{ "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": "2955842-2016-00617", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160819", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20160707", "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", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160819", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "540981", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160819", "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 A60P9B", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20160819", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Thrombus", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Thrombus" ] } ], "distributor_city": "", "date_report": "20160720", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5889967", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160720", "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": "52565294", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. APPROXIMATELY 3.5 HOURS INTO THE SURGICAL PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A SEQUENCE OF COMMUNICATION RELATED SYSTEM ERRORS WITHIN A 3 MINUTE TIME FRAME. AFTER THE SURGICAL STAFF REBOOTED THE DA VINCI SYSTEM, THE SURGEON WAS ABLE TO COMPLETE THE SURGICAL PROCEDURE WITH NO FURTHER SYSTEM ERRORS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING AND SHORTLY AFTER COMPLETION OF THE DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE SUPERIOR PANCREATICODUODENAL ARTERY. THE PATIENT REPORTEDLY RECEIVED TRANSFUSIONS AND UNDERWENT OPEN SURGERY TO CONTROL THE BLEEDING. HOWEVER, THE ROOT CAUSES OF THE OPERATIVE COMPLICATIONS ARE UNKNOWN. IN ADDITION, THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "52565295", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM A BRANCH OF THE SUPERIOR PANCREATICODUODENAL ARTERY. THE SURGEON REPORTEDLY USED A FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND COMPRESSION TO STOP THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, IT TOOK THE SURGICAL STAFF APPROXIMATELY 6 HOURS TO CONTROL THE BLEEDING. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. APPROXIMATELY 23 MINUTES AFTER THE DA VINCI-ASSISTED GASTRECTOMY PROCEDURE WAS COMPLETED AND THE PATIENT'S ABDOMEN WAS CLOSED, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. A BLOODY DRAIN WAS ALSO IDENTIFIED. A TRANSFUSION WAS ADMINISTERED AND THE PATIENT'S BLOOD PRESSURE RECOVERED TO 70 MM HGS. THE PATIENT WAS REPORTEDLY DIAGNOSED WITH HEMOPERITONEUM AND INTRAPERITONEAL OBSERVATION WAS PERFORMED WITH A LAPAROSCOPE. FRESH BLOOD AND BLOOD CLOTS WERE FOUND. AFTER SUCTIONING WAS PERFORMED, THE SOURCE OF THE BLEEDING WAS FOUND TO BE THE PANCREATIC HEAD. THE SURGEON MADE THE DECISION TO PERFORM OPEN SURGERY IN ORDER TO CONTROL THE BLEEDING. THE SURGEON APPLIED SUTURES TO THE SUPERIOR PANCREATICODUODENAL ARTERY. THE PATIENT WAS TAKEN TO THE ICU AFTER HEMOSTASIS WAS ACHIEVED AND VITALS WERE STABLE. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. THE SITE INDICATED THAT THE BLEEDING HAD STARTED WITHOUT ANY CAUSE. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE PANCREATICODUODENAL ARTERY WAS TRANSECTED AS PART OF THE PLANNED SURGICAL PROCEDURE. IN ORDER TO CONTROL BLEEDING FROM THE ARTERY, THE VESSEL WAS ACTUALLY COAGULATED AND NOT SUTURED AS INITIALLY REPORTED. AS OF THE DATE OF THIS REPORT, THE CAUSE OF THE BLEEDING FROM THE PANCREATIC HEAD IS STILL UNKNOWN." } ], "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": "" } ] }