{ "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": "I", "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": "2955842-2016-00880", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20161209", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20161114", "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 REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20161209", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "808624", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20161209", "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 A60P9B", "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": [ "Use of Device Problem", "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": "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": "20161209", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20161114", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6159596", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20161114", "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": "62115677", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS DETERMINED THAT THE CAUSE OF THE PSM 2 MOVING ON ITS OWN WAS DUE TO USER-ERROR. THE SURGICAL STAFF REPORTEDLY EXCHANGED AN INSTRUMENT WHILE THE SURGEON'S HEAD WAS IN THE HRSV. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE PERMANENT CAUTERY HOOK INSTRUMENT OCCURRED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. DURING THE SURGICAL PROCEDURE, TWO SEPARATE SYSTEM ERROR CODE 23075 OCCURRED APPROXIMATELY 9 MINUTES APART FROM EACH OTHER. A SYSTEM ERROR CODE 23075 IS GENERATED WITH THE SYSTEM DETECTS THAT CONDITIONS CONSISTENT WITH THE MTM MOVING IN FOLLOWING WITHOUT THE SURGEON'S HANDS ON THE HANDLE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED A LIVER INJURY THAT WAS CAUTERIZED BY THE SURGEON. HOWEVER, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CAN BE ATTRIBUTED TO USER-ERROR. THERE IS NO INDICATION THAT AN ISI DEVICE MALFUNCTIONED IN A WAY THAT COULD CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "62115678", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) 2 ALLEGEDLY MOVED ON ITS OWN WITH A PERMANENT CAUTERY HOOK INSTRUMENT INSTALLED. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE EVENT REPORTEDLY OCCURRED WHILE THE SURGEON WAS WAITING FOR INSTRUMENT REMOVAL. AS A RESULT, THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT INJURED THE PATIENT'S LIVER AND BLEEDING ENSUED. AFTER THE SURGEON CONTROLLED THE BLEEDING USING CAUTERY WITH THE SAME PERMANENT CAUTERY HOOK INSTRUMENT, THE SURGICAL STAFF PROCEEDED WITH THE SURGICAL PROCEDURE. WHEN THE EVENT OCCURRED, THE INITIAL REPORTER AND SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR SUPPORT. THE TSE INFORMED THE INITIAL REPORTER OF THE POSSIBLE CAUSES OF THE PSM DRIFTING. THE INITIAL REPORTER WAS GOING TO FOLLOW UP WITH THE SURGEON TO ENSURE HE REMOVES HIS HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV) BEFORE RELEASING HIS GRIPS ON THE MASTER TOOL MANIPULATORS (MTMS). ON 12/05/2016, ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE INITIAL REPORTER WAS PRESENT DURING THE UNRECORDED SURGICAL PROCEDURE. THE INITIAL REPORTER INDICATED THAT THE EVENT OCCURRED WHILE THE SURGICAL STAFF WAS ATTEMPTING TO EXCHANGE INSTRUMENTS AND THE SURGEON'S HEAD WAS STILL IN THE HRSV. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS REPORTEDLY NOT GRASPING THE MTMS. ACCORDING TO THE DA VINCI SURGICAL SYSTEM USER MANUAL, THE FOLLOWING IS CAUTION IS NOTED: 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. THE INITIAL REPORTER DISCUSSED THE REPORTED EVENT WITH THE SURGEON AND IT WAS CONCLUDED THAT SURGEON ERROR LIKELY CAUSED THE INTRA-OPERATIVE COMPLICATION SINCE HE KEPT HIS HEAD IN THE HRSV WHILE THE SURGICAL STAFF WAS EXCHANGING INSTRUMENTS. WHEN THE EVENT OCCURRED, PSM 2 ALLEGEDLY DRIFTED AND THE PERMANENT CAUTERY HOOK INSTRUMENT INSTALLED IN PMS 2 PUNCTURED THE PATIENT'S LIVER. THE SURGEON WAS ABLE TO CONTROL THE BLEEDING THAT ENSUED BY CAUTERIZING THE INJURY WITH THE SAME PERMANENT CAUTERY HOOK INSTRUMENT THAT PUNCTURED THE LIVER. THE INITIAL REPORTER STATED THAT THE BLEEDING WAS MINIMAL AND NO BLOOD TRANSFUSIONS WERE ADMINISTERED TO HER KNOWLEDGE. THE SURGEON SUCCESSFULLY COMPLETED THE SURGICAL PROCEDURE AND NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ALLEGED PSM DRIFTING ISSUE." } ], "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": "" } ] }