{ "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": "2955842-2021-11721", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20211210", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20211110", "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": "20211211", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200708", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1872623", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211210", "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", "expiration_date_of_device": "20220731", "model_number": "480440-05", "catalog_number": "480440", "lot_number": "T91200708 0128", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20211130", "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)220731(10)T91200708", "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", "Device Dislodged or Dislocated", "Detachment of Device or Device Component", "Device Dislodged or Dislocated" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/15/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20211210", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "75 YR", "patient_sex": "Male", "patient_weight": "60 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "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": "20211115", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12981038", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211115", "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": "335847322", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335847323", "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." }, { "mdr_text_key": "284450704", "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 WAS FOUND TO HAVE PART OF THE TIP FELL INTO THE PATIENT. THE CUSTOMER RETRIEVED THE FRAGMENT IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. DURING A DA VINCI-ASSISTED THYMECTOMY SURGICAL PROCEDURE, THE SURGEON USED THE INSTRUMENT FOR 10 MINUTES FOR DISSECTING THE TISSUE AND NOTICED FRAGMENT FROM THE INSTRUMENT. ALL THE FRAGMENTS WERE RETRIEVED DURING SAME PROCEDURE WITH THE MARYLAND BIPOLAR FORCEPS. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR AS THE CUSTOMER DID NOT NOTICE ANY COLLISION. THERE WAS NO PATIENT INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. BOTH INSTRUMENT AND CANNULA HAD NO OTHER DAMAGE AFTER THE EVENT OCCURRED. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." }, { "mdr_text_key": "284450705", "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 REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF INSTRUMENT WASHER DISLODGED -DISTAL TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE ONE OF THE PIVOT PIN WASHERS DISLODGE AT THE DISTAL END. THE DISLODGED WASHER WAS RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND PASSED THE INITIALIZATION TEST AND THE ENERGY DELIVERY TEST. THE INSTRUMENT WAS TRANSFERRED TO ENGINEERING FOR FURTHER REVIEW. INSTRUMENT PIVOT PIN WASHER WAS FOUND TO BE DISLODGED. SMALL INDENTATIONS WERE FOUND AROUND THE OUTER CIRCUMFERENCE OF THE SWAGED END OF THE PIVOT PIN, AS WELL AS ON THE FACE OF THE DISLODGED PIVOT PIN WASHER. THIS EVIDENCE SUGGESTS THE WASHER WAS LIKELY DISLODGED DUE TO COLLISION OR MISHANDLING OF THE INSTRUMENT. ADDITIONALLY, WHILE SWAGING OF THE PIVOT PIN WAS COMPLETED, THE PIVOT PIN SWAGE WAS FOUND TO BE SLIGHTLY OFF-AXIS. THE PIVOT PIN WAS SECURE WITHIN THE INSTRUMENT JAWS. THIS FINDING CAN BE ATTRIBUTED TO MANUFACTURING. TEARS IN THE JAW COVER WERE FOUND IN THE POUCH AND ON THE PROXIMAL SIDE TYPICALLY ATTRIBUTED TO THE MISHANDLING/MISUSE. A REVIEW OF THE INSTRUMENT LOG FOR THE SYNCHROSEAL INSTRUMENT (PART # 480440-05/ LOT# T91200708 0128) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS USED ON (B)(6) 2021, ON SYSTEM (B)(4). THE IS A SINGLE- USE INSTRUMENT. IN ADDITION, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT OR THIS EVENT. A DEVICE IMAGE FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. IT APPEARED THAT ONE OF THE DISTAL PIVOT PIN WASHERS HAS DISLODGED FROM THE INSTRUMENT. TYPICALLY, A DISLODGED PIVOT PIN WASHER IS ATTRIBUTED TO USER MISHANDLING, SUCH AS COLLISIONS OR IMPROPER INTRAOPERATIVE CLEANING HOWEVER, CLEAR SIGNS OF MISHANDLING OR MISUSE CANNOT BE DETECTED FROM THE PHOTOS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE INSTRUMENT'S PIVOT PIN WAS DISLODGED AND FELL INTO THE PATIENT WITH NO EVIDENCE OF USER MISHANDLING/MISUSE. THIS INSTRUMENT IS DESIGNED WITH A PIVOT PIN ON THE DISTAL END ALLOWING ARTICULATION OF THE INSTRUMENT ASSEMBLIES THEY ARE HOLDING TOGETHER AND IS SECURED TO THE DEVICE BY SWAGING. IF THE PIN IS NOT PROPERLY FUSED TOGETHER, THE PIN COULD BECOME DISLODGED AND FALL INTO THE PATIENT. 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. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE." } ], "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" } ] }