{ "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": "2955842-2021-10597", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210601", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20210601", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20140916", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "811572", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210601", "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": "NA", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/06/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250821", "health_professional": "Y", "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": "20210601", "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": "20210506", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11911239", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210506", "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": "336761406", "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": "336761407", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "254829190", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WILL NOT BE RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. THE CUSTOMER ALSO STATED THAT THE MCS INSTRUMENT IS NOT AVAILABLE FOR ISI EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCTS RELATED TO THE COMPLAINT CANNOT BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS FOR THIS PRODUCT OR EVENT. VERIFICATION OF THE ACCESSORY PRODUCT VIA SYSTEM LOGS CANNOT BE PERFORMED BECAUSE ACCESSORY DEVICE PRODUCT DETAILS ARE NOT CAPTURED IN THE SYSTEM LOG. A SYSTEM LOG REVIEW COULD NOT BE PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. NO IMAGE OR PROCEDURE VIDEO OF THE EVENT WAS PROVIDED FOR REVIEW. 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. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING/MISUSE. THE MCS TIP COVER ACCESSORY WAS RETRIEVED 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 ITEM TO FALL INSIDE THE PATIENT. ALTHOUGH THERE WAS NO PATIENT INJURY REPORTED, IF THIS EVENT WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "254829191", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OF THE MCS INSTRUMENT AND FELL INTO THE PATIENT. THE MCS TIP COVER ACCESSORY WAS REMOVED AND WAS DISCARDED. THE PROCEDURE WAS COMPLETED USING A BACKUP MCS TIP COVER ACCESSORY WITH NO REPORTED INJURY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) PROVIDED THE FOLLOWING INFORMATION: THE OR NURSE WHO REPORTED THIS ISSUE TO THE CTA STATED SHE DOES NOT HAVE THE EVENT DATE INFORMATION. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. INSTALLATION OF THE TIP COVER ACCESSORY ONTO THE MCS INSTRUMENT WAS \"EASIER THAN NORMAL.\" THE MCS TIP COVER ACCESSORY FELL INTO THE ABDOMEN AND THEY RETRIEVED IT WITH THE REMAINING INSTRUMENTS. INSTRUMENT REMOVAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE NURSE TOLD THE CTA THAT THE MCS TIP COVER ACCESSORY AND THE MCS HAVE NOT BEEN DAMAGED. THE ORANGE SURFACE OF THE MCS INSTRUMENT WAS NOT VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. NO ELECTROLUBE OR OTHER LUBRICANT WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO THE MCS TIP COVER ACCESSORY INSTALLATION. THERE WAS A 5 MINUTE DELAY IN PROCEDURE, SINCE THEY HAD TO SEARCH THE MCS TIP COVER ACCESSORY IN THE ABDOMEN, REMOVE IT, AND INSTALL THE NEW MCS TIP COVER ACCESSORY ON THE MCS INSTRUMENT. NEITHER THE MCS INSTRUMENT NOR THE MCS TIP COVER ACCESSORY ARE AVAILABLE FOR ISI EVALUATION." } ], "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" } ] }