{ "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": "2955842-2014-05113", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140821", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140722", "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": "20140821", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "504646", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140821", "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 A6.0P8", "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": [ "Leak/Splash" ], "reporter_state_code": "CA", "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": "20140821", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20140722", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4027884", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140722", "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": "15473051", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-OPERATIVE LEAK EXPERIENCED BY THE PATIENT. ISI HAS CONTACTED THE SITE TO VERIFY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI COLORECTAL PROCEDURE, THE PATIENT EXPERIENCED A MINOR LEAK, REQUIRING THE PATIENT TO UNDERGO AN ADDITIONAL LAPAROSCOPIC PROCEDURE FOR REPAIR OF THE LEAK. THERE WAS NO ALLEGATION THAT THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT." }, { "mdr_text_key": "15116317", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT 10 DAYS POST A DA VINCI COLORECTAL PROCEDURE ON (B)(6) 2014, THE PATIENT RETURNED TO THE HOSPITAL PRESENTING SYMPTOMS OF A LEAK. IT WAS DISCOVERED THAT THE PATIENT HAD A MINOR LEAK AND UNDERWENT A LAPAROSCOPIC PROCEDURE TO REPAIR THE DEFECT. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, HE WAS PRESENT DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT THE CASE WENT WELL AND NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT HE WAS TOLD BY THE SURGEON THAT THE PATIENT HAD POSSIBLY DEVELOPED A HEMATOMA AT THE LEAK SITE. NO OTHER INFORMATION 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": "" } ] }