{ "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": "2955842-2020-10622", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200701", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20200316", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "OTHER", "USE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200701", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "682895", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200701", "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": "400180-12", "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": "", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/19/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20200701", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "39 YR", "patient_sex": "", "patient_weight": "61", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20200603", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10221537", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200603", "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": "315210943", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS G4, G7, H2, AND H10. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT OF AN ARCING EVENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT TIP OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS TESTED FOR ENERGY DELIVERY ON AN IN-HOUSE SYSTEM. ENERGY WAS DELIVERED WITHOUT ANY ISSUES AND THE ELECTRICAL CONTINUITY TEST PASSED. NO ARCING WAS OBSERVED. ADDITIONAL FINDINGS NOT REPORTED BY SITE WAS THAT THE PROXIMAL CLEVIS WAS FOUND TO HAVE SCRATCH MARKS. THE SCRATCH MARKS MEASURED ROUGHLY 0.355\" IN LENGTH. THE INSTRUMENT TUBE EXTENSION ALSO EXHIBITED SIGNS OF SCRATCH MARKS ON THE DISTAL END. THE TUBE EXTENSION SCRATCH MARKS MEASURED ROUGHLY 0.073¿ X 0.340¿. THIS FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE, SUCH AS EXCESSIVE CONTACT WITH ABRASIVE OR HARD SURFACES DURING TRANSPORT OR REPROCESSING, OR DURING TIP COVER INSTALLATION/REMOVAL. THE MCS TIP COVER ACCESSORY USED DURING THE REPORTED EVENT HAS NOT BEEN RETURNED TO ISI FOR ANALYSIS. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A MCS INSTRUMENT ALLEGEDLY CAUSED A HOLE IN THE PATIENT¿S COLON. IN ADDITION, A HOLE WAS IDENTIFIED ON THE MCS TIP COVER ACCESSORY INSTALLED ON THE MCS INSTRUMENT. AS A RESULT OF THE INTRA-OPERATIVE COMPLICATION, A COLON RESECTION WAS PERFORMED. HOWEVER, AT THIS TIME, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND BOWEL INJURY IS STILL UNKNOWN." }, { "mdr_text_key": "315210944", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "203132105", "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 IS UNKNOWN. ISI HAS REQUESTED FOR THE MCS TIP COVER ACCESSORY AND MCS INSTRUMENT TO BE RETURNED FOR EVALUATION. ISI HAS ALSO ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, ISI HAS NOT RECEIVED THE MCS INSTRUMENT OR MCS TIP COVER ACCESSORY, AND NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE UF/IMPORTER REPORT PROVIDED BY THE SITE¿S RISK MANAGEMENT DEPARTMENT HAD THE MCS INSTRUMENT LISTED WITH LOT #N10191112-0040. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. PER THE INSTRUMENT LOGS, THIS PARTICULAR MCS INSTRUMENT WAS INSTALLED ON A DA VINCI SYSTEM TWO ADDITIONAL TIMES BUT NOT USED IN AN ACTUAL SURGICAL PROCEDURE. SITE REVIEWS HAVE SHOWN NO ADDITIONAL OR RELATED COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES, WITH THE EXCEPTION OF THE FOLLOWING: MONOPOLAR CURVED SCISSORS (PART #470179-19; LOT #N10191112-0037) AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. VESSEL SEALER EXTEND (PART #480422-01; LOT #M90191210-0202) WHICH IS A SINGLE USE INSTRUMENT AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. PER THE INSTRUMENTS & ACCESSORIES USER MANUAL: \"THE ENDOWRIST MONOPOLAR CURVED SCISSORS INSTRUMENT IS A MULTIPLE-USE ENDOSCOPIC INSTRUMENT UTILIZING A SINGLE-USE TIP COVER ACCESSORY, TO BE USED IN CONJUNCTION WITH THE INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM.\" THE INTENDED USE OF THE MCS TIP COVER ACCESSORY IS AS FOLLOWS: \"THE TIP COVER ACCESSORY IS INTENDED TO PROVIDE INSULATION OVER A SECTION OF THE ENDOWRIST MONOPOLAR CURVED SCISSORS INSTRUMENT SO THAT RF ENERGY IS ONLY AVAILABLE AT THE TIP.\" ADDITIONALLY, THE INSTRUMENTS & ACCESSORIES USER MANUAL PROVIDED THE FOLLOWING GENERAL PRECAUTIONS AND WARNINGS: \"EXERCISE CAUTION WHEN WORKING WITH MONOPOLAR INSTRUMENTS CLOSE TO OTHER INSTRUMENTS. UNINTENDED ENERGY MAY BE DELIVERED FROM THE ACTIVE MONOPOLAR INSTRUMENT TO A SECOND INSTRUMENT. THIS COULD RESULT IN BURNS TO TISSUE IN CONTACT WITH ANY OF THE SECOND INSTRUMENT¿S METAL PARTS OR ITS CANNULA. TO EXERCISE CAUTION IN THESE SCENARIOS, THE MONOPOLAR TIP SHOULD BE CLOSER TO THE TISSUE THAN TO THE SECOND INSTRUMENT. WARNING: FAILURE TO FOLLOW THESE PRECAUTIONS WILL RESULT IN ELECTRICAL ARCS FROM THE WRIST AND ALTERNATE SITE BURNS. WARNING: AS WITH ANY ELECTROSURGICAL DEVICE, IT IS POSSIBLE FOR ENERGY TO DISCHARGE IN AN AREA OTHER THAN THE INSTRUMENT TIP. IT IS IMPORTANT TO EXERCISE CAUTION WHEN USING AN ENERGIZED ENDOWRIST MONOPOLAR CURVED SCISSORS INSTRUMENT TO HELP AVOID UNINTENDED CONTACT WITH TISSUE ADJACENT TO THE AREA TO BE CAUTERIZED.\" WARNING: DO NOT USE THIS INSTRUMENT TO ENERGIZE THE TIPS OF OTHER INSTRUMENTS. THIS MAY DAMAGE THE END EFFECTORS OR INJURE TISSUE INSIDE OR OUTSIDE THE FIELD OF VIEW. TISSUE DAMAGE COULD OCCUR AT POINTS NEAR THE TIP OR AT THE PORT SITE (CANNULA) OF THE ENERGIZED INSTRUMENT.\" THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A MCS INSTRUMENT ALLEGEDLY CAUSED A HOLE IN THE PATIENT¿S COLON. IN ADDITION, A HOLE WAS IDENTIFIED ON THE MCS TIP COVER ACCESSORY INSTALLED ON THE MCS INSTRUMENT. AS A RESULT OF THE INTRA-OPERATIVE COMPLICATION, A COLON RESECTION WAS PERFORMED. HOWEVER, AT THIS TIME, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND BOWEL INJURY IS UNKNOWN." }, { "mdr_text_key": "203132106", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 04-JUN-2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA UF/IMPORTER REPORT #(B)(4) (PATIENT IDENTIFIER (B)(6)) WITH THE FOLLOWING EVENT DESCRIPTION: ¿PATIENT TO OR ON (B)(6) 2020 FOR INTENDED PROCEDURE OF ROBOTIC XI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL URETEROLYSIS, PELVIC AND PARA-AORTIC LYMPH NODE DISSECTION, OMENTECTOMY. WHILE MD WAS USING ROBOTIC XI SCISSORS, THE INSTRUMENT BURNED A HOLE IN THE PATIENT¿S COLON DURING HYSTERECTOMY. THE TIP COVER ACCESSORY OF THE SCISSORS HAD A HOLE IN SAME. THIS REQUIRED PATIENT TO HAVE A COLON RESECTION. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2020.\" ON 11-JUN-2020, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS NOT PRESENT DURING THE CASE WHICH HE DOES NOT BELIEVE WAS RECORDED ON VIDEO. HE WAS INFORMED OF THE INCIDENT AFTER THE EVENT OCCURRED BY A SCRUB TECH. HE ALSO REPORTEDLY SPOKE TO THE SITE'S ROBOTICS COORDINATOR AND OR DIRECTOR ABOUT THE EVENT. ACCORDING TO THE CSR, THE ROBOTICS COORDINATOR INFORMED HIM THAT THE SITE HAD PULLED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FROM CIRCULATION AND HAD CALLED ISI TO REPORT THE EVENT. PER THE CSR, THE SITE INDICATED THAT THE MCS TIP COVER ACCESSORY WAS INSTALLED CORRECTLY. THE SCRUB TECH INFORMED THE CSR THAT HE BELIEVES THAT THERE WERE POSSIBLE INSTRUMENT COLLISIONS DURING THE CASE. THE HOLE IN THE COLON WAS IDENTIFIED TOWARDS THE END OF A CASE AND HE CONFIRMED THAT A COLON RESECTION WAS PERFORMED DURING THE SAME PROCEDURE AS A RESULT." } ], "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": "09/12/2020" } ] }