{ "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": "2955842-2024-12571", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240326", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240229", "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": "20240326", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220216", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "409635", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240326", "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": "380601-45", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240304", "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": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "OK", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20240326", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "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": "20240229", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18981892", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240229", "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": "338660307", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A PLANNED DA VINCI-ASSISTED SP (SINGLE-PORT) PROSTATECTOMY PROCEDURE, AN ARM WAS NOT ACCEPTING STERILE ADAPTERS. THE STERILE ADAPTERS KEPT POPPING OFF ARM #3. AS A RESULT, THE CUSTOMER ELECTED TO CONVERT THE SURGICAL PROCEDURE TO A MULTI-PORT DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE." }, { "mdr_text_key": "338660308", "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 ASSEMBLY WAS ANALYZED, AND THE COMPLAINT WAS NOT CONFIRMED. THE FSE TESTED THE SYSTEM WITH A DRAPE PROVIDED BY THE CUSTOMER AND WAS REPORTEDLY INVOLVED WITH THE REPORTED ISSUE. THE FSE PLACED THE DRAPE AND STERILE ADAPTER ON PATIENT SURGICAL MANIPULATOR #3 (PSM3) APPROXIMATELY 20 TIMES WITH NO FAILURES. THE FSE THEN INSTALLED A TOOLING STERILE ADAPTER ON PSM3 APPROXIMATELY 40 TIMES WITHOUT ANY ISSUES. THE FSE HAD A SCRUB TECHNICIAN PRESENT WHILE TESTING AND THE TECHNICIAN AGREED THAT THE ARM WAS NOT FAILING. THE FSE WAS UNABLE TO REPRODUCE REPORTED PROBLEM. THE SYSTEM TESTED AND VERIFIED AS READY FOR USE. HOWEVER, THE FSE RETURNED TO THE SITE A FEW DAYS LATER TO FURTHER INVESTIGATE THE REPORTED ISSUE WHICH WAS REPORTEDLY REOCCURRING AND INTERMITTENT. THE FSE WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE AND REPLACED PSM3. THE FSE INSTRUCTED THE CUSTOMER ON PROPER DRAPE INSTALLATION. ISI RECEIVED PSM3 FOR FAILURE ANALYSIS EVALUATION AND THE REPORTED CUSTOMER REPORTED ISSUE WAS CONFIRMED AND REPLICATED. THE UNIT WAS INSTALLED ONTO AN IN-HOUSE SYSTEM AND STARTED UP IN NORMAL MODE WITHOUT TRIGGERING ANY FAULTS OR ERRORS. A STERILE ADAPTER WAS INSTALLED AND DURING ENGAGEMENT, THE STERILE ADAPTER WOULD POP OFF ON ONE SIDE. THE ISSUE WAS PERSISTENT WITH MULTIPLE STERILE ADAPTERS BUT WOULD STILL OCCASIONALLY ENGAGE A STERILE ADAPTER. THE UNIT WAS THEN INSTALLED ONTO A TEST PLATFORM WHERE IT PASSED ALL STANDARD TRIAGE TESTING. AS A PRECAUTION, THE STERILE ADAPTER MOUNT, DISTAL NOSE, SPRING PINS, AND PRINTED CIRCUIT ASSEMBLY WERE TO BE REPLACED." } ], "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": "" } ] }