{ "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": "2955842-2024-17924", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240808", "manufacturer_address_2": "", "pma_pmn_number": "K212101", "date_of_event": "20240705", "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", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20240808", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230821", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1560408", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240808", "brand_name": "DA VINCI SP", "generic_name": "CAMERA INSTRUMENT,FIREFLY,SP", "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": "430077-01", "catalog_number": "430077", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240726", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874122228", "udi_public": "(01)00886874122228", "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", "Display or Visual Feedback Problem" ], "reporter_state_code": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/16/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20240808", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "77 YR", "patient_sex": "Male", "patient_weight": "118 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240715", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19945332", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240715", "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": "358238842", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "358238843", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: \"PATIENT HERE FOR PARTIAL NEPHRECTOMY ON [REDACTED]. PATIENT INTERVIEWED AND ANESTHESIA/PROCEDURAL CONSENT VERIFIED. ROOM SET UP AND READY TO GO. PATIENT IN ROOM AT 3:35 PM, PATIENT THEN PUT TO SLEEP WITHOUT ISSUE. PATIENT PREPPED AND DRAPED IN NORMAL STERILE FASHION. PROCEDURAL TIME OUT ACHIEVED PRIOR TO INCISION, AND EVERYTHING CONFIRMED PRIOR TO INCISION. 4:00 PM RN WENT TO HOOK UP DAVINCI CORDS AND CAMERA AS PER NORMAL, CAMERA SHOWED A FAULT ON THE DAVINCI TOWER. AT THIS POINT, WE SPENT THE NEXT 45 MINUTES TROUBLESHOOTING THE CAMERA AND ON PHONE WITH INTUITIVE SUPPORT. IT WAS DEEMED BY INTUITIVE SUPPORT THAT THERE WAS A NONRECOVERABLE FAULT WITHIN THE CAMERA, AND IT IS UNABLE TO BE FIXED. OTHER DEVINCI EQUIPMENT USED IN EARLIER CASES AND IN STERILIZATION PROCESS. DUE TO THE NATURE OF THE PATIENT'S CASE, WE COULD NOT CONTINUE WITH THE OPERATION NOR CONVERT. MD BROKE SCRUB AND IMMEDIATELY SPOKE WITH PATIENTS' FAMILY ABOUT THE SCENARIO. IT WAS AGREED WITH FAMILY, THAT THE BEST RECOMMENDATION WOULD BE TO WAKE THE PATIENT UP AND RESCHEDULE. FAMILY WAS UNDERSTANDING. AT THIS POINT, PATIENT CLOSING COMMENCED, AND ALL COUNTS WERE CORRECT AT END OF PROCEDURE. PATIENT WOKEN UP AND TRANSFERRED TO RECOVERY AT 5:07 PM WITHOUT TROUBLE.\"." }, { "mdr_text_key": "348871397", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT ERRORS OCCURRED WHEN THE CAMERA WAS CONNECTED. THE CUSTOMER CLEANED THE CAMERA CONNECTOR, AND POWER CYCLED THE SYSTEM, AND THE ISSUE PERSISTED. THE SYSTEM LOGS CONFIRMED ERRORS. THE ISI TSE RECOMMENDED REPLACING THE CAMERA. THE CUSTOMER STATED THAT THEIR ENDOSCOPES WERE ALL BEING REPROCESSED. THE ISI TSE RECOMMENDED RETURNING THE CAMERA FOR EXCHANGE AND FAILURE ANALYSIS. THE PROCEDURE WAS ABORTED AND RESCHEDULED." }, { "mdr_text_key": "348871398", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ERROR MESSAGES. THE IN-HOUSE SYSTEM FAILED TO COMMUNICATE WITH THE ENDOSCOPE, RESULTING IN AN ERROR MESSAGE \"CHECK ENDOSCOPE CABLE CONNECTION TO VISION CART. ENDOSCOPE SELF-TEST. CLEAN CONNECTOR OR REPLACE ENDOSCOPE.\" WITH ERROR CODE 48221. AS A RESULT, THE QAP (QUALITY ASSURANCE PROCEDURE) TESTING WAS UNABLE TO BE PERFORMED. LOG REVIEW SHOWED MULTIPLE COMMUNICATION FAILURES WITH ERROR CODES 48221, 48229 AND 48406. EDT WAS PERFORMED AND FAILED TWICE. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE: THE ENDOSCOPE WAS FOUND EXHIBIT TIP DAMAGE. MECHANICAL INDENTATIONS WERE OBSERVED ON THE DISTAL TIP. THE ENDOSCOPE WAS TESTED AND PLACED ON AN IN-HOUSE SYSTEM FOR FUNCTIONAL TESTING FAILED DUE TO AN ELECTRICAL FAILURE LOW ADC LEVEL LE/RI. THE ENDOSCOPE WAS TESTED AND PLACED ON AN IN-HOUSE SYSTEM FOR FUNCTIONAL TESTING FAILED DUE TO AN ELECTRICAL FAILURE LOW UART LEVEL LE/RI OR DARK IMAGE. THE ENDOSCOPE WAS PLACED ON AN IN-HOUSE DIAGNOSTIC TESTER AND FOUND WITH LOCAL BUTTON CONTROLS NOT WORKING PROPERLY. THE ENDOSCOPE WAS TESTED AND PLACED ON IN-HOUSE SYSTEM FOR FUNCTIONAL TESTING AND FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL OR COMMUNICATION FAILURE. THE SYSTEM FAILED TO COMMUNICATE WITH THE TEMPERATURE SENSOR LOCATED ON THE CAMERA MODULE. THE ENDOSCOPE HAS A VCL VOLTAGE/CURRENT FAILURE AND VCH VOLTAGE/CURRENT FAILURE. THE ENDOSCOPE WAS TESTED AND PLACED ON A DIAGNOSTIC TESTER OR EQUIVALENT BUT FAILED FUNCTIONAL TESTING DUE TO AN ELECTRICAL FAILURE. THE DIAGNOSTIC TESTER RESULT EXHIBITED A VOLTAGE ISSUE DUE TO EXPECTED RANGE NOT BEING MET. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE." } ], "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": "11/07/2024" } ] }