{ "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": "Y", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "7137532", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20171221", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20171213", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "report_date": "20171219", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20171221", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "918186", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171221", "brand_name": "DA VINCI ROBOT XI SURGICAL SYSTEM", "generic_name": "SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT", "manufacturer_d_name": "INTUITIVE SURGICAL, INC.", "manufacturer_d_address_1": "1266 KIFER RD", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "PHYSICIAN", "model_number": "XI-SS4000", "catalog_number": "", "lot_number": "", "other_id_number": "SURGEON CONSOLE 396891, PT. 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A BLUNT TROCHAR WAS PLACED, AND 6 PORTS WERE PLACED UNDER DIRECT VISION. THE ROBOT ARMS WERE PLACED IN STANDARD FASHION TO TRIANGULATE THE RETROPERITONEUM. THE DA VINCI XI ROBOTIC SYSTEM WAS THEN DOCKED OVER THE PATIENT'S FLANK. INITIAL INSPECTION OF THE BOWEL AND ABDOMINAL CONTENTS WERE UNCOMPLICATED, WITH NO EVIDENCE OF INJURY. THE PROCEDURE WAS INITIATED WITH MOBILIZATION OF THE COLON TO REVEAL THE RETROPERITONEUM. THE SPERMATIC CORD WAS THEN IDENTIFIED AT ITS ORIGIN ON THE LEFT RENAL VEIN. AT THIS POINT THE ROBOTIC SYSTEM ALERTED AND AN UNRECOVERABLE FAULT IN THE 3RD ROBOTIC ARM WAS DISCOVERED. THE ARM WAS LOCKED IN PLACE AND THE PROCEDURE COULD NOT CONTINUE. THE ERROR CODE 319 WAS NOTED AND THE ARM COULD NOT BE MOVED. THE SURGEON AND TEAM FOLLOWED THE INSTRUCTIONS ON THE SCREEN AND REBOOTED THE SYSTEM THREE TIMES WITHOUT RESOLUTION. THEY CALLED THE INTUITIVE INC. SUPPORT AND THE DA VINCI REP TRIED TO TROUBLE SHOOT THE PROBLEM WITHOUT SUCCESS. THE FINAL ADVICE WAS A ROBOTIC ARM REPLACEMENT THE FOLLOWING DAY. THE SURGEON WAS TOLD THAT IT WAS A COMPLETE FAILURE OF THE ROBOT. THE CASE WAS ABORTED AFTER THE GONADAL VEINS WERE LIGATED AND THE REMAINING DISTAL PORTION OF THE SPERMATIC CORD WAS DISSECTED FREE. THE PATIENT RETURNED FOR ADDITIONAL SURGERY A FEW DAYS LATER. MANUFACTURER RESPONSE FOR DA VINCI ROBOT XI SURGICAL SYSTEM, DA VINCI ROBOT XI (PER SITE REPORTER): THE MANUFACTURER REPAIRED THE DEVICE THE FOLLOWING DAY AND HAS THE BROKEN PARTS." } ], "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": "" } ] }