{ "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": "2955842-2026-01127", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260114", "manufacturer_address_2": "", "pma_pmn_number": "K250786", "date_of_event": "20251220", "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", "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": "20260114", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "126777", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260114", "brand_name": "DA VINCI SP ENDOSCOPE, 0°", "generic_name": "ENDOSCOPE, 0°", "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": "430600-03", "catalog_number": "430600", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260105", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874123188", "udi_public": "(01)00886874123188", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Display or Visual Feedback Problem" ], "reporter_state_code": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/07/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260518", "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": "20260114", "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" ] } ], "distributor_city": "", "date_report": "20260501", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24072341", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251220", "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": "401575515", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "401575516", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: G3, G6, H2, AND H11. ADDITIONAL INFORMATION: ADVANCED FAILURE ANALYSIS INVESTIGATION WAS CONDUCTED FOR THE SP 0 DEGREE ENDOSCOPE INVOLVED WITH THE REPORTED EVENT IN ADDITION TO A NUMBER OF RETURNED ENDOSCOPES FROM THE SITE. A VARIETY OF TESTS WERE PERFORMED TO ASSESS PRODUCT PERFORMANCE AND REPLICATED REPORTED ISSUES OF LOSS OF VIDEO DURING PROCEDURE. THREE UNITS UNDERWENT TESTING IN THE LAB, AND NO ISSUES WERE IDENTIFIED. TWO ADDITIONAL ENDOSCOPES WERE SUBJECTED TO THERMAL CHAMBER TESTING UP TO 137°C, BOTH COMPLETING THE TEST WITHOUT INCIDENT. ONE ENDOSCOPE SUCCESSFULLY PASSED A REPROCESSING NO DRY TEST, WHILE ANOTHER FOUR UNITS COMPLETED 15 CYCLES ON THE ARTICULATION TESTER WITH NO OBSERVED FAILURES. ADDITIONALLY, FEEDBACK FROM THE CUSTOMER INDICATED THAT THE MOST LIKELY CAUSE OF THE ISSUES WAS RESIDUAL MOISTURE RESULTING FROM INCOMPLETE DRYING. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "390278028", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SP 0 DEGREE ENDOSCOPE WAS RECEIVED FOR FAILURE ANALYSIS. THE ENDOSCOPE WAS FOUND TO HAVE COMMUNICATION FAILURES BASED OFF LOG REVIEW BUT WAS NOT REPLICATED DURING IN-HOUSE TESTING. THE ENDOSCOPE WAS TESTED AND PLACED ON IN-HOUSE SYSTEM OR EQUIVALENT FOR FUNCTIONAL TESTING AND PASSED. STEREO CALIBRATION, ENDOSCOPE FOCUS TEST, AND COLOR RECOGNITION WERE PERFORMED AND PASSED. IMAGES WERE CLEAR, DEWARPED AND NOT GRAINY. NO NOISE OR MOTION BLUR WAS SEEN. THE BUTTONS WERE FULLY FUNCTIONAL AND MOVED INTUITIVELY. FIRST EDT TESTING PASSED. LEAK TESTS WERE PERFORMED AND PASSED. THE MANIFOLD MEMBRANE WAS INSPECTED WITH THE BORESCOPE PROBE AND NO PUNCTURES OR TEARS WERE FOUND." }, { "mdr_text_key": "390278029", "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 IMAGE THROUGH THE ENDOSCOPE WENT BLACK. THE CUSTOMER DID NOT HAVE A BACKUP ENDOSCOPE AVAILABLE FOR TROUBLESHOOTING. THE CUSTOMER REPORTEDLY HAD AN INSTRUMENT ON THE PATIENT'S GALL BLADDER. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF THEY COULD VISUALIZE THE INSTRUMENTS AND IF THEY HAD A THIRD PARTY SCOPE TO USE. THE SURGICAL STAFF PROCEEDED WITH LAPAROSCOPIC SCOPE AND THE TSE WALKED THE CUSTOMER THROUGH REMOVING INSTRUMENTS MANUALLY. THE CUSTOMER WAS ABLE TO REMOVE THE INSTRUMENTS AND UNDOCK FROM THE PATIENT. THE CUSTOMER TRIED POWER CYCLING THE SYSTEM BUT THE ENDOSCOPE WOULD NOT PASS A SELF-TEST. THE CUSTOMER THEN ELECTED TO CONVERT THE PROCEDURE TO MULTI-PORT SURGERY IN ORDER TO COMPLETE THE CASE." } ], "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": "05/01/2026" } ] }