGICAL PROCEDURE, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. ON POST-OPERATIVE DAY #2, THE PATIENT EXPERIENCED A HIGH FEVER, HAD LOW BLOOD PRESSURE, AND THE VITAL SIGNS WERE FOUND TO BE POOR. THE PATIENT WAS IMMEDIATELY FLOWN TO ANOTHER HOSPITAL WHERE THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE TO IDENTIFY THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS. DURING THE SECONDARY PROCEDURE, THE SURGEON FOUND THAT THE PATIENT'S BOWEL HAD A PERFORATION LOCATED ON THE BACK OF THE DESCENDING COLON, WHERE AN ASSIST PORT WAS LOCATED. THE SURGEON REPAIRED THE DEFECT TO THE PATIENT'S BOWEL. THE CSR INDICATED THAT HE CONFIRMED WITH THE HOSPITAL THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE PRIMARY SURGICAL PROCEDURE AND THE HOSPITAL DOES NOT KNOW WHAT CAUSED OR CONTRIBUTED TO THE BOWEL INJURY SUSTAINED BY THE PATIENT. ACCORDING TO THE CSR, THE HOSPITAL REPORTED THAT THE PATIENT IS STABLE BUT IN CRITICAL CONDITION." } ], "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": "" } ] }