{ "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": "2955842-2023-13163", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230513", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20200804", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230513", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20191014", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1043929", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230513", "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": "T91191014 0046", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200812", "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)211031(10)T91191014", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break", "Break" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20230513", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "45 YR", "patient_sex": "Female", "patient_weight": "59 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20200805", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16925241", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200805", "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": "315170753", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED/REPLICATED THE REPORTED COMPLAINT. THE INSTRUMENT WAS NOTED TO HAVE A MISSING JAW COVER. NO CERAMIC DOTS WERE MISSING INSIDE THE JAW. THE MISSING JAW COVER WAS NOT RETURNED WITH THE INSTRUMENT. THE WRIST PIN AND WASHERS WERE SWAGED BUT THEY ARE STILL INTACT. NO DAMAGES WERE FOUND ON THE WRIST DISCS OR THE WRIST DISC WELDS. THE INSTRUMENT WAS BROKEN FURTHER AND REVEALED THE JAW COVER INSERTS WERE STILL PRESENT UNDERNEATH THE WRIST DISCS AND INTACT. THE INSTRUMENT WAS ASSEMBLED PROPERLY. THE EDGES OF THE REMAINING JAW COVER MATERIAL ON THE INSERTS WERE TORN. A SAMPLE JAW COVER WAS RIPPED OFF FROM A SCRAPPED SYNCHROSEAL INSTRUMENT. THE EDGES OF THE REMAINING MATERIAL ON A SCRAPPED SYNCHROSEAL INSTRUMENT WERE THE SAME AS THE EDGES ON THE RETURNED SYNCHROSEAL INSTRUMENT. THIS FAILURE IS TYPICALLY ASSOCIATED WITH MISHANDLING/MISUSE." }, { "mdr_text_key": "315170754", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A SMALL GRAY COVER ON THE END OF THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED DURING THE SAME PROCEDURE. THE SURGEON USED A VESSEL SEALER INSTRUMENT TO CONTINUE AND THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, INJURY OR ADVERSE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE INSTRUMENT WAS IN USE FOR 15 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. PRIOR TO INSTRUMENT USAGE, THE SCRUB TECH WAS ATTEMPTING TO PEEL OFF THE YELLOW PROTECTIVE COVER ON TOP OF THE JAW COVER AND MIGHT HAVE LOOSE THE JAW COVER DURING THE PROCESS. THE SURGEON WAS DISSECTING A TISSUE WHEN A FRAGMENT FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH A GRASPER INSTRUMENT. THERE WAS NO INSTRUMENT COLLISION DURING THE PROCEDURE." } ], "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": "" } ] }