{ "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": "2955842-2013-00491", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130214", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130122", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130215", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "65892", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130214", "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 A60P4", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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 Operates Differently Than Expected" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20130214", "sequence_number_treatment": [ "DA VINCI SI SURGICAL SYSTEM AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20130122", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2962573", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130122", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "3328559", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN ARTICLE ENTITLED PATIENT SAYS BROKEN DA VINCI ROBOT CAUSED A PERFORATED COLON THAT LED TO DISTURBING GI COMPLICATIONS PUBLISHED ON (B)(4) 2011 BY (B)(4) WAS PROVIDED TO INTUITIVE SURGICAL ON (B)(4) 2013. THE ARTICLE ALLEGES THAT DURING THE PATIENT'S PROSTATECTOMY PROCEDURE IN JANUARY 2007 THE SYSTEM MALFUNCTIONED AND THE SURGICAL PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. THE PATIENT WAS REPORTED TO HAVE GONE INTO RECOVERY IN GOOD CONDITION, HOWEVER, ON HIS WAY HOME FROM THE HOSPITAL HE SENSED THAT THE PROSTATECTOMY HAD GONE WRONG. THE ARTICLE ALLEGED THAT THE PATIENT BEGAN URINATING OUT OF HIS RECTUM AND NOTICED THAT DARK MATTER WAS COMING OUT OF HIS PENIS." }, { "mdr_text_key": "10541531", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2013 THE PHYSICIAN'S OFFICE WAS CONTACTED TO REQUEST ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT, HOWEVER, AS OF THE DATE OF THIS REPORT THE SITE WAS NOT WILLING TO PROVIDE FURTHER INFORMATION. A REVIEW OF SYSTEM LOGS FOR THE DA VINCI SURGICAL SYSTEM USED IN THE PROCEDURE DID NOT PRODUCE OR CONFIRM ANY INFORMATION FOR THE GIVEN SYSTEM AT THE TIME PERIOD INDICATED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MDR WILL BE SUBMITTED." } ], "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": "" } ] }