{ "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": "2955842-2022-10274", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220218", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220114", "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": [ "Other", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220218", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210915", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "538294", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220218", "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": "L91210921 0098", "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": "10886874117306", "udi_public": "(01)10886874117306(17)230930(10)L91210921", "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": "IA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/03/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250822", "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": "20220218", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "77 YR", "patient_sex": "Male", "patient_weight": "70 KG", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20220125", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13558194", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220125", "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": "285814013", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE SYNCHROSEAL INSTRUMENT FOR EVALUATION, ALTHOUGH IT IS EXPECTED TO BE RETURNED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE INSTRUMENT LOG OF THE SYNCHROSEAL (PART # 480440-05 / LOT # L91210921-0098) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS USED ON (B)(6) 2022 ON SYSTEM SK1431. THIS IS A SINGLE USE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY SHOWS NO OTHER EVENTS REPORTED FOR THIS INSTRUMENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED RIGHT NATIVE NEPHRECTOMY SURGICAL PROCEDURE, IT WAS ALLEGED THE CUSTOMER NOTICED A MISSING SECTION OF THE SYNCRHOSEAL INSTRUMENT WHEN THEY REMOVED IT FROM THE PATIENT. THE CUSTOMER SEARCHED INSIDE THE PATIENT FOR THE FRAGMENT AND AN X-RAY WAS TAKEN, BUT THE FRAGMENT COULD NOT BE FOUND. THE FRAGMENT WAS NOT RETRIEVED AND WAS RETAINED INSIDE THE PATIENT'S ANATOMY." }, { "mdr_text_key": "285814014", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 25-JAN-2022, INTUITIVE SURGICAL, INC (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: \"PATIENT WAS UNDERGOING A ROBOTIC ASSISTED LAPAROSCOPIC RIGHT NATIVE NEPHRECTOMY. THE SURGEON USED AN 8 MM SYNCHOSEAL CAUTERY/LIGATION DEVICE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED TO BE MISSING A SECTION OF THE GRASPER HOUSING. THE PROVIDER SEARCHED INSIDE THE PATIENT FOR THE FRAGMENT AND AN X-RAY WAS TAKEN. THE X-RAY DID NOT IDENTIFY ANY FOREIGN MATTER, BUT THE RADIOLOGIST NOTED PLASTIC WOULD NOT SHOW UP ON X-RAY.\" IT WAS ALSO REPORTED BY THE CUSTOMER TO INTUITIVE SURGICAL, INC. (ISI) THAT DURING A DA VINCI-ASSISTED RIGHT NATIVE NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTICED A MISSING SECTION OF THE SYNCRHOSEAL INSTRUMENT WHEN THEY REMOVED IT FROM THE PATIENT. THEY SEARCHED INSIDE THE PATIENT FOR THE FRAGMENT AND AN X-RAY WAS TAKEN. THE X-RAY DID NOT DETECT ANY FOREIGN MATTER, BUT THE RADIOLOGIST NOTED THAT PLASTIC WOULD NOT SHOW UP ON AN X-RAY. ON 04-FEB-2022, ISI CONTACTED ORIGINAL REPORTER FROM THE USER FACILITY REPORT AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT. SHE DID NOT KNOW HOW LONG THE INSTRUMENT WAS IN USE WHEN THE ISSUE OCCURRED. THE FRAGMENT WAS NEVER RECOVERED. THE SURGEON SAID CONVERTING THE PROCEDURE TO AN OPEN SURGERY TO FIND THE FRAGMENT WAS NOT WORTH THE RISK TO THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. SHE WAS NOT AWARE IF THE PATIENT HAD RETURNED DUE TO ANY POST OPERATIVE COMPLICATIONS DUE TO THIS ISSUE. THE INSTRUMENT WILL BE RETURNED TO ISI." }, { "mdr_text_key": "328644051", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "328644052", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D11: INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) WAS ABLE TO CONFIRM/REPRODUCE THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN OVERMOLD OF ONE OF THE GRIP TIPS. THE BROKEN PIECE APPROXIMATELY 0.098\" X 0.421\" IN SIZE WAS NOT RETURNED WITH THE INSTRUMENT. ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. NO CERAMIC DOTS WERE MISSING. A REVIEW OF THE LOG SHOWS NO ERRORS. THE ROOT CAUSE WAS ATTRIBUTED TO MISHANDLING/MISUSE." } ], "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": "04/02/2022" } ] }