{ "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": "2955842-2019-10788", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20191011", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20190508", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20191011", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "972952", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191011", "brand_name": "DA VINCI", "generic_name": "PATIENT SIDE CART, 4-ARM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380652-44", "catalog_number": "N/A", "lot_number": "N/A", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/16/2021", "mfr_report_type": "", "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": "20191011", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20190920", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9180062", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190920", "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": "325834635", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PRODUCT INFORMATION IN SECTION D HAS BEEN UPDATED TO PROVIDED CORRECTED INFORMATION." }, { "mdr_text_key": "325834636", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "173177995", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. ALTHOUGH IT WAS REPORTED THAT THE BOWEL PERFORATION WAS RELATED TO ELECTROCAUTERY, THERE IS NO SPECIFIC ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ISI CONTACTED THE INITIAL REPORTER AS WELL AS TWO OTHER PHYSICIANS AT THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE PHYSICIANS WERE NOT WILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT. THE FOLLOWING INFORMATION IS UNKNOWN: THE DATE THE EVENT OCCURRED, THE PROCEDURE OUTCOME, WHAT SPECIFIC ENERGY DEVICE WAS INVOLVED WITH THE BOWEL PERFORATION, WHEN THE BOWEL PERFORATION WAS IDENTIFIED, WHAT MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE BOWEL PERFORATION, AND THE CURRENT STATUS OF THE PATIENT. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT REPORTEDLY UNDERWENT AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE AND ALLEGEDLY SUSTAINED A BOWEL PERFORATION RELATED TO ELECTROCAUTERY. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO DIRECT ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." }, { "mdr_text_key": "173177996", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT A PATIENT HAD UNDERGONE AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE AND A BOWEL PERFORATION WAS IDENTIFIED. THE INITIAL REPORTER, A SURGEON, COMMENTED THAT THE BOWEL PERFORATION WAS RELATED TO ELECTROCAUTERY. HOWEVER, AT THIS TIME, THE ROOT CAUSE AND SEVERITY OF THE OPERATIVE COMPLICATION ARE UNKNOWN. IT IS ALSO UNCLEAR WHAT MEDICAL INTERVENTION, IF ANY, WAS ADMINISTERED DUE TO THE BOWEL PERFORATION." } ], "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": "08/12/2021" } ] }