{ "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": "2955842-2016-00417", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160603", "manufacturer_address_2": "", "pma_pmn_number": "K063220", "date_of_event": "20160524", "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": "20160603", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "353119", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160603", "brand_name": "DA VINCI S 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": "IS2000 A51P8", "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": "20250814", "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": "20160603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Tissue Damage", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20160524", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5698927", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160524", "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": "46567629", "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 INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON WAS REPORTEDLY NOT BLAMING THE DA VINCI SURGICAL SYSTEM FOR THE HOLE OR VESSEL DEFECT THAT WAS INITIALLY IDENTIFIED PRIOR TO THE CONVERSION TO OPEN SURGERY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, A VESSEL DEFECT WAS IDENTIFIED WITH AN INITIAL ESTIMATED BLOOD LOSS OF 30 ML. AFTER THE CASE WAS CONVERTED TO OPEN SURGERY, THE VESSEL HOLE REPORTEDLY WIDENED WHILE VASCULAR SURGEONS WERE ATTEMPTING TO REPAIR THE DEFECT. THE PATIENT REPORTEDLY LOST 2 L OF BLOOD DURING THE OPEN PROCEDURE AND REQUIRED 2 UNITS OF BLOOD POST-OPERATIVELY. HOWEVER, AT THIS TIME, THE CAUSE OF THE INITIAL VESSEL DEFECT IS UNKNOWN." }, { "mdr_text_key": "46567630", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING THE DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE THE PATIENT EXPERIENCED AN INTRA-OPERATIVE COMPLICATION WHICH REQUIRED CONVERSION TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE DA VINCI-ASSISTED SURGICAL PROCEDURE STARTED AT 12:15 PM. THE PROCEDURE PROGRESSED UNEVENTFULLY UNTIL THE ESOPHAGEAL DISSECTION WAS NEARLY COMPLETED. AT THAT POINT, MAJOR BLEEDING WAS OBSERVED AT 1:46 PM BY THE CONSOLE SURGEON. THE SURGEON WAS ABLE TO CONTROL THE BLEEDING QUICKLY BY APPLYING PRESSURE WITH AN UNSPECIFIED ROBOTIC INSTRUMENT. THE INITIAL REPORTER INDICATED THAT THE ESTIMATED BLOOD LOSS AT THAT STAGE OF THE SURGICAL PROCEDURE WAS 30 ML. THE SURGEON WAS UNABLE TO APPLY A CLIP OR SUTURES DUE TO POSITIONING; THEREFORE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY AT 2:20 PM WITH A VASCULAR CONSULTANT PRESENT AND IN CHARGE. THE INITIAL REPORTER INDICATED THAT THE SITE BELIEVES AN UNSPECIFIED THORACIC BRANCH OF THE AORTA HAD A HOLE. WHILE ATTEMPTING TO REPAIR THE HOLE VIA OPEN SURGERY, THE VESSEL DEFECT APPARENTLY WIDENED TO THE POINT WHERE THE AORTA BECAME INVOLVED. AFTER A THORACIC SURGEON WAS ABLE TO SUCCESSFULLY REPAIR THE VESSEL DEFECT WITH A PATCH, THE SURGICAL STAFF PROCEEDED WITH RESECTION OF THE ESOPHAGUS. DURING THE RESECTION PROCESS, LEAKAGE OF BLOOD WAS OBSERVED FROM THE STITCH HOLES WHERE THE PATCH HAD BEEN PLACED. AT THAT POINT, THE RESECTION OF THE ESOPHAGUS WAS DISCONTINUED IN ORDER TO REPAIR THE AORTA. THE ESTIMATED BLOOD LOSS DURING THE REPAIR WAS 2 L. THE PATIENT WAS STABLE POST-OPERATIVELY AND WAS READY TO LEAVE THE OPERATING ROOM (OR) AT 6:30 PM. ACCORDING TO THE INITIAL REPORTER, THE JOINT VASCULAR AND UPPER GI PLAN FOR THE PATIENT WAS TO REPLACE BLOOD PRODUCTS OVERNIGHT AND TO CONTINUE WITH THE OPERATION TO REMOVE THE CANCER VIA OPEN SURGERY THE FOLLOWING DAY. THE INITIAL REPORTER INDICATED THAT NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON 06/02/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON WAS UNABLE TO PROVIDE A DEFINITIVE CAUSE OF THE VESSEL DEFECT THAT HAD OCCURRED INTRA-OPERATIVELY. THE SURGEON INDICATED THAT A POSSIBLE CAUSE OF THE VESSEL DEFECT WAS POSSIBLE WEAKNESS THAT HAD DEVELOPED IN THE ARTERY WALL DUE TO THE USE OF AN UNSPECIFIED ENERGIZED INSTRUMENT. THE SURGEON INDICATED, HOWEVER, THAT HE WAS NOT ACTIVELY DISSECTING THE ESOPHAGUS IN THE AREA WHERE THE BLEEDING WAS IDENTIFIED. THE SURGEON REPORTEDLY WAS NOT BLAMING THE DA VINCI SURGICAL SYSTEM FOR THE INTRA-OPERATIVE COMPLICATION. THE SURGEON FURTHER CLARIFIED THAT THE VESSEL DEFECT WIDENED AFTER THE DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE HAD BEEN CONVERTED TO OPEN SURGERY. ACCORDING TO THE SURGEON, THE HOLE WIDENED WHILE VASCULAR SURGEONS WERE ATTEMPTING TO REPAIR THE VESSEL DEFECT. THE SURGEON CONFIRMED THAT THE PATCH WAS APPLIED TO THE VESSEL DEFECT VIA OPEN SURGERY. THE SURGEON ALSO CONFIRMED THAT THE DA VINCI SURGICAL SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE ADDITIONAL BLEEDING EXPERIENCED BY THE PATIENT AFTER THE CASE HAD BEEN CONVERTED TO OPEN SURGERY. POST-OPERATIVELY, THE PATIENT RECEIVED 2 UNITS OF BLOOD. THE PATIENT UNDERWENT OPEN SURGERY ON (B)(6) 2016 TO COMPLETE REMOVAL OF THE PATIENT'S CANCER. ON (B)(6) 2016, THE PATIENT DEVELOPED SIGNS OF AN INFECTION AT THE THORACOTOMY SITE. CURRENTLY, THE PATIENT IS BEING TREATED WITH UNSPECIFIED ANTIBIOTICS." } ], "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": "" } ] }