{ "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": "2955842-2026-01126", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260113", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251218", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260113", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250508", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "122234", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260113", "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": "380941-51", "catalog_number": "380941", "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": "00886874114742", "udi_public": "(01)00886874114742", "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": "20260507", "health_professional": "Y", "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": "20260113", "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": "20260428", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24058637", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251218", "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": "400559933", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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." }, { "mdr_text_key": "400559934", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "390100332", "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 WAS 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. CONCOMITANT PRODUCT(S): SP 0 DEGREE ENDOSCOPE (PART #430600-03)." }, { "mdr_text_key": "390100333", "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 ERRORS ON THE ENDOSCOPE. THE CUSTOMER POWER CYCLED THE SYSTEM AND RESEATED THE ENDOSCOPE BUT THE ISSUE REMAINED. THE STAFF DID NOT KNOW THE ERROR CODE BUT STATED THAT THERE WAS MESSAGING INDICATING THAT SELF-TEST HAS FAILED AND TO REPLACE THE ENDOSCOPE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER HARD POWER CYCLE THE VISION SIDE CART (VSC) AND RESEAT THE ENDOSCOPE MULTIPLE TIMES BUT THE ISSUE REMAINED. THE CUSTOMER DID NOT HAVE A BACKUP ENDOSCOPE AVAILABLE AND STATED THAT THEY WILL CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY." } ], "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": "04/28/2026" } ] }