{ "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": "2955842-2011-00205", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20110701", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110531", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other", "Foreign", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20110705", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20110701", "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": "20110624", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Unintended System Motion", "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "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": "20110701", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "70 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Aortic Dissection" ] } ], "distributor_city": "", "date_report": "20110719", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2147492", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20110531", "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": "2113457", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED FROM A FACILITY IN EUROPE THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE AND WHILE PERFORMING PARA-AORTIC LYMPH NODE DISSECTION, THE SURGEON POSITIONED THE RIGHT MASTER TOOL MANIPULATOR (MTMR) TOWARD THE UPPERMOST BOUNDARY OF HIS AVAILABLE MTM WORKSPACE. THE SURGEON REMOVED HIS FINGERS FROM THE MTMR WHILE HIS HEAD WAS IN THE SURGEON CONSOLE VIEWER (CONTRARY TO A WARNING IN THE LABELING), AND THE INSTRUMENT ASSOCIATED WITH THE MTMR DROPPED DOWN IN AN UNCONTROLLED MANNER, AND CUT THE PATIENT'S ABDOMINAL AORTA. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGERY AND THE PATIENT'S AORTA WAS REPAIRED BY PLACEMENT OF A STENT. THE PLANNED HYSTERECTOMY PROCEDURE WAS ALSO COMPLETED. AS OF THE DATE OF THIS REPORT, THE PATIENT IS REPORTED TO BE RECOVERING WITH NO COMPLICATIONS AND WAS DISCHARGED FROM THE HOSPITAL A WEEK AFTER THE OPERATION." }, { "mdr_text_key": "9219869", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MASTER TOOL MANIPULATOR (MTMR) WAS RETURNED TO ISI FOR EVALUATION. THE LINK 1 COVER WAS REMOVED TO VERIFY THE SPRING GUIDE FAILURE. WHEN THE COVER WAS REMOVED TO INSPECT THE DAMAGED SPRING GUIDE IT WAS NOTED THAT THE COUNTERBALANCE SPRING WAS PUSHING AGAINST THE INSIDE OF THE EXTERIOR COVER. WHEN THE COVER WAS REPLACED TO TAKE FORCE MEASUREMENTS, IT WAS NECESSARY TO COMPRESS THE SPRING SLIGHTLY TO TIGHTEN THE COVER MOUNTING SCREW. THE JOINT 2 (SHOULDER) SPRING GUIDE END FLANGE WAS OBSERVED TO HAVE CRACKED AWAY FROM THE REST OF THE SPRING GUIDE TUBE. THE END FLANGE REMAINS ATTACHED TO THE TUBE BY A SMALL THICKNESS OF MATERIAL AT THE END OF A VISIBLE TEAR IN THE PLASTIC. THE FRACTURE INITIATES AT A HIGH STRESS LOCATION NEAR A MOUNTING SCREW HEAD. THE SPRING EXTENSION RESULTING FROM THE CRACK WAS MEASURED WITH THE COVER REMOVED TO BE APPROXIMATELY 1.0 INCH +/-.1 INCH. VISUAL INSPECTION OF THE MTMR DID NOT REVEAL ANY OTHER ANOMALIES, ASIDE FROM THE CRACKED SPRING GUIDE, THAT WOULD ACCOUNT FOR LOSS IN GRAVITY COMPENSATION. THE ROOT CAUSE OF THE SPRING GUIDE FAILURE WAS A STRESS CONCENTRATION IN THE SPRING GUIDE WHERE THE FLANGE INTERSECTS THE THIN WALL OF THE TUBE IN A SHARP CORNER, COMBINED WITH CYCLIC LOADING OF THE SPRING GUIDE DUE TO MTM MOTION. THE STRESS CONCENTRATION RESULTED IN A CRACK THAT INITIATED AT THE HIGH STRESS LOCATION AND THEN SLOWLY PROPAGATED DUE TO CYCLIC LOADING AS THE FORCE FROM THE SPRING VARIED DURING USE OF THE MTM. STRESS WAS INDUCED IN THE FRACTURE LOCATION BY TENSILE LOADING ON THE GUIDE FROM SPRING COMPRESSION. STRESS NEAR THE END-FLANGE ON THE SPRING GUIDE RESTRAINING THE JOINT 2 COUNTERBALANCE SPRING WAS INCREASED BY THE CLAMP FORCE FROM THE SCREW HEAD THAT MOUNTS THE GUIDE TO THE MTM. THE REDUCTION IN GRAVITY COMPENSATION ON THIS MTMR IS DUE TO CRACKING NEAR THE JOINT 2 (SHOULDER) SPRING GUIDE END FLANGE. THE SPRING TUBE CONTAINS STRESS CONCENTRATIONS THAT ARE INHERENT TO THE PART GEOMETRY AND CYCLIC LOADING CAN CAUSE CRACKING AND GRADUAL TEARING OF THE PLASTIC PART. THE SEPARATION OF THE END FLANGE FROM THE TUBE AND RESULTING REDUCTION IN GRAVITY COMPENSATION IS LIKELY TO HAVE OCCURRED OVER THE COURSE OF SEVERAL MONTHS. INTUITIVE SURGICAL INITIATED A CORRECTIVE ACTION, 2955842-070111-002 C, ISSUED 7/1/2011, IN RELATION TO THIS SPRING COUNTERBALANCE SUBSYSTEM FAILURE OF THE MASTER TOOL MANIPULATOR THAT OCCURRED AT (B)(4) HOSPITAL. CORRECTION OF AFFECTED SYSTEMS HAS BEEN PERFORMED USING REINFORCING CAPS FOR THE RETENTION COMPONENT TO CORRECT THE PROBLEM WITH THE MTM SUBSYSTEM. AFFECTED MTM SPRING GUIDES WERE INSPECTED BY FIELD SERVICE ENGINEERS AND THOSE SPRING GUIDES HAVING NO CRACKS OR GAPS LESS THAN OR EQUAL TO 0.156 INCHES WERE RETROFITTED WITH REINFORCING CAPS IN THE FIELD. MTM'S CONTAINING SPRING GUIDES WITH GAPS LARGER THAN 0.156 INCHES WERE RETURNED THROUGH THE RMA PROCESS AND SPRING GUIDES WERE REPLACED PRIOR TO REINFORCING CAP INSTALLATION. ALL AFFECTED SYSTEMS HAVE BEEN RETROFITTED WITH THE REINFORCING CAPS. IN ADDITION, REEMPHASIS OF WARNINGS LISTED IN THE APPROVED USER MANUAL LABELING PROVIDED WITH EACH SYSTEM WARNING: ONCE IN FOLLOWING, THE SURGEON CONSOLE OPERATOR MUST NOT REMOVE HIS OR HER HANDS FROM THE MASTERS UNTIL REMOVING HIS OR HER HEAD FROM THE SURGEON CONSOLE VIEWER - THEREBY TAKING THE SYSTEM OUT OF FOLLOWING MODE. FAILURE TO DO SO MAY RESULT IN UNCONTROLLED MOVEMENT OF THE MASTERS, RESULTING IN SERIOUS HARM TO THE PATIENT. HAS BEEN PROVIDED TO ALL AFFECTED SITES." }, { "mdr_text_key": "9197608", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLER WHICH PROVIDES THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE INSTRUMENTS FOLLOW THE MOTIONS OF THE MTMS TO CONDUCT THE PROCEDURE, WHICH IS REFERRED TO AS FOLLOWING MODE. AS A SAFETY FEATURE, WHEN THE SURGEON REMOVES HIS HEAD FROM THE VIEWER PORTION OF THE SURGEON CONSOLE, THE INSTRUMENTS FREEZE IN POSITION. AN INVESTIGATION WAS CONDUCTED BY A LOCAL ISI FIELD SERVICE ENGINEER (FSE) FOLLOWING THE EVENT. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED EVENT; HOWEVER, THE FSE DID OBSERVE THAT THE MTMR SPRING GUIDE COMPONENT HAD FAILED. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTMR, AND THE ORIGINAL MTMR WAS RETURNED FOR ANALYSIS. THE SPRING GUIDE COMPONENT THAT WAS FOUND TO BE DAMAGED CONTAINS TWO SPRINGS, WHICH ARE PART OF THE GRAVITY COMPENSATION STRATEGY FOR THE SHOULDER AND ELBOW JOINTS OF THE MTM, WHICH ARE JOINTS THAT SUPPORT THE MTM HANDLES THAT THE SURGEON GRASPS WITH HIS OR HER FINGERS. THE SPRING GUIDE SECURES THE SPRINGS IN PLACE SUCH THAT MOTION OF THE JOINT COMPRESSES THE SPRINGS, PARTIALLY COUNTERACTING THE FORCE OF GRAVITY. THE SPRING COUNTERBALANCE IS SUPPLEMENTED BY A MOTORIZED GRAVITY COMPENSATION ALGORITHM. FOR THE COMFORT AND PRECISION OF THE SURGEON, THE SPRING AND MOTOR COMPENSATION IS TO REDUCE THE APPARENT WEIGHT OF THE ROBOTIC ARM AS PERCEIVED BY THE SURGEON. IT IS BELIEVED THAT IN INSTANCES WHERE THE SPRING GUIDE COMPONENT HAS FAILED, THE GRAVITY COMPENSATION SYSTEM CAN BE COMPROMISED, RESULTING IN A MAXIMUM IMBALANCE OF 0.6 LBS. THUS, IF CONTRARY TO THE BELOW WARNING INCLUDED IN THE PRODUCT LABELING, THE SURGEON RELEASES HIS GRIP ON AN MTM WHILE HIS OR HER HEAD IS IN THE VIEWER, THIS COMPONENT FAILURE MAY CAUSE THE MTM AND ITS ASSOCIATED INSTRUMENT, TO MOVE IN AN UNCONTROLLED MANNER. IF THE SURGEON COMPLIES WITH THE LABEL WARNING BELOW, NO UNCONTROLLED MOTION SHOULD OCCUR. THE DA VINCI SI USER MANUAL WARNING STATES: WARNING: ONCE IN FOLLOWING, THE SURGEON CONSOLE OPERATOR MUST NOT REMOVE HIS OR HER HANDS FROM THE MASTERS UNTIL REMOVING HIS OR HER HEAD FROM THE SURGEON CONSOLE VIEWER - THEREBY TAKING THE SYSTEM OUT OF FOLLOWING MODE. FAILURE TO DO SO MAY RESULT IN UNCONTROLLED MOVEMENT OF THE MASTERS, RESULTING IN SERIOUS HARM TO THE PATIENT. A CORRECTIVE ACTION IS UNDERWAY TO INSTALL METAL REINFORCING CAPS FOR THE RETENTION COMPONENT IN THE MTMS ON ALL IS3000 SYSTEMS TO PREVENT THE FAILURE OF THE SPRING GUIDE COMPONENT. ADDITIONAL INFORMATION CONCERNING THE CORRECTIVE ACTION IS PROVIDED WITH THE FEDEX COPY OF THIS REPORT. (B)(4)." } ], "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": "08/08/2011" } ] }