{ "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": "2955842-2011-00133", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20110429", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20110330", "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": [ "Foreign", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20110429", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20110429", "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": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20110429", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "52 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Blood Loss", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20110330", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2072781", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20110330", "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": "9033927", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ADDITIONAL INFORMATION WAS PROVIDED BY THE CONSOLE SURGEON, WHO INDICATED THAT AN INSTRUMENT MAY HAVE TOUCHED THE PATIENT'S BOWEL DURING AN INSTRUMENT EXCHANGE, HOWEVER, NO ISSUES WERE OBSERVED DURING THE EXCHANGE. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED. NO INFORMATION HAS BEEN RECEIVED WHICH SUGGESTS THAT THE DA VINCI S SURGICAL SYSTEM MALFUNCTIONED IN A WAY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. INTUITIVE SURGICAL CONCLUDED THAT THE PATIENT INJURY WAS UNRELATED TO THE PERFORMANCE OF THE DA VINCI S SURGICAL SYSTEM. THE DA VINCI S SURGICAL SYSTEM USER'S MANUAL SPECIFICALLY STATES: CAUTION: ENSURE ALL INSTALLED INSTRUMENTS ARE VISIBLE IN THE SURGEON CONSOLE VIEW BEFORE PROCEEDING TO PREVENT INADVERTENT HARM TO THE PATIENT. WARNING: THE INSTRUMENT MAY NOT BE IMMEDIATELY VISIBLE WHEN BEING MOVED FROM THE CANNULA INTO THE PATIENT. USE APPROPRIATE CAUTION WHEN MANUALLY INSERTING INSTRUMENTS INTO THE PATIENT. CAUTION: REMOVAL OF INSTRUMENTS DURING A PROCEDURE SHOULD BE DONE VERY CAREFULLY AND ONLY WITH THE KNOWLEDGE OF AND FULL VIEW OF THE SURGEON CONSOLE OPERATOR. PRIOR TO INSTRUMENT REMOVAL, THE SURGEON CONSOLE OPERATOR SHOULD DO THE FOLLOWING: ENSURE THE INSTRUMENT IS FREE AND CLEAR OF ANY PATIENT ANATOMY" }, { "mdr_text_key": "1850946", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE A VERY SMALL AMOUNT OF BLOOD WAS OBSERVED ON THE PATIENT'S DESCENDING COLON, AROUND THE SIGMOID. ANOTHER SURGEON WAS BROUGHT IN TO ASSESS THE ISSUE AND CONFIRMED THAT THE PATIENT'S BOWEL HAD BEEN PERFORATED. SINCE THE DAMAGE WAS LOCATED ON THE UNDERSIDE OF THE PATIENT'S BOWEL, VISIBILITY WAS LIMITED AND THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO REPAIR THE DAMAGED BOWEL AND COMPLETE THE PLANNED PROCEDURE. POSTOPERATIVELY, 4 UNITS OF BLOOD WERE GIVEN TO THE PATIENT TO HELP WITH THEIR BOWEL RECOVERY AND BLEEDING FROM THE DEEP DORSAL VEIN COMPLEX. IT WAS REPORTED THAT THE PATIENT IS IN STABLE CONDITION." } ], "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": "" } ] }