{ "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": "2955842-2026-04713", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20260218", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260121", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260218", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "50083", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260218", "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": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Sense" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/18/2026;05/21/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260218", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260603", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24381616", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260121", "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": "396753924", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "396753925", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CUSTOMER RETURNED TWO MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENTS WITH RECOGNITION ISSUES. THE RECOGNITION ISSUES REPORTEDLY CONTRIBUTED TO THE CONVERSION FROM A SINGLE-PORT SYSTEM TO MULTI-PORT. TWO MCS INSTRUMENTS WERE RECEIVED AS CONCOMITANT PRODUCTS FOR THIS EVENT. THE MCS INSTRUMENTS WERE RECEIVED FOR FAILURE ANALYSIS INVESTIGATIONS. ONE OF THE MSC INSTRUMENTS (S10190625 0003) FAILED FUNCTIONAL TEST FAIL-INSTRUMENT TIP DETECTION DURING TESTING. TWO DIFFERENT IN-HOUSE TIPS WERE INSTALLED ON THE INSTRUMENT FOR TESTING AND BOTH ATTEMPTS FAILED TIP DETECTION. THE HOUSING WAS REMOVED FOR INSPECTION AND FOUND NO PHYSICAL DAMAGE ON THE EXTERIOR OR INTERIOR OF THE INSTRUMENT. THE OTHER MCS INSTRUMENT (S10190627 0003) WAS TESTED WITH NO PRODUCT ISSUES IDENTIFIED. RECOGNITION AND ENGAGEMENT TESTING PASSED WITH NO MSC TIP ERRORS OBSERVED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS AND PASSED INTUITIVE MOTION. THE INSTRUMENT PASSED ENERGY DELIVERY TESTING IN VARIOUS GRIP ORIENTATIONS. THE INSTRUMENT ALSO PASSED THE ELECTRICAL CONTINUITY TEST. THE SCISSOR TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS RETESTED AND PASSED ALL IN-HOUSE TESTING ON THREE ATTEMPTS. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PHYSICAL DAMAGE. THE HOUSING WAS REMOVED FOR INSPECTION AND FOUND NO DAMAGE." }, { "mdr_text_key": "403359676", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: G3, G6, H2, H6, H11. ONE OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENTS (S10190625 0003) PREVIOUSLY INVESTIGATED WAS EVALUATED FOR ADVANCED FAILURE ANALYSIS. THE INITIAL TIP DETECTION FAILURE WAS CONFIRMED. THE INSTRUMENT'S HOUSING WAS REMOVED, AND THE INSTRUMENT'S ROLL SECTOR GEAR, PROXIMAL DRIVE ROD, AND DRIVE ROD CLAMP ALL APPEARED TO BE NOMINAL. MANUALLY ARTICULATING THE GRIP KNOB DID NOT APPEAR TO EXHIBIT ANY OBVIOUS ISSUES. ADDITIONALLY, THIS VERSION OF THE INSTRUMENT HAS A KNOWN SOFTWARE ISSUE THAT CAN LEAD TO TIP DETECTION FAILURES WHEN INSTALLING THE MCS ON THE SYSTEM. THE TIP DETECTION FAILURE IS CAUSED BY THE SYSTEM SOFTWARE AND IS NOT AN ISSUE WITH THE INSTRUMENT ITSELF." }, { "mdr_text_key": "403359677", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "393323281", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE IS NO ALLEGATION AGAINST A DA VINCI PRODUCT ASSOCIATED WITH THIS EVENT, THEREFORE; NO PRODUCT WAS RETURNED FOR FAILURE ANALYSIS INVESTIGATION." }, { "mdr_text_key": "393323282", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A DA VINCI-ASSISTED PROSTATECTOMY - RADICAL EXTRAPERITONEAL W/ LYMPHADENECTOMY SURGICAL PROCEDURE WAS CONVERTED FROM SINGLE-PORT TO MULTI-PORT AND ADDITIONAL PORTS WERE PLACED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/16/2026;06/03/2026" } ] }