{ "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": "2955842-2016-00536", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160729", "manufacturer_address_2": "", "pma_pmn_number": "K063221", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "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": "", "manufacturer_contact_area_code": "", "date_added": "20160729", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "485654", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160729", "brand_name": "DA VINCI XI 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": "IS4000", "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": [ "Use of Device Problem", "Physical Resistance" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20160729", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20160629", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5835052", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160629", "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": "50816687", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE(S). HOWEVER, IT IS UNCLEAR HOW THE REPORTED LUNG AND LIVER INJURIES OCCURRED. IT IS ALSO UNKNOWN IF THE INJURIES OCCURRED DURING MANUAL INSERTION OF AN INSTRUMENT OR WITH THE USE OF THE DA VINCI SURGICAL SYSTEM'S GUIDED TOOL CHANGE FEATURE. THE GUIDED TOOL CHANGE FEATURE PROVIDES AN EFFICIENT AND SAFE METHOD FOR INSTRUMENT EXCHANGE OR REINSERTION. THE GUIDED TOOL CHANGE SPECIFICALLY HELPS GUIDE THE INSTRUMENT TIP TO A LOCATION JUST SHORT OF THE LAST POSITION OF THE PREVIOUSLY INSTALLED INSTRUMENT TIP. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. ACCORDING TO THE DA VINCI XI SURGICAL SYSTEM MANUAL, THE FOLLOWING WARNINGS/CAUTIONS ARE NOTED FOR MANUALLY INSERTING AN INSTRUMENT: WARNING: THE INSTRUMENT MAY NOT BE IMMEDIATELY VISIBLE WHEN BEING MOVED FROM THE CANNULA INTO THE PATIENT. MOVE THE ENDOSCOPE TO VISUALIZE THE INSTRUMENT AND USE APPROPRIATE CAUTION WHEN INSERTING INSTRUMENTS INTO THE PATIENT. CAUTION: AFTER INSERTING, ENSURE ALL INSTALLED INSTRUMENTS ARE VISIBLE IN THE SURGEON CONSOLE VIEW BEFORE PROCEEDING. THIS VISUAL CHECK PREVENTS INADVERTENT HARM TO THE PATIENT. FURTHERMORE, THE FOLLOWING WARNINGS/CAUTIONS ARE NOTED FOR THE GUIDE TOOL CHANGE: WARNING: USE APPROPRIATE CAUTION WHEN INSERTING INSTRUMENTS INTO THE PATIENT BY VISUALIZING THE INSTRUMENT ON THE VISION CART TOUCHSCREEN AS IT IS BEING INSERTED. CAUTION: EVEN THOUGH THE SYSTEM WILL BRING THE TIP TO ITS PREVIOUS POSITION, THE SYSTEM HAS NO KNOWLEDGE OF OBSTACLES THAT MAY HAVE ENTERED THE INSTRUMENT'S PATH. BEST PRACTICE IS TO OBSERVE THE INSTRUMENT TIP COMING INTO VIEW ON THE PATIENT-SIDE MONITOR. ISI HAS ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY SUSTAINED A LIVER INJURY WHICH REQUIRED FURTHER SURGICAL INTERVENTION ON POST-OPERATIVE DAY 1. HOWEVER, THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE REPORTED OPERATIVE COMPLICATIONS. IN ADDITION, THERE HAVE BEEN NO REPORTED RECURRENCES OF SIMILAR EVENTS FROM THE SITE OR SURGEON." }, { "mdr_text_key": "50816688", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A PATIENT SUSTAINED AN INJURY TO THE LUNG AND AN INJURY TO THE LIVER. DETAILS REGARDING WHAT SPECIFIC TYPES OF INJURIES WERE SUSTAINED BY THE PATIENT WERE NOT PROVIDED. IN ADDITION, THE DATE AS TO WHEN THE DA VINCI SURGICAL PROCEDURE WAS PERFORMED IS UNKNOWN. ACCORDING TO THE SURGEON, THE INJURIES ALLEGEDLY OCCURRED DURING THE INSERTION OF A DYNAMIC ATRIAL RETRACTOR INSTRUMENT. THE SURGEON EXPLAINED THAT THERE IS ROUTINELY MORE RESISTANCE TO PASS INSTRUMENTS ON THE XI THAN ON THE SI SURGICAL SYSTEMS. THE SURGEON WAS REFERRING TO THE DIFFERENCE IN RESISTANCE WHEN INSERTING AN INSTRUMENT THROUGH A CANNULA SEAL ON THE DA VINCI XI SURGICAL SYSTEM COMPARED TO THE DA VINCI SI SURGICAL SYSTEM. THE SURGEON FURTHER STATED THAT THERE HAS BEEN NO RECURRENCE OF THE ISSUE AT THE SITE AND THE SURGICAL TEAM LEARNED FROM THE EXPERIENCE WITH A BETTER UNDERSTANDING OF THE RESISTANCE DIFFERENCES BETWEEN THE CANNULA SEALS OF THE TWO DA VINCI SURGICAL SYSTEMS. THE PATIENT REPORTEDLY REQUIRED SURGERY TO REPAIR THE LIVER INJURY THE DAY AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED." } ], "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": "" } ] }