{ "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": "2955842-2021-10970", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210822", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210726", "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": "WANG", "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": "20210822", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20210122", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1249358", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210822", "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": "L91210126 0018", "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)230131(10)L91210126", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/17/2021;07/27/2021", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20210822", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "37 YR", "patient_sex": "Female", "patient_weight": "119 KG", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210727", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12351979", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210727", "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": "267647239", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SYNCHROSEAL INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY OTHER COMPLAINTS INVOLVING THIS PRODUCT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE SYNCHROSEAL INSTRUMENT (PART NUMBER: 480440-5, LOT NUMBER: L91210126-0018) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON 26-JULY-2021 ON SYSTEM (B)(4) FOR 7 MINUTES. THE INSTRUMENT IS A SINGLE-USE AND IT WAS NOT USED IN A SUBSEQUENT PROCEDURE. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A ¿SMALL RIVET¿ FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED DURING THE SAME PROCEDURE AND THE SURGEON DISCONTINUED USING THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. ALTHOUGH THERE WAS NO PATIENT INJURY, AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED, UNINTENDED ITEMS FALLING INTO THE PATIENT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE PIECE TO FALL FROM THE INSTRUMENT." }, { "mdr_text_key": "267647240", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A ¿SMALL RIVET¿ FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE AND THE SURGEON DISCONTINUED USING THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ON 28-JULY-2021. THE INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT WAS USED FOR APPROXIMATELY 10 MINUTES. THE SURGEON WAS DISSECTING BY THE HIATUS WHEN THE INSTRUMENT BROKE. THE BROKEN FRAGMENT WAS RETRIEVED BY USING A LAPAROSCOPIC GRASPER. ALL FRAGMENTS WERE RETRIEVED AND IT WAS CONFIRMED VISUALLY. NO POST-OPERATIVE TESTS WERE PERFORMED." }, { "mdr_text_key": "328482960", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 17-SEPT-2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT 0500690000-2021-8026 STATING: \"SMALL RIVET FELL OFF EQUIPMENT INTO THE PATIENT. RIVET RECOVERED AND REMOVED. NO PATIENT HARM.\" IT WAS ALSO NOTED THAT THE INTENDED PROCEDURE WAS, \"SLEEVE GASTRECTOMY\". FOLLOW-UP: ON 20-JAN-2022, ISI CONTACTED THE ASSOCIATED CLINICAL DATA ANALYST AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT: THIS USER FACILITY REPORT IS FOR THE SAME EVENT REPORTED UNDER THE INITIAL REPORT WITH PATIENT IDENTIFIER (B)(6)." }, { "mdr_text_key": "336866121", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336866122", "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. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1: B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO \"REQUIRED INTERVENTION\". H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." } ], "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": "02/19/2022;05/24/2023" } ] }