{ "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": "2955842-2023-21211", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20231213", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20231116", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20231213", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20181102", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "327945", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231213", "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": "380601-33", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20231122", "device_report_product_code": "NAY", "device_age_text": "DA", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/05/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20231213", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20231116", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18321496", "removal_correction_number": "N/A", "number_devices_in_event": "", "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": "340139114", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT WAS CONFIRMED TO HAVE TAKEN PLACE DURING A SIMPLE PROSTATECTOMY PROCEDURE. THE SYSTEM WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE NOTED." }, { "mdr_text_key": "340139115", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "330428866", "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 FOUND THAT THE PRESENCE PIN WAS BROKEN ON PATIENT SIDE MANIPULATOR (PSM) 4 AND REPLACED THE PATIENT SIDE MANIPULATOR (PSM) AND RAN DIAGNOSTIC TEST ENGINEERING (DTE) AND CALIBRATION. THE SYSTEM PASSED DTE AND CALIBRATION. THE SITE REPORTED THAT THE BROKEN PIN WAS FOUND INSIDE OF THE STERILE ADAPTER THAT WAS ATTACHED TO PSM 4. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PSM WAS ANALYZED AND FOUND TO HAVE, THE RETENTION PLATE LEFT SPRING PIN WAS SEEN BROKEN OFF. THE UNIT WAS THEN INSTALLED ONTO FA'S SYSTEM AND STARTED UP IN NORMAL MODE WITH NO ISSUE SA AND INSTRUMENT ENGAGEMENT WERE INSPECTED AND AS EXPECTED, THE INSTRUMENTS WERE UNABLE TO ENGAGE DUE TO THE BROKEN PIN. THE PSM WAS THEN INSTALLED ONTO FA'S PFTP AND FAILED ALL INSTRUMENT ENGAGEMENT RELATED TESTS DUE TO THE BROKEN PIN. THE SPRING PINS WERE FOUND TO BE THE -03 VERSION PINS. THE UNIT PASSED SERVO TEST, PRELOAD MOTOR HEALTH CHECK, BRAKE SPEC TEST, BRAKE REPEATABILITY TEST, CLUTCH BUTTON CHECK, SA ENGAGEMENT CHECK, SINE CYCLE, SMOOTHNESS TEST, FRICTION TEST, FRICTION HIGH-SPEED SWEEP, AND BACKLASH TEST." }, { "mdr_text_key": "330428867", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CAMERA WOULD NOT RECOGNIZE ON THE UNIVERSAL SURGICAL MANIPULATOR (USM)4. THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) CALLED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) PRIOR TO STARTING THE CASE AND STATED THIS. THE ISI CTA RESEATED THE STERILE ADAPTER MULTIPLE TIMES ENSURING THAT THE DRAPE MATERIAL WAS BUNCHED UP WITH NO CHANGE. NO ERRORS OR SYSTEM MESSAGES WERE PRESENT. THE ISI TSE HAD THE ISI CTA ENSURE USM 4 WAS IN THE FULLY RETRACTED POSITION, ENSURING DRAPE MATERIAL WAS NOT CAUGHT UP IN THE PATH, WITH NO CHANGE. THE ISI CTA THEN TRIED ANOTHER CAMERA WITH NO CHANGE. THE ISI TSE RECOMMENDED RE-DRAPING THE SYSTEM. THE ISI CTA INSPECTED USM 4 AND FOUND THAT ONE OF THE STERILE ADAPTER PRESENCE PINS WAS MISSING. THE CUSTOMER WAS UNSURE HOW THEY WERE GOING TO PROCEED. THERE WAS A POSSIBILITY THAT THE CUSTOMER WOULD USE ANOTHER DA VINCI XI SYSTEM. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY." } ], "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": "03/28/2024" } ] }