{ "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": "2955842-2021-10798", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210715", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210618", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20210715", "manufacturer_contact_f_name": "DAVID", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1074589", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210715", "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": "UNKNOWN", "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": { "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": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/18/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20210715", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210618", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12178596", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210618", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "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": "265643840", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MCS TIP COVER ACCESSORY FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. 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. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. VERIFICATION OF THE PRODUCT AND EVENT DETAILS VIA SYSTEM LOGS CANNOT BE PERFORMED AT THIS TIME BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED AND ACCESSORY PRODUCTS ARE NOT COVERED IN THE LOGS. A SITE HISTORY COMPLAINT REVIEW WAS PERFORMED AND NO OTHER COMPLAINTS WERE REPORTED FOR THIS PRODUCT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE THE MCS TIP COVER ACCESSORY FELL OFF OF THE INSTRUMENT AND INTO THE PATIENT'S ANATOMY. THE ITEM WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED ITEMS FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. RECURRENCE OF THE FAILURE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER ACCESSORY TO FALL INSIDE THE PATIENT. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT'S LOT NUMBER WAS NOT AVAILABLE SO THE LOT NUMBER AND THE UDI ARE UNKNOWN. THE PRODUCT IS NOT IMPLANTABLE. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE." }, { "mdr_text_key": "265643841", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF THE MCS INSTRUMENT. IT WAS NOTED THAT THEY \"FLIPPED BETWEEN ROBOT TO OPEN TO LAP SEVERAL TIMES\" FOR THE PROCEDURE AND THAT DURING ONE OF THE TRANSITIONS THEY NOTICED THAT THE MCS TIP COVER ACCESSORY WAS MISSING. THE CUSTOMER WAS ASKING IF THE ITEM WAS DETECTABLE VIA X-RAY OR CT SCAN. THE CUSTOMER LATER FOLLOWED UP TO LET US KNOW THAT THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE, AND THAT THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP ON 21-JUNE-2021. THE CUSTOMER WAS UNABLE TO SPECIFY AT WHAT POINT THE MCS TIP COVER ACCESSORY HAD FALLEN OFF OF THE INSTRUMENT. NO FURTHER DETAILS WERE AVAILABLE." }, { "mdr_text_key": "336866656", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336866657", "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. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1: B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO \"REQUIRED INTERVENTION\". H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/24/2023" } ] }