{ "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": "2955842-2025-17046", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250430", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250402", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250430", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190522", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1503748", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250430", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "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": "20250408", "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": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250430", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250402", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21939097", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250402", "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": "369307360", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE INSTRUMENT DRIVE ON PATIENT SIDE MANIPULATOR (PSM) #2 WAS NOT HOLDING THE STERILE ADAPTER (SA). THE ISSUE WAS IDENTIFIED WHILE THE OPERATING ROOM (OR) STAFF WAS SETTING UP FOR THE PROCEDURE. THE CUSTOMER HAD ALREADY RE-DRAPED BUT THE ISSUE REMAINED WITH A NEW DRAPE. WHEN THE CUSTOMER ENGAGED THE SA, IT SEEMED LIKE IT WOULD INITIALLY ENGAGE, BUT WHEN THEY TOUCHED THE SA ON PSM #2, IT FELL OFF. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED CHECKING THE WHEELS/DISK AND POGO PINS ON PSM #2. THE CALLER STATED ALL OF THE WHEELS AND THE POGO PINS SEEMED LIKE THEY WERE FREE TO MOVE AND SPONGY. THE CUSTOMER PRESSED THE INSTRUMENT RELEASE BUTTON ON THE PSM #2 AND THEN TRIED TO RE-ENGAGE THE SA ON THE PSM #2 WITH NO CHANGE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. AT THIS TIME, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS NOTED AFTER ANESTHESIA WAS ALREADY ADMINISTERED AND PORTS HAD BEEN PLACED. THERE WAS NO INJURY TO THE PATIENT. THE CUSTOMER WAS PERFORMING MEDIASTINAL MASS RESECTION. THE PROCEDURE WAS CONVERTED FROM AN SP DA VINCI-ASSISTED SURGICAL PROCEDURE TO AN XI DA VINCI-ASSISTED SURGICAL PROCEDURE." }, { "mdr_text_key": "369307361", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE. HOWEVER, THE FSE REPLACED PATIENT SIDE MANIPULATOR (PSM) #2 DUE TO THE CUSTOMER'S CLAIMED THAT THE INSTRUMENT STERILE ADAPTER POPPED OFF AND WOULD NOT STAY ENGAGED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED PSM #2 INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PSM WAS ANALYZED AND FOUND TO HAVE NO FAILURES. DURING VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. MULTIPLE STERILE ADAPTERS WERE INSTALLED BUT NO ISSUES WERE FOUND." } ], "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": "" } ] }