{ "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": "2955842-2020-10499", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200519", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20200422", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20200519", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200116", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "533082", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200519", "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": "M90200117", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200528", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874111048", "udi_public": "(01)00886874111048(17)220131(10)M90200117", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Detachment of Device or Device Component", "Material Fragmentation", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/29/2020;04/24/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250807", "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": "20200519", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20200424", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10068484", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200424", "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": "329472367", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "329472368", "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 SINCE THE MCS TIP COVER ACCESSORY GOT DETACHED FROM THE MCS INSTRUMENT WHEN REMOVING THE MCS INSTRUMENT. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT'S BODY AND WAS RETRIEVED DURING THE SAME PROCEDURE. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELDS: B1, B2, H1. UPDATED SECTION B1 TO BE ADVERSE EVENT AND PRODUCT PROBLEM. UPDATED SECTION B2 TO BE REQUIRED INTERVENTION. UPDATED SECTION H1 TO ADD SERIOUS INJURY." }, { "mdr_text_key": "318337491", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR ADDITIONAL INFORMATION." }, { "mdr_text_key": "318337492", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D10, G4, G7, H3, H6, H10. 67 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. VISUAL INSPECTION FOUND NO PHYSICAL OR THERMAL DAMAGE. THE MCS TIP COVER ACCESSORY WAS INSERTED ONTO AN IN-HOUSE MCS INSTRUMENT USING AN MCS INSTALLATION TOOL AND THEN FUNCTIONALLY TESTED. THE MCS TIP COVER ACCESSORY HELD ITS PLACE AND DID NOT FALL OFF DURING FUNCTIONAL TESTING. THE MCS INSTRUMENT PASSED ALL TESTING SPECIFICATION WITHOUT ISSUE." }, { "mdr_text_key": "191830863", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. MULTIPLE OCCURRENCES OF INSTRUMENT COLLISION WITH ANOTHER INSTRUMENT OR A HARD OBJECT DURING INTRAOPERATIVE USE, WHETHER INTENTIONAL OR ACCIDENTAL, IS KNOWN TO POSSIBLY CAUSE OR CONTRIBUTE TO MCS TIP COVER ACCESSORY DETACHMENT. THE GENERAL PRECAUTIONS AND WARNINGS IN THE INSTRUMENTS AND ACCESSORIES USER MANUAL INSTRUCTS THE USER TO \"USE INSTRUMENTS WITH CARE. AVOID CONTACT BETWEEN INSTRUMENTS INSIDE THE PATIENT AND DO NOT USE ANY INSTRUMENT TO APPLY FORCE TO ANOTHER INSTRUMENT INSIDE THE PATIENT.\" A REVIEW OF THE COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THE PRODUCT OR THE EVENT. REVIEW OF THE SYSTEM LOGS CONFIRMED THE CUSTOMER REPORTED ISSUE USING DA VINCI SYSTEM SK1435 ON THE REPORTED EVENT DATE. THE MCS INSTRUMENT WAS USED ONCE WITH 4 REMAINING USAGE LIVES AFTER THE REPORTED EVENT DATE. THE MCS TIP COVER ACCESSORY IS A SINGLE-USE ACCESSORY WHICH IS INSTALLED ON THE MCS INSTRUMENT. NO ERRORS WOULD BE GENERATED IN THE LOGS FOR THIS FAILURE MODE. NO IMAGE OR VIDEO WAS PROVIDED BY THE SITE FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE MCS TIP COVER ACCESSORY DETACHED FROM THE MCS INSTRUMENT WHEN REMOVING THE MCS INSTRUMENT OUT OF THE USM ARM. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT'S BODY AND WAS RETRIEVED WITHOUT PATIENT HARM, ADVERSE OUTCOME, OR INJURY. HOWEVER, IF THIS FAILURE WERE TO RECUR, IT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN OR UNAVAILABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE." }, { "mdr_text_key": "191830864", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE USER REMOVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FROM THE UNIVERSAL SIDE MANIPULATOR (USM) ARM; HOWEVER, DURING REMOVAL, THE MCS TIP COVER ACCESSORY FELL FROM THE MCS INSTRUMENT TIP. ANOTHER MCS TIP COVER ACCESSORY WAS INSTALLED ONTO THE SAME MCS INSTRUMENT. NO FURTHER ISSUE WAS OBSERVED. THE USER CONTINUED THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON ON (B)(6) 2020: AN INSPECTION OF ALL THE INSTRUMENTS AND ACCESSORIES PRIOR TO USE WAS PERFORMED AND NO ISSUES WERE FOUND. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED USING AN INSTALLATION TOOL. THE SURGEON STATED THAT THE MCS INSTRUMENT WAS IN USE FOR APPROXIMATELY 3 HOURS AND HE NOTED 2 TO 3 INSTANCES OF INSTRUMENT COLLISION INVOLVING THE MCS INSTRUMENT DURING INTRAOPERATIVE USE. THE FALLEN MCS TIP COVER ACCESSORY WAS RETRIEVED USING A GRASPING FORCEPS THROUGH THE ASSIST PORT." } ], "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": "06/19/2020;06/30/2022" } ] }