{ "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": "2955842-2023-16518", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20230622", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20230525", "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", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20230622", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230105", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "133321", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230622", "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": "L11230108 0312", "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)250131(10)L11230108", "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": "07/11/2023;08/09/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20230622", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230525", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17183489", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230525", "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": "317722533", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DEVICE FOR FAILURE ANALYSIS EVALUATION. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE." }, { "mdr_text_key": "317722534", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT HAD BOTH \"RINGS\" FALL OFF. ONE RING WAS RECOVERED, THE SECOND ONE WAS LOST IN SITU. WHEN PULLING OUT THE INSTRUMENT, THE METAL CABLE WAS OBSERVED AT THE DISTAL END OF THE SHAFT. IT WAS REPORTED THAT A FRAGMENT FELL INTO THE PATIENT AND WAS UNKNOWN IF RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY AND LESS THAN A 15-MINUTE DISPLAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED ADDITIONAL INFORMATION: THE \"RING\" WAS DESCRIBED AS THE \"PROTECTIVE SCREW\" AT THE DISTAL END. ADDITIONALLY, AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS RESECTING A LARGE-VOLUME MALIGNANT TUMOR IN THE AREA OF THE MIDDLE PART OF THE MESO ROOT. THE SYNCHROSEAL INSTRUMENT WAS USED FOR DISSECTION AND TO CUT/SEAL SMALLER BLOOD VESSELS. THE FRAGMENT/PART WAS DESCRIBED AS BEING SIMILAR TO A WASHER AND WAS DISCOVERED LYING RETROPERITONEALLY. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WERE NO KNOWN COLLISIONS DURING THE PROCEDURE. THE CUSTOMER FELT RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA AND CANNULA DAMAGE WAS OBSERVED. A POST-OPERATIVE X-RAY WAS PERFORMED IN THE OR; HOWEVER, THE RESULTS WERE NOT PROVIDED. IT IS UNKNOWN IF ALL FRAGMENTS WERE RETRIEVED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A MISSING FRAGMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO FURTHER REPORTED INJURY." }, { "mdr_text_key": "336894621", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336894622", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT WAS EVALUATED BY THE FAILURE ANALYSIS (FA) ADVANCED ENGINEERING TEAM. THE INITIAL FAILURE ANALYSIS WAS CONFIRMED. THE PIVOT PIN WAS REMOVED FROM THE INSTRUMENT AND THE TWO ENDS WERE INSPECTED. IT WAS NOTICED THAT ONE OF THE ENDS OF THE PIVOT PIN WAS IMPROPERLY SWAGED, DUE TO WHICH THE WASHER ON THAT SIDE POPPED OFF. THE PIVOT PIN WAS OBSERVED TO BE BENT, WHICH IS LIKELY DUE TO MISHANDLING THE INSTRUMENT AFTER THE WASHERS FELL OFF." }, { "mdr_text_key": "335425250", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335425251", "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 INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION WAS PERFORMED, AND THE INSTRUMENT WAS FOUND TO HAVE BOTH OF THE DISTAL WASHERS DISLODGED FROM THE DISTAL END. ONE OF THE DISTAL WASHERS WAS RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAWS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED JAW CERAMIC DOT VERIFICATION AND CERAMIC DOT SWIPE TESTS. NO FAILURES WERE FOUND DURING REVIEW OF THE SYSTEM LOGS. ADDITIONAL OBSERVATIONS: THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED PIVOT PIN AT THE DISTAL END. THE DISLODGED PIN WAS OBSERVED TO BE STILL ATTACHED TO THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE A TORN JAW COVER. THE TEAR MEASURED APPROXIMATELY 0.030\" - 0.046\" IN LENGTH. NO MATERIAL APPEARS TO BE MISSING. THE INSTRUMENT WAS FOUND TO HAVE A DAMAGED CUT ELECTRODE. THE SILICONE OVERMOLDING WAS FOUND TO EXHIBIT TEARS. NO MATERIAL APPEARS TO BE MISSING." } ], "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": "08/04/2023;09/06/2023" } ] }