{ "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": "2955842-2012-00177", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20120420", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120323", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120423", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120420", "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": "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": [ "Device Displays Incorrect Message", "Difficult to Open or Close", "Mechanical Jam" ], "reporter_state_code": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20120420", "sequence_number_treatment": [ "DA VINCI SI SYSTEM, INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20120323", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2543963", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120323", "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": "2606205", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI PULMONARY LOBECTOMY PROCEDURE, THE PATIENT'S PULMONARY ARTERY WAS LACERATED, REQUIRING HEMOSTASIS OF THE AFFECTED VESSEL USING A CADIERE FORCEPS INSTRUMENT TO ALLOW FOR COMPLETION OF THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. AFTER OBTAINING ADEQUATE EXPOSURE, THE SITE ATTEMPTED TO MANUALLY OPEN THE GRIPS ON THE CADIERE FORCEPS INSTRUMENT USING SEVERAL DIFFERENT ALLEN WRENCHES, HOWEVER, THE INSTRUMENT GRIPS WOULD NOT RELEASE. THE SITE THEN ATTEMPTED TO RELEASE THE INSTRUMENT USING THE MASTER TOOL MANIPULORS (MTM), HOWEVER, THE ERROR MESSAGE UNABLE TO ALIGN MASTERS WAS OBSERVED. UNABLE TO RESOLVE THE ISSUE, THE SITE CONTACTED ISI TECHNICAL SUPPORT ENGINEERING (TSE) FOR TROUBLESHOOTING ASSISTANCE. AFTER PERFORMING AN EMERGENCY STOP/RECOVER OF THE SYSTEM, THE GRIPS ON THE CADIERE FORCEPS INSTRUMENT OPENED. NO OTHER INFORMATION CONCERNING THE REPORTED EVENT WAS PROVIDED." }, { "mdr_text_key": "9817279", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, ISI'S SUPERVISOR OF TECHNICAL SUPPORT ENGINEERING CONTACTED THE SURGEON, DR. (B)(6) AT (B)(6) TO DISCUSS THE DIFFICULTIES EXPERIENCED WHILE ATTEMPTING TO RELEASE THE CADIERE FORCEPS INSTRUMENT. DR. (B)(6) INDICATED THAT AFTER DAMAGE TO THE PATIENT'S PULMONARY ARTERY OCCURRED, HE USED A CADIERE FORCEPS INSTRUMENT TO CLAMP DOWN ON THE VESSEL TO STOP THE BLOOD FLOW TO ALLOW FOR CONVERSION OF THE PROCEDURE TO OPEN. DR. (B)(6) MADE THE DECISION TO RELEASE THE CADIERE FORCEPS INSTRUMENT FROM THE PATIENT BEDSIDE, INSTEAD OF FROM THE SURGEON SIDE CART. HOWEVER WHEN THE SURGICAL STAFF ATTEMPTED TO USE AN ALLEN WRENCH TO RELEASE THE INSTRUMENT, THE INSTRUMENT WOULD NOT RELEASE. THE TSE REITERATED THAT THE INSTRUCTIONS IN THE SYSTEM USER MANUAL STATES THAT THE EMERGENCY GRIP RELEASE MECHANISM FACILITATES REMOVAL OF AN INSTRUMENT IN THE EVENT OF A SYSTEM FAULT. DR. ABBAS WAS ADVISED TO PERFORM AN EMERGENCY STOP IN THESE SITUATIONS TO REMOVE INSTRUMENTS FROM THE PATIENT SIDE WITHOUT A SYSTEM ERROR. SEVERAL FOLLOW UP ATTEMPTS WITH THE SITE HAVE BEEN MADE CONCERNING THE PATIENT'S STATUS, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION BECOMES AVAILABLE. AS OF (B)(4) 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS 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": "" } ] }