{ "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": "2955842-2016-00735", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20161014", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "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 REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20161014", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "680803", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20161014", "brand_name": "DA VINCI XI 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": "IS4000 A7.0P5C", "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": [ "Adverse Event Without Identified Device or Use Problem", "No Apparent Adverse Event", "Adverse Event Without Identified Device or Use Problem", "No Apparent Adverse Event" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20161014", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "90 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20160915", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6029174", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160915", "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": "57419978", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING, REQUIRING THE PATIENT TO UNDERGO A RE-OPERATION AND BLOOD TRANSFUSION. BASED ON THE INFORMATION PROVIDED REGARDING THE REPORTED EVENT, IT HAS BEEN DETERMINED THAT THE POST-OPERATIVE BLEEDING EXPERIENCED BY THE PATIENT WAS UNRELATED TO A MALFUNCTION DA VINCI SURGICAL SYSTEM INSTRUMENTS AND/OR ACCESSORIES, BUT WAS RATHER DUE TO THE USER'S UNDERSTANDING OF THE FUNCTIONALITY OF THE AUTO STOP FEATURE AVAILABLE FOR USE WITH THE BIPOLAR CAUTERY ENERGY ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. AS OF 10/13/2016 THERE HAVE BEEN NO OTHER REPORTS OF THE REPORTED ISSUE AT THE HOSPITAL." }, { "mdr_text_key": "57419979", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI ASSISTED CHOLECYSTECTOMY PROCEDURE ON AN UNSPECIFIED DATE, DURING THE PATIENT'S POST-OPERATIVE RECOVERY, THE PATIENT'S HEMOGLOBIN LEVELS HAD DROPPED. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE TO DETERMINE THE SOURCE OF THE BLEEDING; HOWEVER, THE HOSPITAL STATED THEY WERE NOT ABLE TO LOCATE THE SOURCE. THE PATIENT WAS ADMINISTERED 2 UNITS OF BLOOD AND THE POST-OPERATIVE BLEEDING WAS REPORTED TO HAVE RESOLVED ON ITS OWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON 10/12/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION, AFTER MEETING WITH THE APPLICABLE HOSPITAL STAFF, STATING THAT THE SURGEON DID NOT EXPERIENCE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PLANNED PROCEDURE. THE SURGEON USED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO SEAL VESSELS AND USED THE AUTO STOP FEATURE FOR THE BIPOLAR COAGULATION MODE ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. THE SURGEON'S INTERPRETATION OF THIS FEATURE WAS THAT COMPLETION OF THE AUTO STOP TONE WAS AN INDICATION THAT A VESSEL WAS ADEQUATELY SEALED. ACCORDING TO THE CSR, AFTER COMPLETION OF THE AUTO STOP TONE, THE SURGEON OBSERVED NO ACTIVE BLEEDING FROM THE PATIENT'S VESSELS, THEREFORE THE SURGEON BELIEVED THAT THE PATIENT'S VESSELS WERE PROPERLY SEALED AND REQUIRED NO ADDITIONAL SEAL. THE SURGEON AND HOSPITAL CONCLUDED THAT ALTHOUGH HE WAS ABLE TO ACHIEVE HEMOSTASIS WITH ONE SEAL, THE LIKELY CAUSE OF THE POST-OPERATIVE BLEEDING OCCURRED DUE TO AN IMPROPERLY SEALED VESSEL THAT BLED AFTER ABDOMINAL INSUFFLATION WAS REDUCED. THE HOSPITAL INDICATED THAT MORE THAN ONE SEAL SHOULD HAVE BEEN PERFORMED TO ENSURE THAT THE PATIENT'S VESSEL(S) WERE ADEQUATELY SEALED. THE CSR PROVIDED THE HOSPITAL INFORMATION ABOUT THE AUTO STOP FEATURE STATING THAT THE AUTO STOP FEATURE CAN BE USED IN CONJUNCTION WITH THE BIPOLAR SOFT COAG MODE AND THAT AUTO STOP ENDS BIPOLAR CAUTERY ACTIVATION AUTOMATICALLY BEFORE TISSUE ADHERES TO THE BIPOLAR INSTRUMENT. THE DATE OF THE REPORTED EVENT WAS NOT PROVIDED BY THE HOSPITAL AND THERE IS NO VIDEO RECORDING OF THE PLANNED SURGICAL PROCEDURE." } ], "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": "" } ] }