{ "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": "2955842-2025-47341", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251204", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251107", "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": "GM", "manufacturer_contact_area_code": "408", "date_added": "20251204", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1100823", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251204", "brand_name": "DA VINCI SP", "generic_name": "VISION SYSTEM 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": "380941-34", "catalog_number": "380941", "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": [ "No Device Output", "No Device Output" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/12/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260519", "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": "20251204", "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": "20260310", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23720749", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251106", "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": "395267263", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "395267264", "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 AN SP ENDOSCOPE TO PERFORM FAILURE ANALYSIS. THE SP ENDOSCOPE WAS PLACED ON AN IN-HOUSE SYSTEM FOR FUNCTIONAL TESTING AND PASSED ALL QAP (QUALITY ASSURANCE PROCEDURES) CRITERIA, WITH CLEAR IMAGES AND SMOOTH ARTICULATION WITH NO FLASHING COLOR OBSERVED. A VISUAL INSPECTION WAS PERFORMED AND FOUND NO OBVIOUS FAILURE SUCH AS PHYSICAL DAMAGE, CORROSION, BENT/DEEP SCRATCHES ANYWHERE ON THE SP ENDOSCOPE. NO TEARS WERE OBSERVED. NO PRODUCT ISSUE WAS FOUND. AN OBSERVATION WAS IDENTIFIED BUT WAS UNRELATED TO THE CUSTOMER REPORTED COMPLAINT: THE SP ENDOSCOPE WAS FOUND TO HAVE A CORRODED BEARING. A VISUAL INSPECTION WAS PERFORMED AFTER THE ENDOSCOPE HOUSING WAS OPENED UP AND YELLOW COLORING WAS FOUND ON ONE OF THE BEARINGS." }, { "mdr_text_key": "386782223", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ENDOSCOPE RECOGNITION ISSUES AND THERE WAS A MESSAGE DISPLAYED ON THE VISION SIDE CART (VSC) TOUCHSCREEN INDICATING A NO VIDEO SIGNAL. PRIOR TO CALLING AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER HAD TRIED 3 DIFFERENT ENDOSCOPES WITHOUT SUCCESS. AS A RESULT OF THE CUSTOMER REPORTED ISSUE, THE SURGEON DECIDED TO CONVERT THE CASE TO TRADITIONAL LAPAROSCOPIC SURGERY AND ADDITIONAL PORTS WERE PLACED. THE CUSTOMER EXPLAINED THAT THEY HAD ALSO CLEANED THE ENDOSCOPE CONNECTOR WITH ALCOHOL, UNPLUGGED/PLUGGED SEVERAL TIMES, AND HAD PERFORMED A SYSTEM RESTART INCLUDING THE BREAKER ON THE VSC BUT THE ISSUE REMAINED. THE TSE ASKED THE CUSTOMER TO CHECK THE ENDOSCOPE CONTROLLER (EC) CONNECTION ON THE BACKSIDE AND TO ATTEMPT A SYSTEM RESTART BUT SINCE THE SURGERY WAS ONGOING, NO FURTHER TROUBLESHOOTING WAS POSSIBLE. THERE WAS NO REPORT OF PATIENT HARM, SERIOUS INCIDENT OR INJURY. THE ISSUE CAUSED A DELAY OF LESS THAN 15 MINUTES." }, { "mdr_text_key": "386782224", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER AND WAS INFORMED THAT THE ISSUE WAS RELATED TO THE ENDOSCOPES. ISI HAS NOT RECEIVED PRODUCT FOR FAILURE ANALYSIS EVALUATION." } ], "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": "03/10/2026" } ] }