{ "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": "2955842-2022-15147", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20221109", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20221010", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20221110", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190510", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2649907", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20221109", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE 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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-34", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20221027", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "No Device Output", "No Device Output" ], "reporter_state_code": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "health_professional": "Y", "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": "20221109", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20221010", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15765665", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221010", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "303393165", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED DURING A DA VINCI-ASSISTED PROCEDURE THAT ARM 3 OF THE SINGLE PORT (SP) SYSTEM ENCOUNTERED INSTRUMENT ENGAGEMENT ISSUES. THE OR STAFF STATED THEY UNDOCKED THE ARM AND RE-DRAPED BEFORE CALLING. THEY HAD ALSO POWER CYCLED AND TRIED MORE THAN ONE INSTRUMENT ON ARM 3, BUT ISSUES PERSISTED. THE PATIENT WAS ON THE TABLE, UNDER ANESTHESIA, AND PORTS HAD BEEN PLACED AT THE TIME. THE TSE REVIEWED THE LIVE LOGS AND FOUND ERRORS 23300 AND 31009. THE TSE INFORMED THE OR STAFF THAT ALL TROUBLESHOOTING STEPS HAD BEEN PERFORMED AND ARM 3 NEEDS SERVICE. IT WAS CONFIRMED FOLLOWING A FOLLOW-UP CALL THAT THE SURGEON CONVERTED TO AN XI MULTIPORT SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS." }, { "mdr_text_key": "303393166", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE PATIENT SIDE MANIPULATOR (PSM) AS IT WAS FOUND TO HAVE A BROKEN PRESENCE PIN AND VISIBLE DAMAGE ON THE CORNER OF THE PSM FROM POSSIBLY AN IMPACT/COLLISION. THE FSE NOTED THERE WERE NO ERRORS/ADVISORIES WHEN THE FSE ATTACHED STERILE ADAPTERS, BUT THERE WERE CONSISTENT INSTRUMENT ENGAGEMENT FAILURES EVERY TIME AN INSTRUMENT WAS INSTALLED ON PSM3. FOLLOWING SERVICE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PSM AND COMPLETED THE FAILURE ANALYSIS INVESTIGATION. THE PSM FAILED SYSTEM TEST \"PRELOAD SENSOR\" AND FAILED MULTIPLE TESTS ON THE TESTING PLATFORM. AS A FIX, THE STERILE ADAPTER SPRING PINS WILL BE UPGRADED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 23300 - TOOL ENGAGEMENT FAILURE ON PSM3, DISCS 1- 6 ARE NOT ENGAGED. 31009 - INSTRUMENT SENSORS MISSING. A TOOL WAS PARTIALLY DETECTED ON PSM3, ONE OR MORE OF THE TOOL SENSORS WERE NOT DETECTED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED FROM A SINGLE PORT (SP) SYSTEM TO AN XI (MULTI-PORT) SYSTEM AFTER THE START OF THE PROCEDURE DUE TO ISSUES WITH THE PSM. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT 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 FIELD IN SECTION E4 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }