{ "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": "2955842-2021-10021", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210111", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20201216", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20210111", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200213", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "45955", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210111", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480440-05", "catalog_number": "480440", "lot_number": "T90200213", "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)220228(10)T90200213", "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": "NH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/16/2020", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250804", "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": "20210111", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20201216", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11150336", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201216", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "268091702", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SYNCHROSEAL 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 SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED TO ISI FOR REVIEW. SYNCHROSEAL CONSISTS OF A SINGLE-USE, DISPOSABLE, 8 MM INSTRUMENT WITH AN INTEGRATED CORD THAT CONNECTS TO THE E-100 ELECTROSURGICAL GENERATOR. THE ELECTRODE-SEALING SURFACE EXTENDS TOWARD THE DISTAL AND PROXIMAL ENDS OF THE JAW AND IS TEXTURED ON ONE SIDE WITH CERAMIC SPACERS. THE MOVEABLE SIDE OF THE JAW CONTAINS A CUT ELECTRODE TO ENABLE TRANSECTION. THE STATIONARY SIDE OF THE JAW CONTAINS A BLUE SPRING PAD THAT ENABLES TISSUE CONTACT WITH THE CUT ELECTRODE DURING TRANSECTION. THE INSTRUMENT ALSO INCLUDES AN INTEGRATED JAW COVER. A SLIDER ON THE HOUSING ALLOWS THE USER TO MANUALLY OPEN AND CLOSE THE INSTRUMENT JAWS FOR INTRAOPERATIVE CLEANING AND GRIP RELEASE. A LOCK BUTTON ON THE HOUSING ALLOWS THE USER TO LOCK THE JAWS OPEN FOR INTRAOPERATIVE CLEANING. TWO RELEASE BUTTONS ON THE HOUSING ALLOW THE USER TO REMOVE SYNCHROSEAL FROM THE STERILE ADAPTER ON THE INSTRUMENT ARM. THE DISCS CONNECT TO THE INSTRUMENT WRIST AND TRANSLATE THE MOVEMENTS OF THE HAND CONTROLS FROM THE SURGEON CONSOLE. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE A PLASTIC PART OF THE SYNCROSEAL JAW FELL OFF WHILE THE INSTRUMENT WAS IN THE SURGICAL FIELD. THE OR STAFF WAS ABLE TO REMOVE THE PIECE FROM THE PATIENT WITHOUT ANY ISSUES AND THERE WAS NO REPORT OF PATIENT INJURY. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "268091703", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PLASTIC PART OF THE SYNCROSEAL JAW FELL OFF WHILE THE INSTRUMENT WAS IN THE SURGICAL FIELD. THE OPERATING ROOM (OR) STAFF WAS ABLE TO REMOVE THE PIECE FROM THE PATIENT WITHOUT ANY ISSUES AND THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) COMPLETED FOLLOW-UP AND OBTAINED THE FOLLOWING INFORMATION: PER THE REPORTER, ALL FRAGMENTS WERE RETRIEVED USING A LAPAROSCOPIC GRASPER. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT NOR WERE THERE ANY POST-OPERATIVE TESTS PERFORMED. THE SURGEON WAS USING THE MONOPOLAR CURVED SCISSORS TO CLEAN TISSUE OFF THE SYNCHROSEAL WHEN THE REPORTED ISSUE OCCURRED. THE INSTRUMENT WAS REMOVED PROPERLY AND THERE WAS NO REPORT OF PATIENT INJURY, NOR HAS THE PATIENT RETURNED TO THE HOSPITAL DUE TO POST-OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "336227829", "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." }, { "mdr_text_key": "336227830", "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": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/24/2023" } ] }