{ "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": "2955842-2022-13942", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220911", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220809", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20220911", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220307", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1306872", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220911", "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": "L90220309 0344", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20220907", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)240331(10)L90220309", "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": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20220911", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220811", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15397832", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220811", "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": "299668654", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED COMPLAINT. THE INSTRUMENT PIVOT PIN WASHER WAS NO LONGER ATTACHED TO THE JAW COVER AT THE WRIST ASSEMBLY. THE PIVOT PIN WASHER, APPROXIMATELY 0.11\" X 0.11\" IN SIZE, WAS RETURNED BY THE CUSTOMER. NO MATERIAL APPEARED TO BE MISSING. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A DISLODGED WASHER TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. ROOT CAUSE IS ATTRIBUTED TO MISHANDLING OR MISUSE. A REVIEW OF THE DEVICE LOGS FOR THE SYNCHROSEAL INSTRUMENT (PART# 480440-05/ LOT/SERIAL# (B)(4) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. THE SYNCHROSEAL INSTRUMENT WAS LAST USED ON (B)(6) 2022 ON SYSTEM SERIAL# (B)(4). THIS COMPLAINT IS CONSIDERED 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," }, { "mdr_text_key": "299668655", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A CUSTOMER REPORTED THAT SYNCHROSEAL INSTRUMENT WAS BROKEN. A FRAGMENT FELL INTO THE PATIENT¿S ANATOMY AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS REMOVED WITH A FORCEPS INSTRUMENT. IT WAS CONFIRMED VIA ENDOSCOPE THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED. AN X-RAY WAS PERFORMED AFTER THE PROCEDURE AS USUAL. THE SURGEON BELIEVED THAT THE SYNCHROSEAL INSTRUMENT COLLIDING WITH ANOTHER INSTRUMENT WAS THE CAUSE OF THE FRAGMENT FALLING INTO PATIENT. THE SYNCHROSEAL WAS INSPECTED PRIOR TO USE WITH NO ISSUE. A VESSEL SEALING TASK WAS BEING PERFORMED WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT REMOVE THE INSTRUMENT PRIOR TO THE INSTRUMENT BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE TO THE CANNULA AND NO OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THERE WAS NO PATIENT INJURY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO COMPLICATIONS FROM RETAINING A FOREIGN OBJECT." } ], "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": "" } ] }