{ "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": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2010-00481", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20101105", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100826", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20101108", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20101105", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS3000 A6.0P4", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Device Inoperable", "Device Displays Incorrect Message" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20101105", "sequence_number_treatment": [ "DA VINCI SI SYS, INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20100826", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1891889", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20100826", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Repair" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "19513546", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING FOUND THE CAMERA CABLE HAD A BAD LEFT EYE CHANNEL. THE CAMERA CABLE CONNECTS THE CAMERA TO THE SYSTEM'S VISION CART, WHICH THEN TRANSMITS THE IMAGE TO THE SURGEON SIDE CONSOLE. THE SYSTEM WAS REPAIRED BY REPLACING THE DEFECTIVE CAMERA CABLE. AS OF NOVEMBER 4, 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL." }, { "mdr_text_key": "19270480", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SITE RECEIVED A VISION SYSTEM ERROR. THE ISI REPRESENTATIVE ON SITE BEGAN TO TROUBLESHOOT AND FOUND THE LEFT EYE ON THE SURGEON SIDE CONSOLE WAS NOT WORKING. THE SURGEON AND OR STAFF WERE NOTIFIED OF THE SYSTEM STATUS; HOWEVER, THE SURGEON DECIDED TO PERFORM THE CASE WITH ONE EYE WORKING IN 2D VISION. DURING THE PROCEDURE THE PATIENT'S URETERAL WAS INJURED AND A UROLOGIST WAS CALLED IN TO PERFORM THE REPAIR AND PLACE A STENT. AT THIS TIME THE CASE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO REPAIR THE PATIENT'S URETERAL AND COMPLETE THE PLANNED PROCEDURE. THE PATIENT WAS REQUIRED TO STAY IN THE HOSPITAL AN ADDITIONAL 24-48 HOURS DUE TO THE OPEN INCISION AS WELL AS THE STENT REMOVAL. ON (B)(4) 2010, INTUITIVE SURGICAL RECEIVED MAUDE EVENT REPORT (B)(4) FOR THIS EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }