{ "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": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2021-11636", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20211201", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20211007", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20211201", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210614", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1808932", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211201", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "480440-05", "catalog_number": "480440", "lot_number": "L90210615 0129", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)230630(10)L90210615", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250728", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20211201", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Obstruction/Occlusion", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20211105", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12911986", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211105", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "285071642", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE ALLEGED OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE SYNCHROSEAL INSTRUMENT WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE VIDEO SENT BY THE CUSTOMER WAS PERFORMED BY THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL DEVELOPMENT ENGINEERING (CDE) TEAM AND THE FOLLOWING FINDINGS WERE OBTAINED: MANY PHYSICAL INTERACTIONS OF INSTRUMENTS WITH URETER WERE OBSERVED THROUGHOUT VIDEOS, BUT NONE SEEMED TO CAUSE TISSUE DAMAGE. THERE WAS NO THERMAL EFFECT BEING GENERATED FROM THE WRIST OF THE SYNCHROSEAL OBSERVED AT ANY POINT. THERE WERE ALSO MANY INSTANCES OF SYNCHROSEAL ACTIVATION WHILE THE WRIST OF THE INSTRUMENT WAS IN CONTACT WITH ILIAC VESSELS, BUT NO INJURY OR THERMAL EFFECT WAS SEEN TO VESSELS. THE CDE TEAM REVIEWED THE EVENT INFORMATION AND NOTED THE FOLLOWING: IF THERE ARE NO COMPONENT FAILURES, THE INSTRUMENT SHOULD ONLY DELIVER ENERGY THROUGH THE JAWS. THERMAL SPREAD AND ENERGY TRANSFER THROUGH FLUID ARE BOTH POSSIBLE AND THUS, THE LOWEST POSSIBLE ENERGY SETTINGS IS RECOMMENDED TO ACHIEVE THE DESIRED EFFECT. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ADDITIONALLY, ALL REUSABLE INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES WITH THE EXCEPTION OF THE MONOPOLAR CURVED SCISSOR (MCS) AND A SITE REVIEW SHOWS NO COMPLAINT FILED AGAINST THE INSTRUMENTS. THE SYNCHROSEAL LOG WAS REVIEWED BY AN ISI ADVANCED FAILURE ANALYSIS ENGINEER (FAE) AND THE FOLLOWING FINDINGS WERE OBTAINED: THE SYNCHROSEAL INSTRUMENT WAS INSTALLED FOR 5 HOURS AND 40 MINUTES. IN THE E-100 LOGS, THERE IS ONE HIGH INITIAL STARTING IMPEDANCE MESSAGE, AND ONE CUT ELECTRODE SHORTED MESSAGE. THE CUT ELECTRODE SHORT IS LIKELY DUE TO AN ARCING EVENT- HOWEVER, ARCING EVENTS THAT REMAIN BETWEEN THE JAWS OF THE INSTRUMENT ARE AN EXPECTED CONDITION OF THE BIPOLAR CUT FUNCTION AND DOES NOT INDICATE AN INSTRUMENT FAILURE. HIGH INITIAL STARTING IMPEDANCE IS LIKELY DUE TO TISSUE TYPE, DRYNESS, OR THICKNESS AND DOES NOT INDICATE AN INSTRUMENT FAILURE. THE SNAKE WRIST OF THE SYNCHROSEAL INSTRUMENT IS NOT ENERGIZED, SO IT WOULD NOT GENERATE ANY HEAT ITSELF. HOWEVER, THE IFU DO CAUTIONS AGAINST POTENTIAL THERMAL SPREAD TO ADJACENT TARGET TISSUE. ADDITIONALLY, IF THE INSTRUMENT IS IMMERSED IN A CONDUCTIVE FLUID, HEAT ENERGY MAY CARRY HEAT AWAY FROM THE TARGET TISSUES. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: AFTER COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY-MALIGNANT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A URETERAL OBSTRUCTION AND RE-HOSPITALIZED. THE CAUSE OF THE ALLEGED OPERATIVE COMPLICATION IS UNKNOWN. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IS NOT AVAILABLE. ARE NOT APPLICABLE." }, { "mdr_text_key": "285071643", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS INITIALLY REPORTED BY A DOCTOR THAT AFTER A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A URETERAL STRICTURE OCCURRED AND WAS PROBABLY DUE TO HEAT DAMAGE. THE DOCTOR SPECULATES THAT HEAT WAS TRANSFERRED FROM THE WRIST OF THE SYNCHROSEAL INSTRUMENT TO THE URETER AND THAT THERMAL DAMAGE TO THE URETER CAUSED A STRICTURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON FROM THE SITE AND OBTAINED THE FOLLOWING INFORMATION ON (B)(6) 2021. THE SYNCHROSEAL INSTRUMENT WAS EXAMINED BEFORE USE AND THERE WERE NO ABNORMALITIES SEEN. THE SURGEON DID NOT HAVE ANY ISSUES USING THE SYNCHROSEAL INSTRUMENT AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DETECTED DURING THE PROCEDURE. THE JAWS OF THE SYNCHROSEAL INSTRUMENT WERE NOT IMMERSED IN CONDUCTIVE FLUIDS AND DID NOT COME INTO CONTACT WITH ANY NON-TARGET TISSUE OR METALLIC OBJECTS WHILE ENERGIZED. ADDITIONALLY, THE SYNCHROSEAL INSTRUMENT WAS NOT USED TO ENERGIZE THE TIPS OF OTHER INSTRUMENTS AND THE SURGEON HAD GOOD VISIBILITY OF THE JAWS AS WELL AS THE ANATOMY SURROUNDING THE INSTRUMENT DURING SYNCHROSEAL ACTIVATIONS. THERE WAS NO ARCING/BURNING SEEN. THE SURGEON CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT WAS NOT OPERATING CLOSE TO THE MONOPOLAR CURVED SCISSORS DURING THE PROCEDURE. THE SURGEON CONFIRMED THAT THE WRIST OF THE SYNCHROSEAL INSTRUMENT WAS IN CONTACT WITH THE PATIENT'S URETER FROM VIEWING A VIDEO RECORDING OF THE PROCEDURE. THE SURGEON MENTIONED THAT THERE IS A POSSIBILITY THAT THE URETER WAS CUT DURING TISSUE DISSECTION. THE PATIENT WAS RE-HOSPITALIZED AND DIAGNOSED WITH A URETERAL OBSTRUCTION WHICH WILL POSSIBLY REQUIRE RECONSTRUCTION OF THE URETER 3 MONTHS LATER. THE SURGEON FURTHER MENTIONED THAT HE BELIEVES THAT HE MAY HAVE MISTAKENLY SEALED THE URETER WITH THE SYNCHROSEAL INSTRUMENT. ANOTHER POSSIBLE CAUSE ACCORDING TO THE SURGEON WAS CONTACT TO THE URETER IN RELATION TO \"COMPRESSION OF TISSUE AFTER SEALING.\" THE SYNCHROSEAL INSTRUMENT WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR EVALUATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }