{ "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": "2955842-2016-00483", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160701", "manufacturer_address_2": "", "pma_pmn_number": "K063220", "date_of_event": "20160603", "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": "20160701", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "420658", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160701", "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": [ "Poor Quality Image" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20160701", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20160603", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5765508", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160603", "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": "48676236", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS OF THE DATE OF THIS REPORT, THE HRSV HAS NOT BEEN RETURNED TO ISI FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE HRSV IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WHILE UNDERGOING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED A BLOOD LOSS OF 800 ML AFTER THE SURGICAL STAFF LOST 3D VISION." }, { "mdr_text_key": "48676237", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING THE DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE THE SURGICAL STAFF EXPERIENCED A LOSS OF 3D VISION. AS A RESULT, IT WAS ALLEGED THAT THE SURGICAL PROCEDURE WAS PROLONGED AND THE PATIENT EXPERIENCED AN ABNORMAL BLOOD LOSS. NO DETAILS WERE PROVIDED REGARDING THE SEVERITY OR QUANTITY OF THE BLOOD LOSS. IT IS UNKNOWN HOW LONG THE PROCEDURE WAS PROLONGED. ALSO, IT IS UNKNOWN IF MEDICAL INTERVENTION OR ADDITIONAL ANESTHESIA WAS ADMINISTERED DUE TO THE ABNORMAL BLOOD LOSS OR PROLONGED PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. ON (B)(6) 2016, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS ABLE TO REPLICATE THE REPORTED VISION ISSUES WITH THE DA VINCI SYSTEM. THE FSE RESOLVED THE REPORTED VISION ISSUES BY REPLACING THE HRSV AND BLUE FIBER CABLE. THE FSE THEN TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ON (B)(6) 2016, ISI CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ALLEGED VISION ISSUE OCCURRED JUST AT THE BEGINNING OF THE PROCEDURE. AT THE TIME THE EVENT OCCURRED, AN ISI CLINICAL SALES REPRESENTATIVE (CSR) AND FSE WERE PRESENT. THE FSE WAS UNABLE TO RESOLVE THE VISION ISSUE DURING THE CASE AND THE SURGEON MADE THE DECISION TO COMPLETE THE SURGICAL PROCEDURE IN 2D VISION. AS A RESULT OF THE ALLEGED VISION ISSUE, THE SITE INDICATED THAT THE PATIENT RECEIVED AN ADDITIONAL HOUR OF ANESTHESIA. IN ADDITION, THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 800 ML. NO BLOOD TRANSFUSIONS WERE ADMINISTERED. THE PATIENT REPORTEDLY TOLERATED THE SURGICAL PROCEDURE WELL." } ], "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": "" } ] }