{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2024-14936", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240523", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240426", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SZ", "manufacturer_contact_area_code": "408", "date_added": "20240523", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240104", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2055896", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240523", "brand_name": "DA VINCI SP", "generic_name": "VISION SYSTEM CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380941-50", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240517", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114742", "udi_public": "(01)00886874114742", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/28/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250820", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20240523", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Other" ], "patient_age": "48 YR", "patient_sex": "Male", "patient_weight": "65 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20240426", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19387927", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240426", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "343282964", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, AN ERROR OCCURRED WHEN THE ENDOSCOPE WAS CONNECTED TO THE ENDOSCOPIC CONTROLLER (EC). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) SUGGESTED DISCONNECTING THE ENDOSCOPE CONTROLLER AND POWER CYCLE THE SYSTEM INCLUDING A HARD POWER CYCLE AND EMERGENCY POWER OFF (EPO) ON THE PATIENT SIDE CART (PSC); THIS DID NOT SOLVE THE PROBLEM. THEN, TAKING THE PICTURE OF THE EVENT LOGS AND SENDING THEM TO TECHNICAL SUPPORT AND IN PARALLEL GUIDED THE CALLER TO FIND LINE WITH ERROR 319 AND GET THE P1 VALUE WAS SUGGESTED AND TO CHECK THE SOFTWARE VERSION OF THE SYSTEM. THE PICTURE WITH THE EVENT LOGS DID NOT COME IN. THE BIOMED PERFORMED SEVERAL HARD POWER CYCLES, EPO ON THE PSC, AND POWER CABLE DISCONNECT BUT NONE SOLVED THE PROBLEM. FURTHER LOG REVIEW SHOWED ERRORS ON THE PCC 3 ON THE UCC. THE TSE INFORMED THE CUSTOMER THAT THE SYSTEM NEEDED TO BE REPAIRED. THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE. THERE WERE NO ERRORS NOTED. ADDITIONAL PORTS WERE PLACED. INSTEAD OF THE SP ACCESS PORT, A TOTAL OF 6 ADDITIONAL TROCARS WERE NEEDED TO COMPLETE THE OPERATION." }, { "mdr_text_key": "343282965", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE WENT ON SITE, REPRODUCED THE ERROR 319 AND REPLACED THE EC TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE." }, { "mdr_text_key": "345600473", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ENDOSCOPE CONTROLLER (EC) HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM FA WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT BY INSTALLING THE UNIT INTO THE TEST SYSTEM AND IT FAILED WITH ERROR 319 AT SYSTEM START UP. FA FOUND THE FIBER CABLE WAS NOT FULLY INSERTED INSIDE THE TRANSCEIVER OF THE DUAL CAMERA INTERFACE BOARD (DCIB). THE FIBER CABLE WAS REINSERTED INTO THE TRANSCEIVER OF THE DCIB, AND THE EC WAS ABLE TO PROGRAM, AND EC NODE WAS SHOWN SUCCESSFULLY. FA PERFORMED LIGHT ENGINE SENSOR CHECK AND IT WAS LESS THAN <5%. A VISUAL INSPECTION DID NOT FIND ANY DAMAGE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/25/2024" } ] }