{ "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": "N", "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": "2955842-2010-00031", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20100129", "manufacturer_address_2": "", "pma_pmn_number": "K012833", "date_of_event": "20091230", "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": "20100201", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100129", "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": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20100111", "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": [ "Air Leak", "Sticking", "Unintended Movement" ], "reporter_state_code": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20100129", "sequence_number_treatment": [ "DA VINCI S SYST, INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "68 YR", "patient_sex": "", "patient_weight": "95", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Perforation of Vessels" ] } ], "distributor_city": "", "date_report": "20091230", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1590517", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20091230", "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": "17018867", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED, THAT WHILE MOBILIZING THE LEFT INTERNAL MAMMARY ARTERY DURING A DA VINCI S CABG PROCEDURE, THE MICRO BIPOLAR FORCEPS (MBF) INSTRUMENT JUMPED FORWARD AND PUNCTURED THE PATIENT'S ARTERY. THE DAMAGED SECTION OF THE ARTERY WAS TRANSECTED AND THE HEALTHY PORTION OF THE ARTERY WAS USED TO COMPLETE THE BYPASS. IT WAS ALSO REPORTED THAT THROUGHOUT THE CASE, PNEUMO WAS ESTABLISHED AND LOST SEVERAL TIMES. THE ISI REPRESENTATIVE PRESENT DURING THE PROCEDURE INDICATED THAT PRIOR TO THE MBF INSTRUMENT JUMP, THE SURGEON NOTED THAT WHEN THE MASTER TOOL MANIPULATOR WAS MOVED, THE INSTRUMENT FELT STUCK AND THEN MOVED. IT IS BELIEVED THAT THE SURGEON CAUGHT THE MBF INSTRUMENT IN THE PATIENT'S RIB. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES OR PATIENT HARM." }, { "mdr_text_key": "17288340", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B) (4) - THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). THE FSE FOUND NO ERROR CODES ASSOCIATED WITH THE REPORTED MALFUNCTION WHEN REVIEWING THE SYSTEM ERROR LOGS AND WAS UNABLE AND TO REPLICATE THE REPORTED FAILURE MODE. FUNCTIONAL TESTING OF THE SYSTEM REVEALED THAT THE PATIENT SIDE MANIPULATOR (PSM) ON WHICH THE MICRO BIPOLAR FORCEPS INSTRUMENT WAS INSTALLED FUNCTIONED NORMALLY, HOWEVER, AN AXIS OF THE PSM WAS FOUND TO BE OUT OF TOLERANCE. ALTHOUGH THE PSM AXIS WAS FOUND TO BE OUT OF TOLERANCE, IT IS HIGHLY UNLIKELY THAT THE FAILURE MODE IN ITSELF WOULD HAVE CAUSED OR CONTRIBUTED TO THE INSTRUMENT JUMP EXPERIENCED BY THE CUSTOMER. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE AFFECTED PSM WAS REPLACED TO REPAIR THE SYSTEM. A DVD OF THE RECORDED PROCEDURE WAS RETURNED TO ISI FOR REVIEW. ENGINEERING OBSERVED A SUDDEN MOTION OF THE INSERTION AXIS OF THE PSM CAUSING THE INSTRUMENT TO PIERCE THE PATIENT'S ARTERY. THE DISTANCE TRAVELED APPEARED TO BE LARGER THAN 1CM. ENGINEERING ALSO OBSERVED OTHER INSTANCES WHERE THE INSTRUMENT TIP APPEARED TO MAKE SUDDEN MOVEMENTS, HOWEVER, THEY WERE OF A SMALLER MAGNITUDE THAN THE MOVEMENT THAT CAUSED DAMAGE TO THE PATIENT'S ARTERY. ENGINEERING CONCLUDED THAT THE ROOT CAUSE OF THE INSTRUMENT MOVEMENT WAS DUE TO MOTION BEING IMPEDED BY A LARGE AMOUNT OF STATIC FRICTION. THE SOURCE OF THE FRICTION IS UNKNOWN. SOME OF THE POSSIBLE SOURCES ARE STERILE DRAPE, A BENT INSTRUMENT, OR A BENT CANNULA. IN THIS CASE, THE SURGEON WOULD MOVE THE MASTER TOOL MANIPULATOR (MTM) AND THE INSTRUMENT WOULD NOT MOVE INITIALLY DUE TO THE FRICTION, HOWEVER, ONCE THE SURGEON MOVED FAR ENOUGH FOR THE INSTRUMENT TO OVERCOME THE FRICTION, THE INSTRUMENT COULD MAKE A QUICK JUMP TO CATCH UP WITH THE MTM. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLER WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENT AND ENDOSCOPE INSIDE THE PATIENT. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE, HOWEVER, THE AXIS OUT OF TOLERANCE ISSUE WAS CONFIRMED AND IT WAS DETERMINED THAT THE AXIS POTENTIOMETER AND MOTOR/ENCODER HAD MALFUNCTIONED. AS OF (B) (6) 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": "" } ] }