{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2018-10549", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20180926", "manufacturer_address_2": "", "pma_pmn_number": "K110639", "date_of_event": "20180827", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20180926", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "749689", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180926", "brand_name": "ENDOWRIST; DA VINCI SI", "generic_name": "VESSEL SEALER", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "410322-05", "catalog_number": "", "lot_number": "M10180125 920", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "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", "Failure to Deliver Energy" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/27/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250807", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20180926", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20180827", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7910086", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20180827", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "121744754", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE VESSEL SEALER INSTRUMENT WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS DID NOT CONFIRM THE CUSTOMER REPORTED COMPLAINT OF A CAUTERY ISSUE. THE INSTRUMENT DID NOT EXHIBIT ANY CONDUCTOR WIRE DAMAGE. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE DA VINCI SYSTEM FOR FUNCTIONAL TESTING. THE INSTRUMENT PASSED A SELF-TEST AND ENERGY WAS DELIVERED WITHOUT ANY ISSUES. THE INSTRUMENT ALSO PASSED A GAP TEST WITH THE 0.000\" GAUGE. THE ELECTRICAL CONTINUITY TESTING PASSED. THE SYSTEM LOGS DID NOT SHOW ANY FAILURES. THE ERBE GENERATOR WAS RETURNED TO ISI AND EVALUATED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND RAN IN DIAGNOSTIC MODE. DURING THE EVALUATION, NO ERRORS WERE GENERATED. THE UNIT ENERGIZED, CAUTERIZED, AND RECOGNIZED INSTRUMENTS. NO ISSUES OCCURRED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2018. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER ALLEGEDLY FAILED TO SEAL THE IMA AND BLEEDING ENSUED AFTER A CUT FUNCTION WAS PERFORMED. AS A RESULT, THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY IN ORDER TO CONTROL THE BLEEDING." }, { "mdr_text_key": "121744755", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING THE DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, A VESSEL SEALER INSTRUMENT WAS ALLEGEDLY NOT SEALING. AT THE TIME THE INITIAL REPORTER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE SURGICAL STAFF HAD ALREADY CONVERTED THE SURGICAL PROCEDURE TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF PULLED THE VESSEL SEALER INSTRUMENT OUT AND CLAIMED THAT THE INSTRUMENT WOULD HEAT UP ON A CLOTH. HOWEVER, WHEN THE VESSEL SEALER INSTRUMENT WAS REINSERTED BACK INTO THE PATIENT, IT WAS ALLEGED THAT THE INSTRUMENT WOULD NOT SEAL A VESSEL. THE INITIAL REPORTER INDICATED THAT THE VESSEL IN QUESTION SEEMED TO BE NORMAL IN SIZE. THE INITIAL REPORTER ALSO CLAIMED THAT WHEN THE EVENT OCCURRED, THE AUDIBLE TONES INDICATING THAT THE SEALING CYCLE WAS COMPLETE WERE HEARD. THE TSE CHECKED THE SYSTEM LOGS AND DID NOT FIND ANY RELATED SYSTEM ERRORS. ON (B)(6) 2018, ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON HAD REPORTEDLY TESTED THE VESSEL SEALER INSTRUMENT ON FAT TISSUE TO CONFIRM ENERGY DELIVERY PRIOR TO ATTEMPTING TO SEAL THE INFERIOR MESENTERIC ARTERY (IMA). THE INITIAL REPORTER STATED THAT THE IMA WAS THE FIRST VESSEL THAT THE SURGEON HAD ATTEMPTED SEAL AND CUT WITH THE VESSEL SEALER INSTRUMENT. THE VESSEL WAS NOT LARGER THAN 7 MM. THERE WAS NO OBSERVABLE VESSEL CALCIFICATION, TISSUE TENSION, OR BIO-DEBRIS BETWEEN THE INSTRUMENT¿S TIPS WHEN THE EVENT OCCURRED. TISSUE EFFECT WAS SEEN DURING THE SEALING CYCLE. IN ADDITION, THE INITIAL REPORTER CONFIRMED THAT THE AUDIBLE TONES WERE HEARD, INDICATING THAT A SUCCESSFUL SEAL WAS COMPLETED. THERE WERE NO ERROR MESSAGES. AFTER PERFORMING THE CUT FUNCTION WITH THE VESSEL SEALER INSTRUMENT, BLEEDING WAS OBSERVED. THE SURGEON ATTEMPTED UNSUCCESSFULLY TO CONTROL THE BLEEDING BY SEALING THE RIGHT SIDE OF THE CUT. AT THAT POINT, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY VIA OPEN SURGERY. ON 08/29/2018, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE VERIFIED THAT ALL CABLE TENSIONS AND GRIP CALIBRATIONS WERE WITHIN SPECIFICATIONS. THE FSE WAS ABLE TO FIRE A VESSEL SEALER EMULATOR INSTRUMENT WITHOUT ANY ISSUES. THE FSE WAS UNABLE TO REPLICATE THE ALLEGED SEALING ISSUE. THE FSE REPLACED THE ERBE GENERATOR AS A PRECAUTION." }, { "mdr_text_key": "282031448", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INSTRUMENT ALSO PASSED A GAP TEST WITH THE 0.001\" GAUGE, NOT WITH A 0.000\" GAUGE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/22/2019" } ] }