{ "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": "2955842-2021-11376", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20211024", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "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": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "TU", "manufacturer_contact_area_code": "408", "date_added": "20211024", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20201112", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1585008", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211024", "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": "M90201112", "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": "10886874111045", "udi_public": "(01)10886874111045(10)M90201112", "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 Split, Cut or Torn", "Material Separation", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/29/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "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": "20211024", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210929", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12686983", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210929", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "336860057", "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\"." }, { "mdr_text_key": "336860058", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "284288723", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION PURPOSES. ROOT CAUSE OF THE REPORTED FAILURE MODE COULD NOT BE DETERMINED FOR THIS ALLEGED ISSUE 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 PROCEDURE VIDEO WAS PROVIDED. VERIFICATION OF THE ACCESSORY PRODUCT VIA SYSTEM LOGS CANNOT BE PERFORMED BECAUSE ACCESSORY DEVICE PRODUCT DETAILS ARE NOT CAPTURED IN THE SYSTEM LOG. THE MCS TIP COVER ACCESSORY, WHEN USED AS INTENDED, PROVIDES INSULATION OVER A SECTION OF THE ENDOWRIST MCS INSTRUMENT SO THAT RADIO FREQUENCY (RF) ENERGY IS ONLY AVAILABLE AT THE INSTRUMENT SCISSOR TIPS. PER THE I&A USER MANUAL \"IT IS IMPORTANT TO EXERCISE CAUTION WHEN USING A ENERGIZED ENDOWRIST MCS INSTRUMENT TO HELP AVOID UNINTENDED CONTACT WITH TISSUE ADJACENT TO THE AREA TO BE CAUTERIZED.\" FAILURE TO FOLLOW THESE PRECAUTIONS WILL RESULT IN ELECTRICAL ARCS FROM THE WRIST AND ALTERNATE SITE BURNS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED ITEMS FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE ISSUE TO OCCUR AND THE MCS TIP COVER ACCESSORY TO FALL FROM THE MCS INSTRUMENT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR." }, { "mdr_text_key": "284288724", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SPLIT AND FELL INTO THE PATIENT. THE MCS TIP COVER ACCESSORY WAS REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. PER SUBSEQUENT FOLLOW-UP ON 05-OCT-2021, THE INITIAL REPORTER CONFIRMED THAT THE MCS TIP COVER ACCESSORY FELL OFF DURING REMOVAL OF THE MCS INSTRUMENT. THE ITEM WAS RETRIEVED WITH THE HELP OF THE INSTRUMENT AND ASSISTANT TOOL. THE REPORTER CLARIFIED THAT WHEN THE INSTRUMENT WAS TAKEN OUT, THE OPERATING ROOM STAFF NOTICED THE TIP (CLEAR SILICONE) WAS MISSING. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE. NOTHING ABNORMAL TOOK PLACE. THE MCS INSTRUMENT WRIST WAS STRAIGHTENED, AND NO RESISTANCE WAS FELT UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THE MCS TIP COVER ACCESSORY WAS DISCARDED SO IT IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS." } ], "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" } ] }