{ "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": "2955842-2021-11627", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20211130", "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": "PHYSICIAN", "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": "20211130", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20201125", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1791958", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211130", "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": "T91201125 0112", "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)221130(10)T91201125", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Difficult to Open or Close", "Difficult to Open or Close" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/04/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20211130", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "Black Or African American", "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": "12889404", "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": "329255574", "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 DUE TO THE SYNCHROSEAL INSTRUMENT THAT WAS CLAMPED ON TISSUE AND COULD NOT BE REMOVED. ALTHOUGH THE SURGEON SAID, THEY ¿FORGOT THAT THERE WAS A KEY TO RELEASE THE INSTRUMENT AND INSTEAD CUT THROUGH THE TISSUE TO REMOVE THE INSTRUMENT¿. B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\" B2 UPDATED TO INCLUDE ¿REQUIRED INTERVENTION¿ ANNEX F UPDATED TO INCLUDE F1906 DUE TO THE REPORT OF ¿CUT TISSUE¿. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1 UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: B2, G6, H2 AND H6." }, { "mdr_text_key": "329255575", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "286007371", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ISI FIELD SERVICE ENGINEER (FSE) CONTACTED THE OPERATING ROOM (OR) CHARGE NURSE, AND WAS INFORMED THAT THE SYSTEM WAS IN USE ALL DAY FRIDAY AND THEY HAVE BEEN USING THE SYSTEM WITH NO ISSUES. THE CUSTOMER PLANNED TO RETURN THE INSTRUMENT AND WOULD CONTACT TECHNICAL SUPPORT IF THEY HAD ANY ADDITIONAL ISSUES. 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. INSTRUMENT LOGS SHOW THAT THE CUSTOMER USED THE FOLLOWING TWO SYNCHROSEAL INSTRUMENTS ON (B)(6) 2021 WITH SYSTEM (B)(4): SYNCHROSEAL INSTRUMENT PART # 480440-05 LOT # T91201125-0112. THIS DEVICE IS A SINGLE-USE INSTRUMENT AND THEREFORE ONLY HAS ONE USE ALLOTTED TO IT. THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S ONLY ALLOTTED USAGE. SYNCHROSEAL INSTRUMENT PART # 480440-05 LOT # L90200818-0028. THIS DEVICE WAS USED FOR 0 MINUTES AND THEREFORE WAS NOT EXPIRED AT THE TIME OF THE REPORTED EVENT. A REVIEW OF THE SYSTEM LOGS FOR THE SYNCHROSEAL INSTRUMENT PART # 480440-05 LOT # T91201125-0112 AND SYNCHROSEAL INSTRUMENT PART # 480440-05 LOT # L90200818-0028 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE TOOL TABLE SHOWS INSTRUMENT -0028 WAS USED FOR 0 MINUTES. THE ONLY RECORDED SYNCHROSEAL USE IS WITH INSTRUMENT -0112. THERE WERE NO ERRORS OR RELEVANT MESSAGES RECORDED IN THE E-100 GENERATOR LOGS FOR THE SYNCHROSEAL THAT WAS USED. THERE WERE NO RELEVANT ERRORS IN THE MSC LOGS. THE E-STOP (EMERGENCY STOP) WAS NOT PRESSED DURING THIS PROCEDURE. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. 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 SYNCHROSEAL INSTRUMENT FAILED TO UNCLAMP. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE INSTRUMENT FAILS TO UNCLAMP/RELEASE FROM TISSUE WHEN COMMANDED BY THE USER OR SYSTEM. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE UNCLAMPING EVENT TO OCCUR. 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": "286007372", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS FIRED AND THE JAWS FROZE ON THE PATIENT'S TISSUE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICES ENGINEER (TSE) REVIEWED THE LOGS AND FOUND ERROR 32058 ON ARM 3. THE STAFF REBOOTED THE SYSTEM AND IT CAME UP WITH NO ERRORS OR INJURY TO THE PATIENT. THE CUSTOMER CONTINUED WITH THE CASE AND PLANNED TO RETURN THE INSTRUMENT. THERE WAS NO REPORTED INJURY. ON 05-NOV-2021, ISI FOLLOWED UP WITH THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CTA CONFIRMED THAT HE WAS NOT PRESENT DURING THE REPORTED CASE; HOWEVER, WAS INFORMED BY THE NURSE. THE CUSTOMER DID NOT REPORT ANY SEALING RELATED TO THE ERROR MESSAGE. ON 12-NOV-2021 AND 15-NOV-2021, ISI FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS ASKED IF THEY HAD OBSERVED ANY PARTIAL SEAL/HOLES AS THE INSTRUMENT JAWS WERE FROZEN, TO WHICH THE SURGEON SAID THEY DID NOT KNOW IF IT HAD COMPLETED THE SEAL OR NOT. AS A RESULT, THE SURGEON SAID THEY ¿FORGOT THAT THERE WAS A KEY TO RELEASE THE INSTRUMENT AND INSTEAD CUT THROUGH THE TISSUE TO REMOVE THE INSTRUMENT¿. THE SURGEON REPORTED THAT THIS TISSUE, \"LESS THAN 2MM\" IN SIZE, WAS NOT GOING TO BE CUT, PER THE SURGICAL PLAN, BUT THAT IT WAS ATTACHED TO THE UTERUS, WHICH WAS GOING TO BE REMOVED AS PART OF THIS HYSTERECTOMY PROCEDURE. THE SURGEON DESCRIBED THE TISSUE THAT WAS REMOVED AS ¿AVASCULAR TISSUE¿ AND COULD BE CUT WITHOUT ANY ENERGY. THE SURGEON SAID, ¿THERE WAS NO BLOOD OBSERVED AS THE SYNCHROSEAL INSTRUMENT HAD SEALED AND CUT; HOWEVER, THE JAWS WOULD NOT OPEN.¿ SINCE THE JAWS WERE CLAMPED ON TISSUE THAT WAS ON THE SIDE OF THE UTERUS THAT WAS GOING TO BE REMOVED, THE SURGEON ELECTED TO CUT AND RELEASE THE INSTRUMENT. THE SURGEON WAS ASKED IF ANY SUTURES OR STAPLES WERE APPLIED TO REPAIR THE CUT TISSUE, TO WHICH THE SURGEON RESPONDED NO. THE SYSTEM WAS RESTARTED AND A SECOND SYNCHROSEAL INSTRUMENT WAS INSTALLED; HOWEVER, THE SAME ERROR MESSAGE INDICATING ¿TO CHECK THE INSTRUMENT JAWS. HEMOSTASIS MAY BE COMPROMISED¿ APPEARED. THE SURGEON THEN ELECTED TO CONTINUE THE CASE WITH A VESSEL SEALER (VS) INSTRUMENT. IT WAS UNKNOWN IF THE SYNCHROSEAL INSTRUMENT WOULD BE RETURNING FOR REVIEW. THE PATIENT HAD NOT RETURNED TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS RELATED TO THE PROCEDURE. THERE WAS NO IMAGE/VIDEO IMAGE AVAILABLE. 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": "06/27/2022" } ] }