{ "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": "2955842-2016-00247", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160415", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20160316", "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": "", "manufacturer_contact_area_code": "", "date_added": "20160415", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "236010", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160415", "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 A60P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "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": [ "Component Falling" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20160415", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20160316", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5581057", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160316", "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": "42792888", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE FSE EVALUATED THE DA VINCI SURGICAL SYSTEM INVOLVED WITH THIS COMPLAINT AND WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE. NO TROUBLE WAS FOUND. IT IS UNCLEAR IF THE SURGEON'S HEAD WAS STILL IN THE HRSV WHEN THE REPORTED EVENT OCCURRED. PER THE DA VINCI SI SURGICAL SYSTEM USER MANUAL, THE FOLLOWING IS NOTED: CAUTION: THE INFRARED HEAD SENSORS PERFORMS A SAFETY FUNCTION BY PREVENTING MOVEMENT OF THE PATIENT CART ARMS WHEN THE SURGEON'S HEAD IS NOT IN THE VIEWER. DO NOT DEFEAT THIS SAFETY FEATURE BY INTENTIONALLY BLOCKING THE SENSORS. ALSO, THE USER MANUAL 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 FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS AND VERIFIED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THE SITE HAS PERFORMED MULTIPLE SUBSEQUENT SURGICAL PROCEDURES WITH THE DA VINCI SURGICAL SYSTEM INVOLVED WITH THIS COMPLAINT WITH NO REPORTED RECURRENCES OF THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED A LACERATION OF THE TONGUE THAT WAS REPAIRED WITH HAND-SEWN SUTURES. HOWEVER, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "42792889", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT TOWARDS THE END OF A DA VINCI-ASSISTED TRANSORAL ROBOTIC (TORS) PROCEDURE, THE ARMS OF THE PATIENT SIDE CART (PSC) ALLEGEDLY MOVED ON THEIR OWN AS THE SURGEON GOT UP FROM THE SURGEON SIDE CONSOLE (SSC). ACCORDING TO THE INITIAL REPORTER, AS THE SURGEON REMOVED HIS HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV), ARM 1 AND ARM 2 MOVED FROM A VERTICAL TO HORIZONTAL POSITION WITH INSTRUMENTS STILL INSTALLED ON BOTH ARMS. AS A RESULT, ONE OF THE INSTRUMENTS ALLEGEDLY INJURED THE PATIENT'S TONGUE. THERE WERE NO REPORTS OF ANY SYSTEM ERROR MESSAGES. AFTER THE EVENT OCCURRED, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR ASSISTANCE. THE TSE REVIEWED THE SITE'S SYSTEM LOGS AND VERIFIED THAT THERE WERE NO RELATED SYSTEM ERROR MESSAGES. THE TSE HAD THE INITIAL REPORTER MOVE THE ARMS WITHOUT PRESSING ANY OF THE CLUTCH BUTTONS. THE INITIAL REPORTER WAS ABLE TO MOVE THE ARMS WHICH RETURNED TO THE SOFT-LOCK POSITION AS EXPECTED. ON (B)(6) 2016, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUES WITH THE ARMS OF THE PSC. THE FSE TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ON (B)(6) 2016, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: AT THE END OF THE SURGICAL PROCEDURE, THE SURGEON WAS IN THE PROCESS OF ATTEMPTING TO BACK UP THE ENDOSCOPE. THE ROBOTICS COORDINATOR STATED THAT SHE WAS NOT LOOKING AT THE SURGEON DIRECTLY WHEN THE EVENT OCCURRED. HOWEVER, SHE EXPLAINED THAT SHE HEARD THE WHEELS OF THE SURGEON'S CHAIR MOVING AND CONCLUDED THAT THE SURGEON WAS LIKELY GETTING UP FROM THE CHAIR. SHE DID NOT KNOW IF THE SURGEON'S HEAD WAS STILL IN THE HRSV WHEN SHE CLAIMED THAT BOTH ARMS FELL. THE ROBOTICS COORDINATOR CONFIRMED THAT THEY DID NOT GET ANY SYSTEM ERROR MESSAGES WHEN THE EVENT OCCURRED. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT SUSTAINED A LACERATION TO THE TONGUE AS A RESULT OF THE ARMS DROPPING. THE TONGUE INJURY WAS REPAIRED BY THE SURGEON WITH HAND-SEWN SUTURES. TO HER KNOWLEDGE, THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE ROBOTICS COORDINATOR STATED THAT THE SURGEON PERFORMED ANOTHER DA VINCI-ASSISTED TORS PROCEDURE A WEEK LATER AND DID NOT HAVE ANY ISSUES." } ], "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": "" } ] }