{ "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": "2955842-2012-01440", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20121227", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121126", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN ASSISTANT", "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": "20121228", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121227", "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 A60P7", "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": [ "Positioning Problem" ], "reporter_state_code": "MO", "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": "20121227", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "93", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)" ] } ], "distributor_city": "", "date_report": "20121127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2888137", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121127", "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": "18278971", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI TRANSORAL ROBOTIC SURGERY (TORS), THE PATIENT SUFFERED A LIP BURN AFTER THE CANNULA CAME INTO CONTACT WITH THE PATIENT'S LIP AT THE BEGINNING OF THE TONGUE BASE RESECTION PROCEDURE. AT THE TIME OF THIS INCIDENT, THE SURGEON REPORTEDLY UTILIZED THE 5 MM MARYLAND DISSECTOR AND 5 MM MONOPOLAR CAUTERY INSTRUMENTS CONNECTED TO THE SECONDARY GROUNDING PAD, IN CONJUNCTION WITH THE RECOMMENDED FLARED CANNULA. TO PREVENT FURTHER HARM TO THE PATIENT, INTRAOPERATIVE REPOSITIONING OF THE DA VINCI SYSTEM WAS CONDUCTED, SUCH THAT THE CANNULA WAS PULLED WELL ABOVE THE LEVEL OF THE PATIENT'S LIP. THE INTENDED ROBOTIC PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CONVERSION." }, { "mdr_text_key": "18321624", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN ASSISTANT (PA) ON (B)(6) 2012, THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO THIS EVENT. THE SURGERY WAS STAGED BY PERFORMING THE TRANSORAL ROBOTIC SURGERY (TORS) FOR TONSIL CANCER FIRST, THEN UNDERGOING A SEPARATE (NON-ROBOTIC) NECK DISSECTION A FEW WEEKS THEREAFTER. IT IS HER PROFESSIONAL BELIEF THAT THE LIP BURN WAS CAUSED DUE TO THE PATIENT'S JAW BEING TOO NARROW. PER THE PA, AS SOON AS THE LIP BURN WAS NOTICED, A RETRACTOR TOOL WAS USED TO WIDEN THE JAW AREA TO PROPERLY POSITION THE INSTRUMENTS WITHOUT ANY FURTHER HARM TO THE PATIENT. THE PA WAS UNSURE WHETHER THE ENERGY FROM THE INSTRUMENT CAUSED THE LIP BURN OR WHETHER IT WAS CAUSED BY CONTACT WITH THE CANNULA. HOWEVER, NO ARCING FROM ANY INSTRUMENT WAS OBSERVED DURING THE PROCEDURE. AN ATTEMPT WAS MADE TO RETRIEVE THE INSTRUMENTS BACK FOR ANALYSIS, HOWEVER, IT WAS STATED THAT THEY HAVE SINCE BEEN USED IN OTHER CASES AND NO MALFUNCTIONS WERE OBSERVED. THE ELECTROSURGICAL UNIT (ESU) MODE AND SETTING (COAGULATION/CUT LEVELS) WERE UNKNOWN. REPORTEDLY, THE PATIENT IS DOING VERY WELL AT THIS TIME. NO FURTHER INFORMATION WAS AVAILABLE. THE TORS PROCEDURE REFERENCE GUIDE RECOMMENDS THAT THE 5MM FLARED CANNULA BE USED IN CONJUNCTION WITH THE ENDOWRIST 5MM CAUTERY INSTRUMENTS DURING DA VINCI SI SURGICAL PROCEDURES. INVESTIGATION HAS SHOWN THAT IT IS POSSIBLE FOR THE ESU CURRENT TO PASS THROUGH THE PATIENT SIDE MANIPULATOR (PSM) ARMS TO GROUND, AND THROUGH THE CANNULA ACCESSORY TO THE PATIENT, IF THE PATIENT IS NOT PROPERLY GROUNDED. HOWEVER, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DEFINITIVELY DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. 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": "" } ] }