{ "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": "2955842-2022-13823", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220902", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220804", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20220902", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211021", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2446922", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220902", "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": "480440-06", "catalog_number": "480440", "lot_number": "L91211026 0017", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "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)231031(10)L91211026", "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", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/07/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "health_professional": "Y", "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": "20220902", "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": "20220804", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15352761", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220804", "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": "299267232", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE SYNCHROSEAL INSTRUMENT BE RETURNED FOR EVALUATION, HOWEVER IT HAS NOT YET BEEN RECEIVED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE EVENT LOG SHOWS THAT ON (B)(6) 2022, DURING A SIGMOID COLECTOMY SURGICAL PROCEDURE THAT WAS PERFORMED ON SYSTEM SL0516, THERE WERE TWO SYNCHROSEAL INSTRUMENTS WERE USED (LOT# L91211026-0017 AND LOT# L91211026-0022). HOWEVER, THE CUSTOMER DID NOT SPECIFY WHICH OF THE TWO INSTRUMENTS WAS THE REPORTED FAULTY DEVICE. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY. AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION." }, { "mdr_text_key": "299267233", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, A SMALL METAL RING FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENT WAS REPORTEDLY RETRIEVED DURING A DIFFERENT PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "332900358", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "332900359", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WASHER WAS RETRIEVED WITH A LAPAROSCOPIC GRASPING FORCEPS DURING THE SAME PROCEDURE. ISI HAS RECEIVED THE SYNCHROSEAL INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FA FOUND THE PRIMARY FAILURE OF DISLODGED PIVOT PIN WASH TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE SYNCHROSEAL INSTRUMENT WAS FOUND WITH A PIVOT PIN WASHER DISLODGED FROM THE JAW COVER. THE SYNCHROSEAL INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE SYNCHROSEAL INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS, MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIPS OPENED AND CLOSED PROPERLY. UPON VISUAL INSPECTION, THE JAW CERAMIC DOTS WERE PRESENT. THE ENERGY WAS DELIVERED WITHOUT ANY ISSUES JAW GAP VERIFICATION PASSED AT 0.003¿. THE WASHER WAS RETURNED WITH THE INSTRUMENT. NO ERRORS OCCURRED DURING IN-HOUSE TESTING. A REVIEW OF LOGS SHOWED NO FAILURES. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED MISHANDLING/MISUSE. ADDITIONAL EVALUATION WAS PERFORMED BY AN ADVANCED FAILURE ANALYSIS ENGINEER. THE INITIAL FAILURE ANALYSIS WAS CONFIRMED. THE INSTRUMENT WAS OBSERVED TO HAVE THE PIVOT PIN WASHER DISLODGED. AFTER MICROSCOPIC INSPECTION IT WAS DETERMINED THAT THE PIVOT PIN WAS DEFORMED. AFTER FURTHER EXAMINATION IT WAS CONCLUDED THAT THE PIVOT PIN WAS IMPROPERLY SWAGED AT MANUFACTURING. THIS IS A MANUFACTURING-RELATED FAILURE." } ], "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": "12/05/2022" } ] }