{ "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": "2955842-2021-10244", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210312", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210210", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "", "date_added": "20210312", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "370435", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210312", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-14", "catalog_number": "400180", "lot_number": "M90200629", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210331", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)M90200908", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Separation", "Material Separation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/15/2021;05/07/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20210312", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210215", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11478239", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210215", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "245737453", "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. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. 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: AFTER THE COMPLETION OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON REPORTEDLY NOTICED THAT THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED ON THE MCS INSTRUMENT AND HAD FALLEN INSIDE THE PATIENT. ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE MCS TIP COVER ACCESSORY AND IT WAS CONFIRMED THAT THE MCS TIP COVER ACCESSORY WAS SUCCESSFULLY RETRIEVED WITH NO INJURY OCCURRING TO THE PATIENT. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER ACCESSORY TO FALL OFF OF THE INSTRUMENT." }, { "mdr_text_key": "245737454", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER THE COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON NOTICED THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS NOT INSTALLED ON THE MCS INSTRUMENT. THE CUSTOMER STATED THAT THE SURGEON SEARCHED FOR THE MCS TIP COVER ACCESSORY BUT COULD NOT LOCATE IT. THE CUSTOMER ALSO STATED THAT THE SURGEON INSERTED A PORT INTO THE PATIENT, CHECKED INSIDE OF THE PATIENT'S ABDOMINAL CAVITY, AND FOUND THAT THE MCS TIP COVER ACCESSORY HAD FALLEN INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE NOTED WITH IT. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE DURING THE SURGICAL PROCEDURE. ALL PORTS HAD BEEN REMOVED FROM THE PATIENT AND THE SURGEON HAD ALREADY CLOSED THE PATIENT'S ABDOMEN AT THE TIME OF IDENTIFYING THE ISSUE. A PORT WAS RE-INSERTED INTO THE PATIENT TO RETRIEVE THE MCS TIP COVER ACCESSORY AND THE ITEM WAS RETRIEVED SUCCESSFULLY WITH NO INJURY OCCURRING TO THE PATIENT." }, { "mdr_text_key": "324673061", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FOLLOW UP ACTIVITY CONDUCTED ON 07-MAY-2021 OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: A CANNULA REDUCER WAS NOT USED WITH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. NO RESISTANCE WAS OBSERVED DURING MCS INSTRUMENT REMOVAL." }, { "mdr_text_key": "324673062", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "324249106", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "324249107", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTED INFORMATION CAN BE FOUND IN FIELD D4. ADDITIONAL INFORMATION CAN BE FOUND IN FIELDS D9, G3, G6, H2, H3, H6, AND H10/H11. D02 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS FOUND TO HAVE TEARING AT THE MOUTH AT THE CLEAR SILICONE TIP, BUT THERE WERE NO MISSING PIECES. THE TEARS MEASURED FROM 0.207\" IN LENGTH AND THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. TEARS AT THE MOUTH ARE MOST COMMONLY CAUSED BY REPEATED THERMAL AND MECHANICAL STRESS." } ], "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": "04/12/2021;06/03/2021" } ] }