{ "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": "2026-09-22", "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": "2955842-2011-00278", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20110826", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110804", "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": [ "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20110829", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20110826", "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 A6.0P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20110812", "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": [ "Failure to Advance" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20110826", "sequence_number_treatment": [ "DA VINCI SI SURGICAL SYSTEM INSTS & ACCS" ], "sequence_number_outcome": [ "Life Threatening" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20110804", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2224637", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20110804", "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": "2265764", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, AN INSTRUMENT WOULD NOT ADVANCE ON ITS OWN SO THE INSTRUMENT ARM CLUTCH BUTTON WAS PRESSED TO MANUALLY ADVANCE THE INSTRUMENT. WHEN THE BUTTON WAS PRESSED, THE INSTRUMENT ADVANCED INTO THE PATIENT'S PERINEUM AND NICKED A SUPERFICIAL VEIN. THE SURGICAL STAFF REMOVED ALL OF THE INSTRUMENTS AND CONVERTED TO OPEN SURGICAL TECHNIQUES TO ADDRESS THE PATIENT INJURY AND COMPLETE THE PLANNED PROCEDURE. THE HOSPITAL CONFIRMED THAT THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE INCIDENT." }, { "mdr_text_key": "9259538", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INVESTIGATION WAS CONDUCTED BY A FIELD SERVICE ENGINEER, WHO REVIEWED THE SYSTEM LOGS AND DID NOT FIND ANY ERRORS ASSOCIATED WITH THE AFFECTED PATIENT SIDE MANIPULATOR (PSM) ARM. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. AS A PRECAUTION, THE AFFECTED PSM WAS REPLACED. THE PSM WAS RETURNED TO INTUITIVE SURGICAL FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING OBSERVED THAT THE LINEAR BEARINGS ON LINK-5 ARE NOT ALIGNING, THUS CAUSING EXCESSIVE FRICTION AND BINDING ON THE AXIS-3 INSERTION DRIVE. AS OF (B)(6), 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL." } ], "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": "" } ] }