{ "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": "2955842-2023-17583", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230808", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20230710", "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": "NIELSON", "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": "20230808", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210809", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2327699", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230808", "brand_name": "DA VINCI ENERGY", "generic_name": "E-100 GENERATOR", "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": "378848", "catalog_number": "378848", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "date_returned_to_manufacturer": "20230714", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874119051", "udi_public": "(01)00886874119051", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/09/2023", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20230808", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20230711", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17483130", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230711", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "335426438", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTION/ADDITIONAL INFORMATION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY, THERE WAS BLEEDING AFTER USING THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WITH THE E-100 GENERATOR. IT WAS LEARNED THROUGH FOLLOW UP WITH THE ROBOTICS COORDINATOR (ROCO) THAT THIS OCCURRED WHILE SEALING IN AN UNSPECIFIC LOCATION IN THE PELVIS AFTER THE INSTRUMENT WAS SUCCESSFULLY USED EARLIER IN THE PROCEDURE. THERE WAS NO TISSUE EFFECT OBSERVED YET THE SURGEON RECEIVED A SEAL COMPLETE MESSAGE. AFTER THE SEAL, THE TISSUE STILL BLED AND THERE WERE NO ERRORS. AN UNSPECIFIED CAUTERY INSTRUMENT WAS USED TO CONTROL THE \"OOZING\" AND ACHIEVE HEMOSTASIS. NO OTHER MEDICAL INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INSUFFICIENT SEAL IS UNKNOWN. CONCOMITANT PRODUCT: VESSEL SEALER EXTEND (VSE) INSTRUMENT - (PART NUMBER: 480422-1 / LOT: L87230531-0034) ADVANCED ENERGY LOGS SHOW THE INSTRUMENT WAS INSTALLED ONCE AND PASSED HOMING ONCE. 22 CUT COMPLETE EVENTS WERE RECORDED WITH NO ERRORS. E-100 LOGS SHOW 23 SEAL EVENTS WITH NO ERRORS. SYSTEM LOGS DON¿T SHOW ANY ERRORS RELATED TO THE FUNCTIONALITY OF THE VESSEL SEALER EXTEND (VSE). THE INSTRUMENT WAS USED FOR A LITTLE OVER 2 MINUTES. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6). FOR SUBMISSION OF A SIMILAR INCIDENT INVOLVING THIS E-100 GENERATOR THAT OCCURRED THE NEXT DAY. THE PRIMARY PRODUCT WAS ALSO RECEIVED UNDER PATIENT IDENTIFIER (B)(6)." }, { "mdr_text_key": "335426439", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "320652565", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE SURGEON REPORTED BLEEDING AFTER SEALING WITH THE VESSEL SEALER. THE CSR REPORTED THAT THE SURGEON WAS ABLE TO CONTROL BLEEDING AND THAT THERE WAS NO PATIENT INJURY. THE CSR STATED THAT SURGEON WAS USING THE VESSEL SEALER VIA THE E-100 GENERATOR. THE CSR REPORTED THAT THE ISSUE ALSO OCCURRED THE PREVIOUS DAY. THE CSR STATED THERE WAS A CASE TO FOLLOW AND THAT THE SITE WOULD BE USING THE VESSEL SEALER WITH THE INTEGRATED ELECTROSURGICAL UNIT (ERBE) GENERATOR. THE TSE RECOMMENDED THAT SITE RMA AFFECTED INSTRUMENTS AND CALL BACK IN THE ISSUE RETURNS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY." }, { "mdr_text_key": "320652566", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SEALING ISSUES WITH THE ELECTROSURGICAL GENERATOR, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED PROBLEM. THE FSE REPLACED THE E-100 GENERATOR TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE E-100 GENERATOR FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPLICATED. THIS E-100 GENERATOR WAS INSTALLED INTO THE TEST SYSTEM, AND IT WORKED FINE WITH SYNCHRO SEAL INSTRUMENT INSTALLED. THE SYNCHRO SEAL WAS USED WITH A SALINE DIPPED GAUZE IN THE JAWS AND FIRED YELLOW PEDAL/SYNC ACTIVATIONS CUT/SEAL ABOUT 100 TIMES AND E-100 WORKED FINE WITHOUT ANY ISSUE. THE COMPLAINT REGARDING SEALING ISSUES WITH E-100 WAS NOT CONFIRMED BASED ON THE FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THE ISSUE IS UNKNOWN. THE FAILURE ANALYSIS AND FIELD EVALUATION COULD NOT REPLICATE THE REPORTED ISSUE. THE E-100 GENERATOR WORKED FINE WITHOUT ANY ISSUES WITH WORKED FINE WITH SYNCHRO SEAL INSTRUMENT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE." } ], "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": "09/01/2023" } ] }