{ "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": "2955842-2022-10847", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220401", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220221", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220401", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210902", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1013393", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220401", "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": "L90210905 0289", "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)230930(10)L90210905", "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": "NV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/06/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20220401", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "37 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220302", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13980883", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220302", "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": "293696177", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY THE CUSTOMER HAD ISSUES WITH THE FRAGMENT COMING OFF THE SYNCHROSEAL INSTRUMENT. CUSTOMER RETRIEVED FRAGMENT. INTUITIVE SURGICAL INC. (ISI) CONFIRMED THAT THE FRAGMENT CAME OFF THE DEVICE INTO THE PATIENT DURING PROCEDURE. THERE WERE NO POST-OPERATIVE COMPLICATIONS. THE SURGEON USED ANOTHER INSTRUMENT TO MANUALLY RETRIEVE THE FRAGMENT AND INSPECTED VISUALLY TO ENSURE FOREIGN MATERIAL WAS REMOVED. NO PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION OF AN ENERGY ISSUE." }, { "mdr_text_key": "293696178", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT REPORTED TO BE INVOLVED IN THIS INCIDENT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. SYSTEM LOG REVIEW CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT WAS LAST USED ON (B)(6) 2022 WITH 0 USES REMAINING ON SYSTEM (B)(4). NO OTHER COMPLAINTS RELATED TO THIS PRODUCT WERE IDENTIFIED. NO IMAGE OR PROCEDURE VIDEO WERE PROVIDED. 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 WITH NO PATIENT INJURY. DEVICE EXPIRATION DATE WAS LEFT BLANK. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA." }, { "mdr_text_key": "329460259", "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 FOUND THE PRIMARY FAILURE OF DISLODGED WASHER TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE SYNCHROSEAL INSTRUMENT WAS FOUND TO HAVE A DISLODGED PIVOT PIN WASHER. THE WASHER WAS RETURNED, MEASURING APPROXIMATELY 0.110\" IN DIAMETER WAS RETURNED. UPON INSPECTION, THE WASHER EXHIBITED PHYSICAL DAMAGE ON BOTH SIDES. THE PIVOT PIN DID NOT EXHIBIT ANY MECHANICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION, ENGAGEMENT, AND SELF-CHECK TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. UPON VISUAL INSPECTION, ALL 9 JAW CERAMIC DOTS WERE PRESENT AT THE TIPS. THE INSTRUMENT ARRIVED WITH THE ENERGY CABLE CUT AND COULD NOT BE TESTED FOR ENERGY DELIVERY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. MSC LOGS SHOWED NO FAILURES. AFTER FURTHER MICROSCOPIC EXAMINATION IT WAS DETERMINED THAT THE PIVOT PIN WAS IMPROPERLY SWAGED, THUS CAUSING THE WASHER TO BECOME DISLODGED. THIS IS ATTRIBUTED TO A MANUFACTURING RELATED ISSUE." }, { "mdr_text_key": "329460260", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "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": "06/03/2022" } ] }