{ "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": "2955842-2013-04114", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131008", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121019", "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": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131009", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "509601", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131008", "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": "", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20131008", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Information" ] } ], "distributor_city": "", "date_report": "20130909", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3395441", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130909", "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": "3767856", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI RADICAL PROSTATECTOMY PROCEDURE AND ANTERIOR URETHROPEXY PROCEDURE ON (B)(6) 2012. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS PROSTATE CANCER. ACCORDING TO MEDICAL RECORDS PROVIDED, THE SURGEON DISCUSSED THE PROCEDURE AND RISKS WITH THE PATIENT AT A PRE-OPERATIVE VISIT. THE PATIENT WAS REPORTED TO UNDERSTAND THE RISKS, AND DESIRED THE ROBOTIC RADICAL PROSTATECTOMY SURGERY. BASED ON THE OPERATIVE REPORT, THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THERE WAS NO REPORT OF A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON POST-OPERATIVE DAY 1 AFTER HE WAS ABLE TO TOLERATE A REGULAR DIET, HIS URINE WAS CLEAR, HIS DRAIN WAS REMOVED, AND HIS LAB TESTS WERE NOTED TO BE GOOD. THE PATIENT WAS DISCHARGED ON ORAL ANTIBIOTICS AND PAIN MEDICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE FROM THE HOSPITAL ON (B)(6) 2012. NO MEDICAL RECORDS WERE PROVIDED THAT REPORT ANY INJURY, COMPLICATION, ADVERSE EVENT, OR OTHER UNTOWARD HEALTH CONDITION EXPERIENCED BY THE PATIENT." }, { "mdr_text_key": "11125392", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE 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 SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012. ACCORDING TO THE SYSTEM LOG, A RECOVERABLE ERROR 23004 POINTING TO PATIENT SIDE MANIPULATOR 3 (PSM3) OCCURRED DURING THE PROCEDURE. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. AN ERROR 23004 INDICATES THAT THE SERVO SYSTEM DETECTED A CONDITION THAT APPEARED TO BE CAUSED BY POSITIVE FEEDBACK. THIS ERROR IS INTENDED TO DETECT EXTREMELY RARE FAILURES IN THE INTERNAL MEMORY OR PROCESSOR THAT CONTROLS THE ROBOT MOTORS. THIS ERROR IS SUSCEPTIBLE TO GENERATING FALSE ALARMS, PARTICULARLY WHEN INSTRUMENTS WITH A LOT OF FRICTION ARE MOVED IN A RAPID AND/OR JERKY WAY BY THE USER. IT CAN ALSO OCCUR WHEN ARMS COLLIDE WITH ONE ANOTHER OR SOMETHING ELSE IN THE ENVIRONMENT. WHEN NO COLLISIONS AND/OR RAPID MOVEMENT WERE INVOLVED, IT PROBABLY REPRESENTS AN ENCODER FAILURE OR (MUCH LESS LIKELY) A COMPUTATIONAL ERROR ON THE REMOTE ARM CONTROLLER (RAC). THE SURGICAL STAFF WAS ABLE TO RECOVER FROM THE SYSTEM FAULT APPROXIMATELY 4 MINUTES AFTER THE ERROR CODE APPEARED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT CLAIMED THAT THE PATIENT SUFFERED PHYSICAL INJURIES AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN WHAT SPECIFIC INJURIES THE PATIENT SUSTAINED OR HOW THE ALLEGED INJURIES OCCURRED. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." } ], "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": "" } ] }