{ "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": "2955842-2022-12515", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220628", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20200506", "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": "20220628", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2017283", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220628", "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": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": [ "Arcing", "Arcing" ], "reporter_state_code": "NV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "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": "20220628", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "48 YR", "patient_sex": "Female", "patient_weight": "63 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "No Clinical Signs, Symptoms or Conditions", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20200507", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14847807", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200507", "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": "294912788", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE REPORT OF THE SYNCHROSEAL INSTRUMENT ARCING AT THE JAWS CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THIS EVENT FOR FAILURE ANALYSIS (FA) EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A REVIEW OF THE SUBMITTED IMAGE AND VIDEO WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: BASED ON THE VIDEO PROVIDED, VISUAL ARCING WAS CONFIRMED AT THE TWO SECOND MARK AND NINE (9) SECOND MARK. ARCING DAMAGE AT THE JAW WAS CONFIRMED BASED ON REVIEW OF THE IMAGE PROVIDED. INSTRUMENT LOG REVIEW COULD NOT BE PERFORMED AS THE DA VINCI SYSTEM WAS NOT ONLINE ON THE PROCEDURE DATE OF 06-MAY-2020. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON NOTED THAT THE SYNCHROSEAL INSTRUMENT ARCED AT THE JAWS. THE GENERATOR DID NOT SHUT OFF DUE TO THE REPORTED ARCING INCIDENT, BUT DAMAGE WAS NOTED BETWEEN THE JAWS OF THE INSTRUMENT. THE PATIENT CODED DURING THE PROCEDURE AND REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO REPORT OF INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT." }, { "mdr_text_key": "294912789", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON NOTED THAT THE SYNCHROSEAL INSTRUMENT ARCED AT THE JAWS. THE SURGEON BELIEVED THAT IT WAS TRIGGERED BY A THICK, ROUND, LIGAMENT OF TISSUE. THE GENERATOR DID NOT SHUT OFF DUE TO THE REPORTED ARCING INCIDENT, BUT DAMAGE WAS NOTED BETWEEN THE JAWS OF THE INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY WITH NO REPORTED INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON, REGARDING THE REPORTED EVENT: THE SURGEON CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT WAS INSPECTED AT THE BEGINNING OF THE CASE AND NO DAMAGE WAS NOTED. THE ARCING EVENT WAS NOTED AFTER ABOUT FIVE MINUTES OF USE. THE SURGEON BELIEVED THAT THE ARCING EVENT OCCURRED DUE TO THE JAWS NOT CLOSING COMPLETELY ON A THICKER PORTION OF TISSUE. THE SURGEON CONFIRMED THAT THE INSTRUMENT WAS NOT REMOVED ANY TIME PRIOR TO THE ARCING EVENT. UPON REMOVAL, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED. THE SURGEON CONFIRMED THAT THERE WAS NO PATIENT HARM, INJURY OR ADVERSE OUTCOME DUE TO THE REPORTED ARCING INCIDENT. THE SURGEON MENTIONED THAT THE PATIENT HAD CODED, REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), HOWEVER, HE CLARIFIED THAT THIS WAS DUE TO ANESTHESIA AND NOT RELATED TO THE DA VINCI SYSTEM OR ISI PRODUCTS." } ], "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": "" } ] }