{ "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": "2955842-2025-11682", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250327", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250303", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20250327", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240318", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2532905", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250327", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE 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": "380601-50", "catalog_number": "380601", "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": "00886874114605", "udi_public": "(01)00886874114605", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Poor Quality Image", "Poor Quality Image" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/02/2025;05/02/2025;08/19/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20251027", "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": "20250327", "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": "20250303", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21706565", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250303", "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": "371585717", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ENDOSCOPIC CONTROLLER (EC) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE WAS NOT CONFIRMED AND NOT REPLICATED. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED FAILURE. SYSTEM CAME UP WITH NO ERRORS AND GOOD VIDEO ON BOTH EYES WITH NO ISSUE. THE EC IS WORKED AS NORMAL." }, { "mdr_text_key": "371585718", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "369140834", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE PROCEDURE WAS A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH EXTRAPERITONEAL LYMPHADENECTOMY. THE ENDOSCOPIC CONTROLLER (EC) WAS RECEIVED FOR FAILURE ANALYSIS. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED FAILURE. THE EC WORKED AS NORMAL. AN ENDOSCOPIC CAMERA WAS RECEIVED FOR FAILURE ANALYSIS, AND DURING THE FIELD LOG REVIEW MULTIPLE ERRORS WERE IDENTIFIED AND CONFIRMED BY THE SCOPE ERROR FINDER. HOWEVER, THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE REPLICATED. THE ENDOSCOPE PASSED ENGAGEMENT AND RECOGNITION ON MULTIPLE ATTEMPTS, SUCCESSFULLY CALIBRATED BY RECOGNIZING VARIOUS TARGETS AND IMAGES AT DIFFERENT DISTANCES, AND ALL BUTTON FUNCTIONS AND THE FIREFLY TEST PERFORMED WITHOUT ISSUE. IN-HOUSE TESTING USING EDT REVEALED THAT THE CAMERA FAILED BOTH THE FIRST AND SECOND TESTS. SPECIFICALLY, THE CAMERA FAILED ON ILLUMINATION AND IMAGE CAPTURE ON THE RIGHT SIDE, WHERE A BLURRY SECTION APPEARED IN THE LOWER PART OF THE VIDEO IMAGE¿AS WELL AS ON TIP ARTICULATION, WHICH DISPLAYED A HORIZONTAL LINE ACROSS THE IMAGE, AND ON THE REPEATER COMMUNICATION TEST DURING THE SECOND EDT TRIAL. ADDITIONALLY, THE CAMERA FAILED THE PROXIMAL LEAK TEST; ALTHOUGH NO BUBBLES WERE OBSERVED, IT LOST THE APPLIED PRESSURE. THE SNORKEL, HOWEVER, WAS INSPECTED AND FOUND TO HAVE NO ISSUES. ANOTHER ENDOSCOPIC CAMERA USED HAS BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT." }, { "mdr_text_key": "382313611", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "382313612", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPRODUCED THE ISSUE AND REPLACED THE ENDOSCOPIC CONTROLLER. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE ENDOSCOPIC CONTROLLER (EC) FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE WAS NOT CONFIRMED AND NOT REPLICATED. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED FAILURE. THE UNIT WAS INSTALLED AND TESTED INTO A GOLDEN PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM AND RAN A VIDEO TEST, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR. THE SYSTEM CAME UP WITH NO ERRORS AND GOOD VIDEO ON BOTH EYES WITH NO ISSUE. THE EC IS WORKED AS NORMAL. COULD NOT REPLICATE SEVERAL ENDOSCOPE PROBLEMS. THE FIRST ENDOSCOPIC CAMERA WAS RECEIVED FOR FAILURE ANALYSIS, AND DURING THE FIELD LOG REVIEW THE INSTRUMENT WAS FOUND TO HAVE 1 CAMERA TEMPERATURE SENSOR FAILURE ERROR CODE, WHICH WAS NOT REPLICATED DURING IN-HOUSE TESTING. HOWEVER, THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE REPLICATED. THE ENDOSCOPE PASSED SELF-TEST WITH NO ISSUES. NO ERROR MESSAGE WAS OBSERVED DURING IN-HOUSE TESTING. THE CAMERA PASSED ALL THE QAP (QUALITY ASSURANCE PROCEDURE) TESTING. EDT WAS PERFORMED AND PASSED. THE DISTAL AND PROXIMAL LEAK TESTS WERE PERFORMED AND PASSED. ADDITIONALLY, FAILURE ANALYSIS FOUND THE SECONDARY FAILURE OF SELF-TEST FAILURE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. BASED ON LOG REVIEW, THE INSTRUMENT WAS FOUND TO HAVE MULTIPLE SELF-TEST FAILURES WITH ERROR CODES, WHICH WERE NOT REPLICATED DURING IN-HOUSE TESTING. THE SECOND ENDOSCOPIC CAMERA WAS RECEIVED FOR FAILURE ANALYSIS, AND DURING THE FIELD LOG REVIEW MULTIPLE ERRORS WERE IDENTIFIED AND CONFIRMED BY THE SCOPE ERROR FINDER. HOWEVER, THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE REPLICATED. IN-HOUSE TESTING USING EDT REVEALED THAT THE CAMERA FAILED BOTH THE FIRST AND SECOND TESTS. SPECIFICALLY, THE CAMERA FAILED ON ILLUMINATION AND IMAGE CAPTURE ON THE RIGHT SIDE¿WHERE A BLURRY SECTION APPEARED IN THE LOWER PART OF THE VIDEO IMAGE¿AS WELL AS ON TIP ARTICULATION, WHICH DISPLAYED A HORIZONTAL LINE ACROSS THE IMAGE, AND ON THE REPEATER COMMUNICATION TEST DURING THE SECOND EDT TRIAL. ADDITIONALLY, THE CAMERA FAILED THE PROXIMAL LEAK TEST; ALTHOUGH NO BUBBLES WERE OBSERVED, IT LOST THE APPLIED PRESSURE. THE SNORKEL, HOWEVER, WAS INSPECTED AND FOUND TO HAVE NO ISSUES. THE ENDOSCOPE PASSED ENGAGEMENT AND RECOGNITION ON MULTIPLE ATTEMPTS, SUCCESSFULLY CALIBRATED BY RECOGNIZING VARIOUS TARGETS AND IMAGES AT DIFFERENT DISTANCES, AND ALL BUTTON FUNCTIONS AND THE FIREFLY TEST PERFORMED WITHOUT ISSUE. ADDITIONAL FAILURE ANALYSIS WAS PERFORMED ON BOTH ENDOSCOPES. THE INVESTIGATION INTO THE FAILED SELF-TEST SYMPTOM ON THE SP ENDOSCOPE IDENTIFIED THAT THE ISSUE WAS PRIMARILY RELATED TO THE CONNECTION BETWEEN THE QUADRAX CONNECTOR AND THE SENSOR MODULE." }, { "mdr_text_key": "366774374", "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 SURGEON CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT DEGRADED IMAGE QUALITY FROM THE ENDOSCOPE. THE TSE RECOMMENDED USING A BACKUP ENDOSCOPE, WHICH TEMPORARILY RESOLVED THE ISSUE, ALLOWING THE SYSTEM TO BECOME OPERATIONAL. SURGERY CONTINUED WITH THR NEW ENDOSCOPE, BUT THIS ENDOSCOPE EXHIBITED SIMILAR ISSUES AND EVENTUALLY STOPPED WORKING ENTIRELY. THE CUSTOMER DID NOT HAVE AN ADDITIONAL SCOPE AVAILABLE, RESULTING IN THE PROCEDURE BEING CONVERTED TO OPEN SURGERY." }, { "mdr_text_key": "366774375", "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 REPRODUCED THE ISSUE AND REPLACED THE ENDOSCOPE CONTROLLER. 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": "04/29/2025;05/28/2025;09/12/2025" } ] }