{ "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": "2955842-2025-37779", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250915", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20250818", "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": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20250915", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250220", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2088990", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250915", "brand_name": "DA VINCI XI", "generic_name": "SURGEON SIDE CONSOLE, RECONDITIONED", "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": "380723-17", "catalog_number": "380723", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Difficult to Open or Close", "Difficult to Open or Close" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/22/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20251103", "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": "20250915", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250818", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23057743", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250818", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "384088183", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "384088184", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MTM WAS ANALYZED, AND THE ERROR WAS REPLICATED DURING FAILURE ANALYSIS POINTING TO THE AXIS 1 POTENTIOMETER (POT). THE AXIS 1 POT WAS TESTED AND CONFIRMED TO BE THE SOURCE OF THE ISSUE." }, { "mdr_text_key": "380153296", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE CUSTOMER INDICATED THAT THE PROGRASP FORCEPS INSTRUMENT, INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) #4, WOULD NOT OPEN IN WHEN POSITIONED IN A CERTAIN ANGLE. THE FIRST PROGRASP FORCEPS INSTRUMENT WAS REMOVED AFTER THE CUSTOMER PRESSED THE EMERGENCY STOP (E-STOP) AND INSTRUMENT RELEASE KIT (IRK). HOWEVER, THE SECOND PROGRASP FORCEPS INSTRUMENT EXHIBITED THE SAME BEHAVIOR. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND NO RELEVANT ERRORS. THE TSE SUGGESTED TRYING ANOTHER PROGRASP FORCEPS INSTRUMENT FROM A DIFFERENT LOT ON ANOTHER USM. THE CUSTOMER INSTALLED THE SECOND PROGRASP FORCEPS INSTRUMENT ON USM #1 BUT THE SAME REACTION OCCURRED. THE TSE ALSO ADVISED THE CUSTOMER TO RESEAT THE STERILE ADAPTER. LATER, THE SAME ISSUE RETURNED WITH THE SECOND PROGRASP FORCEPS INSTRUMENT ON USM #1. THE TSE ASKED IF RESISTANCE OR NON-LINEAR MOVEMENT WAS FELT DURING USE, BUT NOTHING WAS REPORTED. THE ISSUE PERSISTED ONLY WHEN AN CERTAIN ANGLE WAS APPLIED TO THE INSTRUMENT TIP. THE TSE ADVISED SWAPPING THE INSTRUMENT CONTROLLED BY THE RIGHT HAND (USM #1) WITH ONE CONTROLLED BY THE OTHER HAND (USM #3) TO SEE IF THE ISSUE FOLLOWED, WHICH IT DID, CONFIRMING THE PROBLEM WITH THE LEFT USM. AS A RESULT OF THE REPORTED ISSUE, THE CUSTOMER ABORTED THE SURGERY. AT THAT TIME, THE PATIENT WAS UNDER ANESTHESIA AND PORTS HAD BEEN PLACED." }, { "mdr_text_key": "380153297", "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 FSE REPLACED THE RIGHT MASTER TOOL MANIPULATORS (MTM) TO RESOLVE THE GRIP CLOSING FAILURE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS." } ], "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": "10/20/2025" } ] }