{ "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": "2955842-2022-14120", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20220922", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220818", "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", "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": "20220922", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220707", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2693970", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220922", "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": "L10220711", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20220907", "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)240731(10)L10220711", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Deliver Energy", "Arcing", "Failure to Deliver Energy", "Arcing" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/22/2022;10/04/2022", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20220922", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20220822", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15466462", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20220822", "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": "300405249", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY THE USER EXPERIENCED AN INCOMPLETE SEAL USING THE SYNCHROSEAL INSTRUMENT (LOT #L10220711-0413) AND ENCOUNTERED AN ¿INSPECT JAWS FOR DAMAGE¿ ERROR MESSAGE. A SECOND SYNCHROSEAL INSTRUMENT (LOT #L10220711-0396) WAS INSTALLED BUT ALSO DISPLAYED THE SAME ERROR MESSAGE. AS A RESULT, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY IN ORDER TO CONTROL BLEEDING. THERE WAS NO PATIENT HARM REPORTED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "300405250", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. ISI HAS RECEIVED THE SYNCHROSEAL INSTRUMENT (LOT #L10220711-0396) INVOLVED WITH THE REPORTED EVENT AND COMPLETED INVESTIGATIONS. 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 JAWS OPENED AND CLOSED PROPERLY. ELECTRICAL CONTINUITY WAS TESTED AND PASSED. UPON VISUAL INSPECTION, ALL 9 JAW CERAMIC DOTS WERE PRESENT AT THE TIPS. THE INSTRUMENT WAS CONNECTED TO THE E-100 GENERATOR AND WAS TESTED FOR ENERGY DELIVERY. NO SEALING ISSUES WERE OBSERVED DURING IN-HOUSE TESTING. THE GRIP FORCE TEST WAS PERFORMED AND PASSED. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE CUT ELECTRODE LOCATED ON THE BOTTOM JAW OF THE GRIP SET. THE INSTRUMENT WAS FOUND TO HAVE A TORN JAW COVER. A PIECE MEASURING APPROXIMATELY 0.262\" X 0.575\" IN SIZE WAS NOT RETURNED WITH THE INSTRUMENT. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO THE USER. THE INSTRUMENT WAS FOUND TO HAVE DEEP SCRATCHES ON THE BASE OF THE GRIPS. NO MATERIAL APPEARS TO BE MISSING. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO THE USER. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE SYSTEM LOGS WERE REVIEWED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). PER THE FAE, BOTH SYNCHROSEAL INSTRUMENTS EXPERIENCED INTERMITTENT ¿CUT ELECTRODE SHORTAGE¿ FAILURES DURING THE CASE. THIS ERROR IS LIKELY DUE TO TOO MUCH FLUID IN BETWEEN THE JAWS OR TISSUE STUCK ON THE JAWS WHEN ENERGY IS ACTIVATED. AFTER ENCOUNTERING THE FAILURES, THE INSTRUMENTS WERE ABLE TO CUT AND SEAL SUCCESSFULLY. NO VIDEO/IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY, THE SYNCHROSEAL INSTRUMENT DID NOT SUFFICIENTLY COMPLETE A SEAL. IN ORDER TO CONTROL BLEEDING, THE SURGEON ELECTED TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY. THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER #(B)(6) FOR MDR SUBMISSION OF THE 1ST SYNCHROSEAL INSTRUMENT (LOT #L10220711-0413) INVOLVED WITH THE REPORTED EVENT." }, { "mdr_text_key": "331688001", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "331688002", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H7, H9, AND H10. CORRECTED DATA CAN BE FOUND IN FIELDS H7 AND H9. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ACCORDING TO THE INITIAL REPORTER, AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO DISSECT TISSUE WHICH HAD EXCESS MOISTURE AND BLEEDING OCCURRED. AS A RESULT, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY IN ORDER TO CONTROL THE BLEEDING. THE BLEEDING WAS DESCRIBED AS BEING MILD TO MODERATE AND THE ESTIMATED BLOOD LOSS WAS 50 CC. PER THE SURGEON, THE INSTRUMENT FUNCTIONED PROPERLY FOR ONE HOUR AT WHICH POINT THE CUSTOMER EXPERIENCED IMPROPER/INCOMPLETE SEALING AND TISSUE STICKING TO THE INSTRUMENT JAWS. THERE WAS MINIMAL TO NO TENSION ON THE LUNG VESSEL BEING SEALED. NO EVIDENCE OF VESSEL CALCIFICATION WAS NOTED. THE VESSEL WAS NOT GREATER THAN 5MM IN DIAMETER. TISSUE EFFECT WAS OBSERVED DURING THE SEALING CYCLE(S). THE INSTRUMENT JAWS DID NOT COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS WHEN THE REPORTED ISSUE WAS NOTED." }, { "mdr_text_key": "333227923", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT WAS FURTHER INVESTIGATED BY A FAILURE ANALYSIS ENGINEER (FAE). THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED ENGAGEMENT, INTUITIVE MOTION, AND ENERGY DELIVERY TESTS. HOWEVER, AFTER REVIEWING THE E-100 LOGS, THERE WERE MULTIPLE \"CUT ELECTRODES SHORTED\" ERRORS THAT HAD OCCURRED DURING THE PROCEDURE. THESE ERRORS COUPLED WITH THE THERMAL DAMAGE THAT WAS INSPECTED ON THE CUT ELECTRODE INDICATE AN ARCING EVENT WHICH, IN THIS CASE, SHORTED THE ELECTRODE. WHEN THE ELECTRODE WAS SHORTED THE MESSAGE OF \"INSPECT JAWS FOR DAMAGE\" THEN APPEARED TO THE USER, THUS CONFIRMING THE CUSTOMER'S COMPLAINT. THIS IS A COMPONENT RELATED FAILURE." } ], "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": "09/23/2022;10/31/2022" } ] }