{ "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": "2955842-2020-11334", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20201211", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20200819", "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": [ "OTHER", "USER FACILITY" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20201211", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1457172", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201211", "brand_name": "DA VINCI ACCESSORY", "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": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "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": "20201211", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20201112", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10989404", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201112", "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": "220913386", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY HAS NOT BEEN RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE ACCESSORY IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY CANNOT BE CONDUCTED AT THIS TIME AS THE SITE NAME, SURGEON NAME, AND DAVINCI SYSTEM INFORMATION WERE NOT PROVIDED AND REMAIN UNAVAILABLE. A REVIEW OF THE SYSTEM AND INSTRUMENT LOG FOR THE REPORTED PROCEDURE DATE CANNOT BE CONDUCTED AT THIS TIME AS THE DA VINCI SYSTEM INFORMATION WAS NOT PROVIDED AND REMAINS UNAVAILABLE. ADDITIONALLY, THE PRODUCT ASSOCIATED WITH THIS COMPLAINT IS AN ACCESSORY AND DOES NOT GET CAPTURED IN THE LOGS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE MCS TIP COVER ACCESSORY WAS COMING OFF THE MCS INSTRUMENT. ALTHOUGH NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED, IT IS UNKNOWN WHAT CAUSED THE ACCESSORY TO COME OFF THE MCS INSTRUMENT INSIDE THE PATIENT AND IT IS UNKNOWN IF THE MCS TIP COVER FELL INSIDE OF THE PATIENT OR WAS RETRIEVED DURING THE SAME PROCEDURE. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE." }, { "mdr_text_key": "220913387", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 12-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW 5096343 STATING: \"SCISSOR TIP SHEATH ON INTUITIVE SCISSORS COMES OFF DURING SURGICAL PROCEDURE. FDA SAFETY REPORT ID#: (B)(4).\" ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." } ], "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": "" } ] }