{ "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": "", "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": "2955842-2009-00106", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20090313", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20090212", "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": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20090323", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20090313", "brand_name": "DA VINCI 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": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS1200 A4. 3P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Component(s), overheating of" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20090313", "sequence_number_treatment": [ "DA VINCI SURGICAL SYSTEM INSTRUMENTS", " ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20090212", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1345068", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20090212", "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": "1061524", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE ENDOSCOPE TIP BECAME VERY HOT AND BURNT THE PATIENT'S BOWEL. SURGICAL INTERVENTION WAS NOT REQUIRED, AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES." }, { "mdr_text_key": "8177597", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INVESTIGATION WAS CONDUCTED BY ISI FIELD SERVICE ENGINEERING, WHO PERFORMED EXTENDED TESTING ON THE SYSTEM ILLUMINATOR AND ILLUMINATOR LAMP MODULE. THE ILLUMINATOR AND LAMP MODULE (LOCATED WITHIN THE ILLUMINATOR) PROVIDES LIGHT, WHICH IS THEN DELIVERED TO THE ENDOSCOPE VIA A FIBER OPTIC LIGHT GUIDE CABLE AND PROJECTED ONTO THE SURGICAL SITE. AFTER APPROX 1 HOUR OF TESTING, NO CHANGE TO THE LUMENS OUTPUT WAS OBSERVED AND THE ENDOSCOPE TIP DID NOT BECOME ABNORMALLY HOT. THE ILLUMINATOR WAS REPLACED AS A PRECAUTION. FURTHER INVESTIGATION REVEALED THAT THE SITE RECENTLY CHANGED THEIR SINGLE LIGHT GUIDE TO A BIFURCATED LIGHT GUIDE, WHICH WAS USED DURING THE PROCEDURE. SINCE THE BIFURCATED LIGHT GUIDE EMITS A HIGHER LIGHT OUTPUT THAN THE SINGLE LIGHT GUIDE, ENGINEERING CONCLUDED THAT THE SITE'S UNFAMILIARITY WITH THE BIFURCATED LIGHT GUIDE MAY HAVE CONTRIBUTED TO THE HIGH HEAT EXPERIENCED AT THE ENDOSCOPE TIP AS THE PROPER WORKING DISTANCE AND SETTING ADJUSTMENTS MAY NOT HAVE BEEN MADE TO ACCOMMODATE FOR THE CHANGE. AS OF 2009, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE A 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": "" } ] }