{ "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": "2955842-2020-10487", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200513", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20200415", "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": [ "Foreign", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "PL", "manufacturer_contact_area_code": "408", "date_added": "20200513", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20140916", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "518194", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200513", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "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": "400180-14", "catalog_number": "400180", "lot_number": "N/A", "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": "", "udi_public": "", "openfda": { "registration_number": [ "2955842" ], "fei_number": [ "3008615487" ], "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/18/2020;04/16/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250731", "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": "20200513", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20200416", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10054531", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200416", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "319400847", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "319400848", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ASSOCIATED WITH THIS COMPLAINT WAS RETURNED FOR FAILURE ANALYSIS BUT THE REPORTED FAILURE (I.E. ARCING ISSUES USING CURVED SCISSORS AND FENESTRATED BIPOLAR FORCEPS) COULD NOT BE REPRODUCED. THE UNIT WAS TESTED USING THE SAME INSTRUMENT TYPES BUT THE FAILURE WAS NOT REPLICATED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM UNDER NORMAL MODE. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS." }, { "mdr_text_key": "329803518", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "329803519", "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 DUE TO THE REPORT THAT AN ARCING EVENT ALLEGEDLY OCCURRED WHILE THE SURGEON WAS USING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH A MCS TIP COVER ACCESSORY INSTALLED. THE ARCING EVENT OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO COAGULATE A PULSATING ARTERY THAT WAS UNDER A VEIN. AS A RESULT OF THE ALLEGED ARCING ISSUE, ENERGY BURNED THE VEIN. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELDS: B1, B2, ANNEX E, ANNEX F, ANNEX A, ANNEX G, ANNEX B, AND ANNEX D. B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO REFLECT OUTCOME ANNEX E UPDATED TO INCLUDE E1704 DUE TO THE REPORT OF BURNED VEIN. ANNEX F UPDATED TO INCLUDE F24 DUE TO INSUFFICIENT INFORMATION. ANNEX A UPDATED TO INCLUDE A0703 DUE TO REPORT OF ARCHING EVENT. ANNEX G UPDATED TO INCLUDE G04075 DUE TO COMPONENT ATTRIBUTED TO FAILURE MODE. ANNEX B UPDATED TO INCLUDE B13 DUE TO ATTEMPTS TO COMMUNICATE FOR ADDITIONAL INFORMATION. ANNEX B UPDATED TO INCLUDE B17 DUE TO NO INSTRUMENT RETURNED FOR EVALUATION. ANNEX C UPDATED TO INCLUDE C20 DUE TO ADDITIONAL INFORMATION NOT BEING RECEIVED. ANNEX D UPDATED TO INCLUDE D15 DUE TO ADDITIONAL INFORMATION NOT BEING RECEIVED." }, { "mdr_text_key": "240354741", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE MCS TIP COVER ACCESSORY INVOLVED WITH THE REPORTED EVENT WAS INSPECTED BEFORE AND AFTER THE EVENT OCCURRED, AND NO ISSUES WERE IDENTIFIED. THE MCS TIP COVER ACCESSORY WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR ISI TO EVALUATE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020. THE SURGEON PERFORMED 2 DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES THAT DAY; HOWEVER, IT IS UNCLEAR WHICH CASE IS ASSOCIATED WITH THE REPORTED EVENT. PER THE SYSTEM LOGS, A MCS INSTRUMENT WAS USED DURING CASE. IN ADDITION, BOTH MCS INSTRUMENTS HAVE BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES. THE PROCEDURE WAS NOT RECORDED AND THERE WAS NO IMAGE PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT ELECTRICAL ENERGY ARCED FROM A MCS INSTRUMENT WITH AN MCS TIP COVER ACCESSORY INSTALLED. AT THIS TIME, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN. ALSO, ALTHOUGH THE PATIENT SUSTAINED A BURN INJURY TO A VESSEL, THERE IS NO INDICATION THAT A SERIOUS INJURY OCCURRED. THERE IS NO EVIDENCE THAT THE BURN INJURY REQUIRED MEDICAL INTERVENTION, WAS LIFE-THREATENING, OR RESULTED WITH PERMANENT IMPAIRMENT." }, { "mdr_text_key": "240354742", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE WITH LYMPHADENECTOMY PROCEDURE, AN ARCING EVENT ALLEGEDLY OCCURRED WHILE THE SURGEON WAS USING A MONOPOLAR CURVED SCISSORS NSTRUMENT WITH A MCS TIP COVER ACCESSORY INSTALLED. ACCORDING TO THE INITIAL REPORTER, THE ARCING EVENT OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO COAGULATE A PULSATING ARTERY THAT WAS UNDER A VEIN. AS A RESULT OF THE ALLEGED ARCING ISSUE, THE INITIAL REPORTER CLAIMED THAT ENERGY BURNED THE VEIN. THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. IT WAS NOTED THAT WHEN THE ARCING EVENT OCCURRED, THE SURGEON WAS ACTIVATING MONOPOLAR COAG ENERGY WITH THE MCS INSTRUMENT. HOWEVER, IT WAS ALSO NOTED THAT THE MCS INSTRUMENT WAS NOT BURNED AS A RESULT OF THE ALLEGED ARCING ISSUE. THE MCS INSTRUMENT IS NOT AVAILABLE FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A LARGE NEEDLE DRIVER INSTRUMENT AND A FENESTRATED BIPOLAR FORCEPS INSTRUMENT WERE ALSO IN USE DURING THE PROCEDURE. THERE WERE NO REPORTED INSTRUMENT COLLISIONS DURING THE CASE. ON 12-MAY-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO ISSUES WERE IDENTIFIED AT THE TIME. THE MCS TIP COVER ACCESSORY WAS INSTALLED PROPERLY. AT THE TIME THE ARCING EVENT OCCURRED, THE SHAFT OF THE MCS INSTRUMENT WAS TOUCHING THE VEIN. THE FIRST ASSISTANT DURING THE CASE REPORTEDLY WITNESSED THE ARCING. THE SEVERITY OF THE BURN INJURY TO THE VEIN WAS 1ST DEGREE. NO REPAIR OR MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE BURN INJURY. AFTER THE EVENT OCCURRED, THE MCS TIP COVER ACCESSORY WAS INSPECTED AND NO SIGNS OF DAMAGE WERE FOUND. THE MCS TIP COVER ACCESSORY WAS DISCARDED BY THE SITE AFTER THE PROCEDURE WAS COMPLETED." } ], "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": "07/16/2020;06/10/2022" } ] }