{ "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": "2955842-2015-00752", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150515", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150505", "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": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150518", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "320595", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150515", "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 A6.0P9", "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": [ "Poor Quality Image" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20150515", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20150505", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4775656", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150505", "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": "5801366", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT TOWARDS THE END OF A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGEON LOST VISION THROUGH THE RIGHT EYE WHILE LOOKING THROUGH THE HIGH RESOLUTION STEREO VIEW (HRSV) ON THE SURGEON SIDE CONSOLE (SSC). AS A RESULT OF THE VISION ISSUE, THE SURGEON MADE THE DECISION TO CONTINUE WITH THE SURGICAL PROCEDURE IN 2D VISION INSTEAD OF 3D VISION. THE VISION ISSUE OCCURRED PRIOR TO CREATION OF AN ANASTOMOSIS. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND GATHERED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE SURGEON, THE APPLIED FORCE OF THE INSTRUMENTS WAS DISPROPORTIONED IN 2D VISION AND FORCE FEEDBACK WAS MISSING. AS A RESULT, THE SURGEON CLAIMED THAT TISSUES WERE TORN AND THE TOTAL BLOOD LOSS OF THE SURGICAL PROCEDURE WAS 1500 ML. THE SURGEON INDICATED THAT THE SURGICAL PROCEDURE WAS COMPLETED IN 2D VISION AND THE PATIENT DID NOT EXPERIENCE ANY LONG-LASTING INJURIES. ON (B)(4) 2015, THE ISI TECHNICAL FIELD SPECIALIST (TFS) CONTACTED THE SITE'S BIOMED DEPARTMENT FOR TROUBLESHOOTING. THE SITE'S BIOMED DEPARTMENT RESOLVED THE VISION ISSUE BY CLEANING THE RIGHT EYE LENSE OF THE CAMERA." }, { "mdr_text_key": "13447769", "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. 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. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015. DURING THE SURGICAL PROCEDURE, A SYSTEM ERROR CODE 23075 OCCURRED THREE TIMES. A SYSTEM ERROR CODE 23075 IS GENERATED WHEN THE SYSTEM DETECTS CONDITIONS CONSISTENT WITH THE MASTER TOOL MANIPULATOR (MTM) MOVING IN FOLLOWING WITHOUT THE SURGEON'S HANDS ON THE HANDLE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON CLAIMED THAT THE PATIENT SUSTAINED TORN TISSUE WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE IN 2D VISION. HOWEVER, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE 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": "" } ] }