{ "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": "2955842-2021-11601", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20211124", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20211104", "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": [ "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": "20211124", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210506", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1765104", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211124", "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": "L90210509 0013", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)230531(10)", "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": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/04/2021", "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": "20211124", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20211104", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12872590", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211104", "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": "336652345", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1 B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\" B2 UPDATED TO \"REQUIRED INTERVENTION\" H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." }, { "mdr_text_key": "336652346", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "286060233", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE SYNCHROSEAL INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED COMPLAINTS INVOLVING THIS PRODUCT. THE LOGS SHOW THE CUSTOMER USED THE SYNCHROSEAL INSTRUMENT (PART# 480440-05 LOT# L90210509-0013) ON (B)(6) 2021 ON SYSTEM (B)(4). THIS DEVICE IS A SINGLE-USE INSTRUMENT. THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S ONLY ALLOTTED USAGE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 25902 ¿ ELECTRICAL SURGICAL UNIT (ESU) COMMUNICATION WARNING WITH NEST: CUT START COMMAND RESPONSE TIMEOUT DUE TO MESSAGE DROPPING, AND 23075 ¿ A SURGEONS HAND MAY NOT HAVE BEEN TOUCHING THE LEFT MASTER TOOL MANIPULATOR (MTM) WHILE IN FOLLOWING MODE AT SURGEON SIDE CONSOLE (SSC) 1. REVIEW OF THE PROVIDED IMAGE IS CONSISTENT WITH THE FRAGMENT FALLING INTO THE PATIENT. ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE. BASED ON THE INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT A PIECE OF THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING/MISUSE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY. AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA." }, { "mdr_text_key": "286060234", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED AN ERROR MESSAGE PROMPTING THEM TO INSPECT THE JAWS OF THE SYNCHROSEAL INSTRUMENT DURING THE SYNC OPERATIONS. THE CLINICAL TERRITORY ASSOCIATE (CTA) INFORMED THE TECHNICAL SERVICE ENGINEER (TSE) THE MESSAGE DID NOT APPEAR DURING THE SEAL AND OBSERVED THE MESSAGE ON TWO DIFFERENT INSTRUMENTS. THE CTA THEN STATED THEY HAD THE MESSAGE AND A PIECE OF THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE CUSTOMER WAS ABLE TO RECOVER THE PIECE. THERE WAS NO INJURY REPORTED. THE TSE REVIEWED THE ERROR LOGS AND NOTED A 25902-COMMUNICATION ERROR DURING THE SYNC FUNCTION. THE CUSTOMER POWER CYCLED THE E-100. THE CUSTOMER POWER CYCLED AND EMERGENCY POWER OFF (EPO) THE E-100 AND SYSTEM AS SUGGESTED BY TSE AND THE ISSUE WAS RESOLVED. THE TSE RECOMMENDED THE CUSTOMER TO RETURN THE INSTRUMENT FOR EVALUATION. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ON (B)(4) 2021, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY PRIOR TO THE USE OF THE SYNCHROSEAL INSTRUMENT. THE NURSE INFORMED THE SYNCHROSEAL INSTRUMENT WAS WORKING THROUGH THE WHOLE CASE AND WOULD SHOW AN ERROR FROM TIME TO TIME ON SYNCH. AT THE TIME OF THE REPORTED ISSUE, THE SURGEON PERFORMED THE SYNCH ACTIVATION WHEN THEY OBSERVED AN ¿INSPECT JAWS FOR POSSIBLE DAMAGE. HEMOSTASIS MAY BE COMPROMISED¿ ERROR MESSAGE. THE TARGET TISSUE WERE THE TUBES. THE NURSE STATED THERE WAS NO PARTIAL SEALING OBSERVED. THE NURSE WAS NOT SURE IF THE TARGET TISSUE WAS UNDER TENSION OR IF THE VESSEL WAS GREATER THAN 5MM IN DIAMETER. THERE WAS NO EVIDENCE OF VESSEL CALCIFICATION. IT WAS CONFIRMED THAT THERE WAS TISSUE EFFECT OBSERVED DURING THE SEALING/ SYNC CYCLE. ALL FRAGMENTS WERE RETRIEVED. AN IMAGE WAS PROVIDED TO CONFIRM THAT ALL FRAGMENTS WERE OBTAINED. THERE WERE NO ADDITIONAL SURGICAL PROCEDURE REQUIRED NOR WERE ANY POST-OPERATIVE X-RAYS OR ULTRASOUNDS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE NURSE WAS NOT SURE IF THE THERE WAS ANY INSTRUMENT COLLISION RESULTING IN THE FRAGMENT FALLING. IT WAS UNKNOWN WHAT THE SURGEON BELIEVED CAUSED THE FRAGMENT TO FALL. THE NURSE CONFIRMED THERE WAS NO UNEXPECTED ADDITIONAL BLEEDING EXPERIENCED BY THE PATIENT. A BACKUP INSTRUMENT WAS USED; HOWEVER, THE ERROR MESSAGE OCCURRED. UPON FINAL REMOVAL OF THE INSTRUMENTS, THE WRIST WAS STRAIGHTENED AND NO RESISTANCE WAS FELT THROUGH THE CANNULA. THE STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA OR INSTRUMENT AFTER THE EVENT OCCURRED. THE NURSE WOULD RETURN THE INSTRUMENT WITH THE FRAGMENT. IT WAS UNKNOWN IF THE PATIENT HAD RETURNED TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATION RELATED TO RETAINING A FOREIGN OBJECT. IMAGES OF THE FRAGMENT WERE PROVIDED CONFIRMING THE FRAGMENT THAT FELL INTO THE PATIENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY OR HARM." } ], "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": "05/24/2023" } ] }