{ "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": "2955842-2020-11289", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201202", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20201106", "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": [ "Other", "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": "20201202", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200220", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1401695", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201202", "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": "M90200224", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201229", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)M90200224", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/30/2020;11/06/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250819", "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": "20201202", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20201106", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10933922", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201106", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "321984433", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "67/4315 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION DID NOT CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE MCS TIP COVER ACCESSORY WAS INSTALLED ON AN IN-HOUSE MCS INSTRUMENT AND COVERED THE ENTIRE DISTAL PORTION OF THE TUBE EXTENSION. THE INSTRUMENT WAS PLACED AND DRIVEN ON THE IN-HOUSE SYSTEM AND REMOVED ALONG WITH THE MCS TIP COVER ACCESSORY WITHOUT ANY ISSUES. THE MCS TIP COVER ACCESSORY DID NOT FALL OFF OR APPEAR TO BE LOOSE DURING TESTING. UPON VISUAL INSPECTION, NO DAMAGE WAS FOUND. NO TEARS WERE OBSERVED AND NO THERMAL DAMAGE WAS IDENTIFIED. NO PROBLEM WAS DETECTED WITH THE MCS TIP COVER ACCESSORY." }, { "mdr_text_key": "335839823", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335839824", "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." }, { "mdr_text_key": "241079296", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT RECEIVED THE MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT. IF THE PRODUCT IS RECEIVED OR IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE) AND IT WAS DIFFICULT TO TELL WHETHER THERE WAS ANY DAMAGE DUE TO THE TIP COVER BEING WRAPPED IN SOME SORT OF PLASTIC IN THE IMAGE. LOOKING AT THE IMAGE, IT DID NOT SEEM LIKE THERE WAS ANY OBVIOUS DAMAGE TO THE DARK GRAY PORTION OF THE TIP COVER. THE GLARE OF THE PLASTIC THAT IS WRAPPING THE TIP COVER MADE IT DIFFICULT TO ASSESS WHETHER THERE WAS ANY DAMAGE ON THE LIGHTER PORTION AT THE TOP OF THE COVER. THE MCS TIP COVER ACCESSORY, WHEN USED AS INTENDED, PROVIDES INSULATION OVER A SECTION OF THE ENDOWRIST MONOPOLAR CURVED SCISSORS INSTRUMENT SO THAT RADIO FREQUENCY (RF) ENERGY IS ONLY AVAILABLE AT THE INSTRUMENT SCISSOR TIPS. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE: DURING A DA VINCI SURGICAL PROCEDURE, THE MCS TIP COVER ACCESSORY REPORTEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED. ALTHOUGH THERE WAS NO REPORT OF PATIENT INJURY, UNINTENDED ITEMS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER TO COME OFF OF THE INSTRUMENT." }, { "mdr_text_key": "241079297", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY SURGICAL PROCEDURE, WHEN THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS PULLED OUT, THE MCS TIP COVER ACCESSORY CAME OFF OF THE INSTRUMENT AND REMAINED IN THE TROCAR EVEN THOUGH IT DID NOT HIT ANYTHING IN PARTICULAR. IT WAS REPORTED THAT WHEN THE CUSTOMER TRIED TO TAKE OUT THE MCS TIP COVER ACCESSORY, IT WENT UNDER THE SKIN OF THE PATIENT. THE CUSTOMER STATED THAT THE MCS TIP COVER ACCESSORY WAS SUCCESSFULLY REMOVED AND A NEW MCS TIP COVER ACCESSORY WAS USED TO COMPLETE THE PROCEDURE. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), WHO WAS PRESENT AT THE PROCEDURE, CONFIRMED THAT NO INSTRUMENT COLLISION OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE EVENT: THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE FOUND. THE MCS TIP COVER ACCESSORY WAS RETRIEVED BY ENLARGING THE ORIGINAL PORT SITE INCISION FROM THE BODY CAVITY SIDE. NO FUNCTIONAL ISSUES WERE EXPERIENCED WITH THE MCS INSTRUMENT DURING PROCEDURE. THE ISSUE OCCURRED SUDDENLY WHEN REMOVING THE INSTRUMENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA AND THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE ON THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. THE MCS TIP COVER ACCESSORY WAS IN USE ABOUT 2 HOURS AND 20 MINUTES BEFORE THE MALFUNCTION OCCURRED, THE STAFF REMOVED THE TIP COVER FOR CLEANING, AND THERE WAS NOTHING WRONG WITH IT. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE AND THE ORANGE SURFACE WAS NOT VISIBLE AFTER INSTALLATION. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE AND IT IS UNKNOWN WHETHER THE INSTALLATION TOOL WAS USED. THE CUSTOMER CONFIRMED THE THEY USUALLY USE THE INSTALLATION TOOL. THE CUSTOMER DID NOT APPLY ELECTROLUBE OR ANY OTHER LUBRICANT TO THE MCS INSTRUMENT PRIOR TO THE MCS TIP COVER ACCESSORY INSTALLATION. THE MCS INSTRUMENT WILL NOT BE RETURNED TO ISI FOR EVALUATION AS THERE WAS NO SUSPECTED MALFUNCTION OF THE MCS INSTRUMENT. NO INJURY OCCURRED TO THE PATIENT." } ], "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": "01/29/2021;05/24/2023" } ] }