{ "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": "2955842-2016-00796", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20161111", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20161013", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "20161111", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "748285", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20161111", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "KS", "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": "20161111", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20161014", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6096249", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20161014", "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": "59718901", "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 ALLEGED 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. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT LOST 2700 CC OF BLOOD AND WAS GIVEN 4 UNITS OF BLOOD DUE TO A HEPATIC ARTERY INJURY. HOWEVER, THE ROOT CAUSES OF THE INJURY TO THE HEPATIC ARTERY AND THE REPORTED BLOOD LOSS ARE UNKNOWN." }, { "mdr_text_key": "59718902", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE SURGEON GOT INTO BLEEDING AND THE CASE WAS CONVERTED TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT LOST 2700 CC OF BLOOD AND WAS ALSO GIVEN 4 UNITS OF BLOOD. IT WAS ALSO REPORTED THAT THE SURGEON TRANSECTED AND CLIPPED THE COMMON DUCT DURING THE SURGICAL PROCEDURE. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS IN THE OR ON THE DAY OF THE SURGERY BUT HAD ALREADY LEFT WHEN THE REPORTED EVENT OCCURRED. AT THE BEGINNING OF THE SURGERY, THE CSR NOTED THE PATIENT'S GALLBLADDER AS BEING THICK AND ABNORMAL. HE ALSO STATED THAT THE PATIENT'S CYSTIC DUCT WAS VERY SHORT. FIREFLY WAS USED DURING THE SURGICAL PROCEDURE. AFTER THE REPORTED EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON AND THE SITE'S ROBOTICS COORDINATOR. ACCORDING TO THE CSR, THE SURGEON THOUGHT HE HAD CLIPPED AND TRANSECTED THE CYSTIC DUCT. HOWEVER, THE SURGEON HAD INADVERTENTLY CLIPPED AND TRANSECTED THE COMMON BILE DUCT INSTEAD. AFTER REPAIRING THE COMMON BILE DUCT, THE SURGEON PROCEEDED WITH THE SURGICAL PROCEDURE. AT AN UNSPECIFIED TIME LATER DURING THE SURGICAL PROCEDURE, THE SURGEON INADVERTENTLY INJURED THE PATIENT'S HEPATIC ARTERY. THE CSR DID NOT KNOW HOW OR WHY THE HEPATIC ARTERY WAS INJURED. IN ORDER TO CONTROL BLEEDING FROM THE HEPATIC ARTERY, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY. THE CSR WAS INFORMED THAT DURING THE OPEN SURGERY, THE PATIENT EXPERIENCED ADDITIONAL BLEEDING. HOWEVER, THE CSR DID NOT KNOW IF THE ADDITIONAL BLEEDING WAS RELATED TO THE INJURY TO THE HEPATIC ARTERY. THE SURGICAL PROCEDURE WAS COMPLETED VIA OPEN SURGERY. AT THE END OF THE OPERATION, THERE WAS NO INCIDENCE UPON PATIENT AWAKENING. ON (B)(6) 2016, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. SHE DID NOT KNOW THE CAUSE OF THE INJURY TO THE COMMON BILE DUCT. HOWEVER, THE ROBOTICS COORDINATOR STATED THAT SHE BELIEVES THE SURGEON DOES NOT THINK THE COMMON BILE DUCT INJURY WAS DUE TO ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM. AFTER THE COMMON BILE DUCT INJURY OCCURRED, THE SURGEON TIED OFF THE DUCT. THE COMMON BILE DUCT WAS REPORTEDLY REPAIRED AT ANOTHER UNSPECIFIED HOSPITAL. THE ROBOTICS COORDINATOR WAS UNABLE TO PROVIDE ANY DETAILS REGARDING THE INJURY TO THE HEPATIC ARTERY. THE CHOLECYSTECTOMY PROCEDURE WAS COMPLETED VIA OPEN SURGERY. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED TO HER KNOWLEDGE ALTHOUGH THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. SHE DID NOT KNOW THE PATIENT'S CURRENT STATUS." } ], "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": "" } ] }