{ "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": "2955842-2021-10487", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210508", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210412", "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": "WANG", "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": "20210508", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200903", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "691559", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210508", "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": "T90200903 0177", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210511", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)220930(10)T90200903", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Device Fell", "Detachment of Device or Device Component", "Device Fell" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/12/2021;04/12/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20210508", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210412", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11795228", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210412", "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": "249727428", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN RMA HAS BEEN ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE SYNCHROSEAL INSTRUMENT RETURNED; HOWEVER, ISI HAS NOT RECEIVED THE RMA TO CONFIRM/IDENTIFY ANY REPORTABLE FAILURE MODE(S). A REVIEW OF SYSTEM LOGS WAS PERFORMED. PER THE REVIEW, THE DEVICE WAS NOT USED ON THE REPORTED EVENT DATE OF (B)(6) 2021. THE SYNCHROSEAL INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM ((B)(4)). THE SYNCHROSEAL INSTRUMENT HAS NO LIVES REMAINING AS IT IS A SINGLE-USE INSTRUMENT. A SITE COMPLAINT HISTORY REVIEW WAS PERFORMED AND NO ADDITIONAL COMPLAINTS FOR THIS PRODUCT WAS IDENTIFIED. SYNCHROSEAL IS A BIPOLAR ELECTROSURGICAL INSTRUMENT FOR USE WITH A COMPATIBLE DA VINCI SURGICAL SYSTEM AND A COMPATIBLE ELECTROSURGICAL GENERATOR. IT IS INTENDED FOR GRASPING, DISSECTION, SEALING AND TRANSECTION OF TISSUE. SYNCHROSEAL CAN BE USED TO SEAL VESSELS UP TO AND INCLUDING 5 MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: PER THE EVENT DESCRIPTION, THERE IS NO INDICATION THAT THE PRODUCT WAS NOT BEING USED AS INTENDED. IT WAS ALLEGED THAT A FRAGMENT FROM THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED; HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE FRAGMENT TO FALL INSIDE THE PATIENT. ALTHOUGH THERE WAS NO PATIENT INJURY THAT RESULTED FROM THE FRAGMENT FALLING INSIDE THE PATIENT, IF THIS EVEN WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "249727429", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, AFTER INSERTING THE SYNCHROSEAL INSTRUMENT INTO THE BODY CAVITY IMMEDIATELY AFTER THE START OF SURGERY, THE PART WHICH HOLDS THE JAW COVER FELL INTO THE BODY WHEN THE WRIST WAS MOVED. THE PART WAS REPORTEDLY IMMEDIATELY RETRIEVED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER ON 15-APRIL-2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION RELATED TO THE EVENT. THE FRAGMENT WAS RETRIEVED BY USING THE SYNCHROSEAL INSTRUMENT. NO POST-OPERATIVE TESTS WERE REQUIRED AS IT WAS VISUALLY CONFIRMED THAT NO OTHER FRAGMENTS REMAINED INSIDE THE PATIENT. IT WAS UNKNOWN WHETHER THE INSTRUMENT WAS INSPECTED PRIOR TO USE, BUT REPORTEDLY THE INSTRUMENT DID COLLIDE WITH OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE INSTRUMENT WAS NOT REMOVED INTRAOPERATIVELY. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED THERE WAS NO RESISTANCE FELT UPON REMOVAL THROUGH THE CANNULA, AND THERE WAS NO DAMAGE NOTED TO EITHER THE INSTRUMENT OR THE CANNULA. IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT INJURY THAT RESULTED FROM THE EVENT." }, { "mdr_text_key": "335847630", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED." }, { "mdr_text_key": "335847631", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "324685546", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D11 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) CONFIRMED THE REPORTED ISSUE AS THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED DISTAL WASHER. THE WASHER WAS RETURNED WITH THE INSTRUMENT AND THERE WAS NO DAMAGE TO THE DISTAL PIN OBSERVED. THE INSTRUMENT PASSED IN HOUSE TESTING AS IT MOVED IN ALL DIRECTIONS AND THE JAWS OPENED/CLOSED PROPERLY. THE INSTRUMENT PASSED JAW CERAMIC DOT VERIFICATION AND CERAMIC DOT SWIPE TESTS. THERE WERE NO FAILURES FOUND IN LOGS. ADVANCED FA (AFA) FURTHER ANALYZED THE INSTRUMENT AND THE FOLLOWING INFORMATION WAS OBSERVED: AFA CONFIRMED THE INITIAL FA INVESTIGATION. THE PIVOT PIN WASHER WAS DISLODGED FROM THE PIVOT PIN AND AFA FOUND IT TO BE ADEQUATELY SWAGED. THE PIVOT PIN WAS SECURE WITHIN THE INSTRUMENT JAW ASSEMBLY. THERE WAS NO DAMAGE TO THE JAW COVER OR PIVOT PIN AS THE PIVOT PIN WAS SECURE IN THE JAW OF THE INSTRUMENT AND COULD NOT BE REMOVED. THIS SUGGESTS THE DISLODGED PIN WAS ATTRIBUTED USER MISHANDLING SUCH AS COLLISIONS, IMPROPER REMOVAL OR CLEANING." } ], "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": "06/05/2021;05/24/2023" } ] }