{ "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": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2007-00363", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20070928", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20070824", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20071009", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20070928", "brand_name": "DA VINCI S 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": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P2", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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 Remains Activated", "Use of Device Problem" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20070928", "sequence_number_treatment": [ "DA VINCI S SURGICAL SYSTEM INSTRUMENTS", " ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dural Tear", "Surgical procedure, additional" ] } ], "distributor_city": "", "date_report": "20070928", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "921167", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20070828", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Inspection" ], "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": "7853729", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INVESTIGATION WAS CONDUCTED BY AN ISI FIELD SERVICE ENGINEER (FSE). THE ISI FSE PERFORMED SYSTEM VERIFICATION TESTS, RESULTING IN THE SYSTEM PASSING IN ACCORDANCE TO ISI STANDARDS. NO TROUBLE WAS FOUND WITH THE SYSTEM, AND THE ISI FSE WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED COMPLAINT. ADDITIONAL INVESTIGATION PERFORMED BY AN ISI SYSTEMS ANALYST CONCLUDED THAT IT IS HIGHLY PROBABLE THAT THE SURGEON INADVERTENTLY BUMPED OR MOVED THE MASTER AFTER HE REMOVED HIS HANDS FROM THE CONTROL LOOPS, OR LET GO OF THE MASTER HANDLE WITH SOME RESIDUAL VELOCITY. BECAUSE, HIS HEAD WAS STILL DETECTED BY THE VIEWER HEAD SENSORS, THE SYSTEM RESPONDED TO THE MASTER MOTION APPROPRIATELY BY MOVING THE SLAVE IN KIND. AS OF SEPTEMBER 27, 2007, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL." }, { "mdr_text_key": "699896", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ISI RECEIVED A REPORT THAT DURING A DA VINCI TOTAL HYSTERECTOMY PROCEDURE, THE SURGEON REMOVED HIS HANDS FROM THE MASTER TOOL MANIPULATOR (MTM); AT THE SAME TIME, ALL EVIDENCE INDICATES THE SURGEON DID NOT REMOVE HIS HEAD FROM THE SURGEON'S CONSOLE, WITH THE RESULT THAT THE PT SIDE MANIPULATOR (\"PSM\") REMAINED ENGAGED. UPON REMOVAL OF THE SURGEON'S HANDS FROM THE MTM, THE PSM DROPPED SHARPLY, CAUSING THE SCISSORS INSTRUMENT, WHICH WAS INSTALLED ON THE PSM TO INADVERTENTLY PIERCE THE PT'S UTERER. THE UTERER WAS, THEREAFTER, STENTED AND SUCCESSFULLY SUTURED BY A UROLOGIST." } ], "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": "" } ] }