{ "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": "2955842-2022-15183", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20221111", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20221011", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20221111", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210128", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1284825", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20221111", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380941-40", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20221019", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Output Problem", "Output Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/30/2022", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250817", "health_professional": "Y", "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": "20221111", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20221011", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15777799", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221011", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "303572715", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE VISION WAS LOST. THEY ATTEMPTED TO RECONNECT THE CAMERA TO THE ENDOSCOPE CONTROLLER (EC), BUT THE CAMERA HAD A SELF-TEST FAILURE, AND THE COLOR BAR WAS DISPLAYED. THEY REPLACED THE CAMERA WITH A BACKUP ONE, BUT ALL THE AVAILABLE CAMERAS HAD THE SAME SYMPTOM. LASTLY, THEY REBOOTED THE SYSTEM AND CLEANED THE CAMERA CONNECTOR; HOWEVER, THE ISSUE PERSISTED. THE CUSTOMER ELECTED TO CONVERT TO LAPAROSCOPIC PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP ON 19-OCT-2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CAMERAS WERE INSPECTED PRIOR TO USE WITH NO ABNORMALITY. DURING THE PROCEDURE, THE VISION LOSS OCCURRED ON BOTH OF THE SURGEON SIDE CONSOLE (SSC) AND VISION SIDE CART (VSC). INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION." }, { "mdr_text_key": "303572716", "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 COMPLAINT. THERE WAS VISION LOSS DURING THE PROCEDURE. THE CUSTOMER REPLACED THE CAMERA, BUT THE ISSUE WAS NOT RESOLVED. AFTER COMPLETING THE LAPAROSCOPIC PROCEDURE, THE FSE PERFORMED CAMERA TEST, BUT THE SP CAMERAS WORKED NORMALLY. THE FSE REPLACED THE ENDOSCOPE CONTROLLER (EC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED OPERATED WITHOUT ERROR AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE EC INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION COULD NOT REPLICATE THE CUSTOMER REPORTED COMPLAINT ¿ERROR 307 AND 48308¿. HOWEVER, THE ERROR/FAULT WAS CONFIRMED VIA ERROR LOGS/SYSTEM LOGS. PROCEDURE ERROR LOGS SHOWED THREE OCCURRENCES OF ERROR 307 DURING THE 60 DAYS PRIOR TO THIS RMA'S CREATION DATE. THE LOGS ALSO SHOWED THREE OCCURRENCES OF ERROR 48308 INDICATING ISSUES WITH THE VISION CAMERA ALGORITHM IN THE EC. THE EC WAS INSTALLED WITH A PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM WHICH LAUNCHED IN MAINTENANCE MODE TO PROGRAM SOFTWARE, THEN POWER CYCLED 10 TIMES WITHOUT ERROR. THE SYSTEM THEN LAUNCHED IN NORMAL MODE AT WHICH TIME IMAGE QUALITY WAS CONFIRMED TO BE CLEAR, CRISP, AND FREE OF NOISE. VERIFICATION VIA PROCEDURE LOGS CONFIRMS THE OCCURRENCE OF THE ERROR FAULT ON THE REPORTED EVENT DATE (B)(6) 2022 ON SYSTEM SP0161 MATCHING THE DOCUMENTED EVENT DETAILS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO VISION LOSS." }, { "mdr_text_key": "332276493", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CAMERAS USED DURING THE PROCEDURE AND INVESTIGATION RESULTS ARE THE FOLLOWINGS: BOTH CAMERA (SERIAL NUMBER (B)(6)) AND CAMERA (SERIAL NUMBER (B)(6)) WERE PLACED ON THE IN-HOUSE SYSTEM AND SUCCESSFULLY PASSED THE QAP TEST (QUALITY ASSURANCE PROCEDURE). THEY PASSED THE ENDOSCOPE DIAGNOSTIC TEST. REVIEW OF THE ERROR LOGS FOUND THAT THE CAMERA GENERATED ERROR CODES 48221, 48406, 48225, 48229, 48216." }, { "mdr_text_key": "332276494", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/30/2022" } ] }