{ "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": "2955842-2023-17630", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230810", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20230718", "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", "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": "20230810", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230126", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "797587", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230810", "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": "L11230126 0195", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230721", "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)L11230126", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Unintended System Motion", "Detachment of Device or Device Component", "Unintended System Motion", "Detachment of Device or Device Component" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/14/2023", "mfr_report_type": "Follow-Up", "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": "20230810", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "49 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230718", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17497680", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230718", "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": "336088659", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT WAS TRANSFERRED TO ENGINEERING AND EVALUATED BY THE FAILURE ANALYSIS ENGINEERING (FAE) TEAM. THE INITIAL FAILURE ANALYSIS (FA) EVALUATION WAS CONFIRMED. MICROSCOPIC INVESTIGATION OF THE PIVOT PIN REVEALED AN IMPROPERLY SWAGED END, WHICH IS KNOWN TO BE RESPONSIBLE FOR THE WASHER GETTING DISLODGED. THE ROOT CAUSE OF THIS IS TYPICALLY ATTRIBUTED TO MANUFACTURING. THE GRIP DAMAGE IS NOT RELATED TO THE WASHER GETTING DISLODGED, AS THE FORMER IS ATTRIBUTED TO MISHANDLING/MISUSE AND THE LATTER TO MANUFACTURING." }, { "mdr_text_key": "320876834", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT NOTING THAT WHEN THE SYNCHROSEAL INSTRUMENT WAS BEING REMOVED, IT MADE SOME ABNORMAL MOVEMENTS AND A SMALL PIECE OF IT FELL INTO THE PATIENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI SYNCHROSEAL INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A DISLODGED DISTAL WASHER. THE DISTAL WASHER WAS NOT RETURNED WITH THE INSTRUMENT. ADDITIONAL OBSERVATION NOT REPORTED BY SITE THAT IS RELATED TO THE PRIMARY FAILURE: THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP TIPS ASSEMBLY. THE LOCATION OF THE DAMAGE WAS AROUND THE DISLODGED DISTAL WASHER. A BROKEN PIECE APPROXIMATELY 0.06\" X 0.058\" IN SIZE 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 WAS REMOVED, AND NO ABNORMAL MOVEMENTS OBSERVED. THE COMPLAINT REGARDING A SMALL PIECE OF THE SYNCHROSEAL INSTRUMENT THAT FELL INTO THE PATIENT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN ISI REGULATORY POST-MARKET SURVEILLANCE ANALYST. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THE PIVOT PIN OF THE SYNCHROSEAL INSTRUMENT HAS A MACHINED END AND A SWAGED END WITH WASHERS AFFIXED ON BOTH SIDES. IF THE SWAGED END OF THE PIN IS INCOMPLETE, THE WASHER MAY BECOME SEPARATED, AND THE PIN CAN BECOME DISPLACED. IF THE SWAGED END OF THE PIN IS INCOMPLETE, THE WASHER MAY BECOME SEPARATED, AND THE PIN CAN BECOME DISPLACED. THE PROBABLE ROOT CAUSE MAY BE ATTRIBUTED TO EITHER DAMAGE DURING USE OR THE MANUFACTURING PROCESS. DAMAGE DURING USE CAN RESULT FROM INSTRUMENT COLLISIONS OR IMPROPER INTRAOPERATIVE CLEANING WITH ANOTHER INSTRUMENT. MANUFACTURING-RELATED FAILURES MAY BE CAUSED BY ISSUES OR VARIABILITY DURING THE SWAGING PROCESS." }, { "mdr_text_key": "320876835", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ADRENALECTOMY SURGICAL PROCEDURE, WHEN THE SYNCHROSEAL INSTRUMENT WAS BEING REMOVED, IT MADE SOME ABNORMAL MOVEMENTS AND A SMALL PIECE OF IT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON DOES NOT KNOW WHAT CAUSED THE FRAGMENT FAILING ISSUE. THE EXACT TIME OF HOW LONG THE INSTRUMENT WAS IN USE PRIOR TO THE ISSUE OCCURRING WAS UNKNOWN, BUT IT WAS DURING THE INITIAL WORK. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGEON SAW THE FRAGMENT FALL AS THE INSTRUMENT WAS BEING REMOVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO PATIENT INJURY. THE PATIENT HAD NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. THE FAILURE WAS NOT RELATED TO AN INABILITY TO MOVE THE INSTRUMENT AT ALL. THE ISSUE HAPPENED DURING AN INSTRUMENT CHANGE, NOT WHILE IN USE. THE INSTRUMENT WAS REMOVED FROM THE FIELD TO RESOLVE THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE." } ], "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": "09/01/2023" } ] }