{ "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": "2955842-2022-13555", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220824", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20220720", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220824", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220331", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1828078", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220824", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "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": "400180", "catalog_number": "400180", "lot_number": "N/A", "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": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Arcing", "Arcing" ], "reporter_state_code": "ME", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/15/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20220824", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "67 YR", "patient_sex": "Male", "patient_weight": "75 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20220720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15283501", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220720", "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": "298490144", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, A SPARK OCCURRED BETWEEN THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND SYNCHROSEAL INSTRUMENT. THE SYNCHROSEAL INSTRUMENT STOPPED WORKING COMPLETELY. THE CUSTOMER REMOVED THE INSTRUMENTS AND OBSERVED CRACKS IN THE BLADE PORTION OF THE SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT REPORTEDLY ARCED DURING THE CASE. THERE WERE CRACKS AND CHAR OBSERVED ON THE INSTRUMENT'S BLADES. THE INSTRUMENTS WERE REPORTEDLY CLOSE TO EACH OTHER DURING THE CASE. IT WAS HARD TO TELL WHERE THE ELECTRICAL ENERGY ARCED TO. THE CUSTOMER REPORTED UNEXPECTED MINOR BLEEDING DURING THE EVENT BUT WAS NOT REALLY SURE WHAT WAS THE CAUSE OF THE BLEEDING. THE CUSTOMER SUSPECTED THAT BLEEDING WAS CAUSED DUE TO THE TIME IT TOOK TO USE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INSTEAD OF THE SYNCHROSEAL INSTRUMENT AS THE SYNCHROSEAL INSTRUMENT SEALS FASTER. THE PATIENT LOST MINIMAL AMOUNT OF BLOOD, AROUND 50CC¿S. NO BLOOD TRANSFUSION WAS NEEDED. HOWEVER, THE BLEEDING WAS RESOLVED WITH THE USE OF BIPOLAR AND MONOPOLAR CAUTERY FROM UNSPECIFIED INSTRUMENTS. THE PATIENT IS REPORTEDLY DOING GOOD." }, { "mdr_text_key": "298490145", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY HAVE NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IN ADDITION, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION (I.E. UNEXPECTED BLEEDING) CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, IT WAS ALLEGED THAT A SPARK OCCURRED BETWEEN A SYNCHROSEAL INSTRUMENT AND A MCS INSTRUMENT. THE ALLEGATION COULD BE RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. IT WAS ALSO ALLEGED THAT THE PATIENT EXPERIENCED UNEXPECTED MINIMAL BLEEDING THAT WAS CONTROLLED BY USING A SPARE DA VINCI INSTRUMENT. THE CAUSES OF THE CUSTOMER REPORTED FAILURE MODE AND INTRA-OPERATIVE COMPLICATION ARE UNKNOWN." }, { "mdr_text_key": "332398996", "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 EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE REPORTED COMPLAINT. FA FOUND THE INSTRUMENT TO HAVE THERMAL DAMAGE ON THE CUT ELECTRODE LOCATED ON THE BOTTOM JAW OF THE GRIP SET. ELECTRICAL CONTINUITY WAS TESTED AND PASSED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION, ENGAGEMENT, AND SELF-CHECK TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. UPON VISUAL INSPECTION, ALL NINE JAW CERAMIC DOTS WERE PRESENT AT THE TIPS. THE INSTRUMENT WAS CONNECTED TO THE E-100 GENERATOR WITHOUT ANY ISSUES. ENERGY DELIVERY TEST WAS PERFORMED AND PASSED. NO SPARKS WERE OBSERVED DURING IN-HOUSE TESTING. A REVIEW OF LOGS SHOWED NO FAILURES. THE GO/NO-GO ELECTRODE GAP SHIM TEST WAS UNABLE TO BE PERFORMED AT THIS TIME DUE TO EFT AVAILABILITY. THE GRIP FORCE TEST WAS PERFORMED AND PASSED WITHIN THE PASSING RANGE OF 3.28 LBS. TO 7.97 LBS. GRIP FORCE TEST INCLUDED STRAIGHT: 4.38, PITCH: 3.97, AND YAW: 4.23. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE DEVICE LOGS FOR THE SYNCHROSEAL (480440-06/L90220404-0341) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE SYNCHROSEAL WAS LAST USED ON (B)(6) 2022 VIA (B)(4). THERE WERE 0 USES REMAINING AFTER THIS LAST USAGE. THIS LAST USAGE OF THE DEVICE WAS BEFORE THE REPORTED EVENT DATE, INDICATING THAT THE DEVICE DID NOT PASS RECOGNITION, OR THE ISSUE WAS IDENTIFIED BEFORE INSTALLATION ON THE REPORTED EVENT DATE." }, { "mdr_text_key": "332398997", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "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": "10/16/2022" } ] }