{ "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": "2955842-2023-11986", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20230415", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20230320", "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", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20230415", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220922", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1740332", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230415", "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": "L10220926 0200", "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)240930(10)L10220926", "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": "05/13/2023;08/01/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20230415", "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", "No Clinical Signs, Symptoms or Conditions", "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230320", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16748314", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230320", "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": "336654107", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS (FA) CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. FA FOUND THAT THE PRIMARY FAILURE OF THE DISLODGED SPRING PAD WAS RELATED TO THE CUSTOMER REPORTED COMPLAINT. FA PERFORMED A VISUAL INSPECTION THAT REVEALED THAT THE SPRING PAD APPEARED TO BE DISLODGED. THE SPRING PAD WAS ATTACHED TO THE CUT ELECTRODE, AND THE HEAT STAKE UNDER THE CUT ELECTRODE APPEARED TO BE DEFORMED. ADDITIONAL OBSERVATIONS FOUND BY FA AND NOT REPORTED BY THE SITE: THE SYNCHROSEAL INSTRUMENT WAS FOUND THAT THE JAW WRIST COVER WAS TORN. THE TEARS FOUND MEASURED ROUGHLY 0.066\" AND 0.023\". VISUAL INSPECTION PERFORMED BY FA DISPLAYED NO SIGNS OF MISSING FRAGMENTS." }, { "mdr_text_key": "336654108", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336746130", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT HAS BEEN RETURNED AND EVALUATED BY THE ENGINEERING TEAM. FAILURE ANALYSIS (FA) CONFIRMED THEIR INITIAL FINDINGS. THE SYNCHROSEAL INSTRUMENT'S CUT ELECTRODE WAS FOUND TO BE DISLODGED. THE LOGS WERE REVIEWED, AND IT SHOWED THAT THE SYNCHROSEAL INSTRUMENT WAS USED FOR ABOUT TWO HOURS AND 50 MINUTES. THERE WERE NO ELECTRODES SHORTED ERRORS THAT WERE SEEN IN THE E-100 GENERATOR LOGS THAT WOULD HAVE CAUSED THERMAL DAMAGE AND SUBSEQUENT MELTING AND DEFORMATION OF THE HEAT STAKE." }, { "mdr_text_key": "336746131", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "313389317", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE ON THE SYNCHROSEAL INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ALTHOUGH THE COMPLAINT REGARDING REPORTED FAILURE WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED. ONE OF THE IMAGES IS CONSISTENT WITH A SYNCHROSEAL INSTRUMENT WITH MISSING MATERIAL (SPRING PAD) ON THE JAWS. THIS COMPLAINT IS CONSIDERED A REPORTABLE ADVERSE EVENT AND MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: THE COMPLAINT INDICATES THAT IT IS UNKNOWN IF A FRAGMENT FELL INSIDE THE PATIENT, AND TESTS WERE PERFORMED TO ATTEMPT TO LOCATE THE FRAGMENT. AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR AND WHERE THE BROKEN PIECES ARE." }, { "mdr_text_key": "313389318", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SPRING PAD FOR THE SYNCHROSEAL INSTRUMENT HAD BECOME DETACHED AND THERE WAS BREAKAGE ON THE ELECTRODE SURFACE FOR CUTTING. THE SURGEON STATED THAT THEY VERIFIED NO FALLEN FRAGMENT BY INSPECTING THE PATIENT AND PERFORMING AN X-RAY. THE SURGEON WAS UNABLE TO FULLY CONFIRM NO FALLEN FRAGMENT AND BELIEVED THAT THE SPRING PAD COULD HAVE BEEN \"SUCKED IN.\" THE CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT WHEN THE MECHANICAL NURSE OPENED THE JAWS OF THE SYNCHROSEAL INSTRUMENT FOR CLEANING, THEY NOTICED THAT THE SPRING PAD AND THE ELECTRODE SURFACE FOR CUTTING WERE MISSING. THE MECHANICAL NURSE REPORTED THEIR FINDINGS TO THE SURGEON. THE PROCEDURE WAS IN THE FINAL STATE OF THE OPERATION, AND IT WAS CONFIRMED THAT THERE WERE NO REMNANTS OF THE FRAGMENTS DURING CLEANING OF THE CHEST CAVITY. THE CUSTOMER DID NOT FIND ANY FRAGMENTS. WHEN THE DOCTOR ENTERED THE WOUND CLOSURE, IT WAS DIFFICULT FOR THE SURGEON TO CONFIRM THE DIAPHRAGM SIDE UNDER ROBOT SUPPORT, THE SURGEON WAS PROVIDED WITH INFORMATION REGARDING THE NECESSITY OF RECONFIRMATION AFTER ROLLOUT, AND TO SEARCH THE CHEST CAVITY. RESIDUE WAS UNABLE TO BE CONFIRMED. THE SITE'S SAFETY MANAGER WAS CONSULTED, AND HE PROVIDED INFORMATION RELATED TO THE COMPOSITION OF THE INSTRUMENT. AN X-RAY WAS TAKEN THAT CONFIRMED THAT THERE WERE NO FRAGMENTS AND THE OPERATION WAS COMPLETED. THE CUSTOMER CHECKED THE GAUZE AND MACHINE TABLE THAT WERE USED FOR CLEANING THE INSTRUMENT AND THERE WERE NO MISSING PARTS THAT WERE FOUND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY OR HARM. IT WAS NOTED THAT THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO POSSIBLY 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": "06/10/2023;08/29/2023" } ] }