{ "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": "2955842-2020-10839", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200831", "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": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL", "O" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200831", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "938962", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200831", "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": "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": "M90200330", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)M90200330", "openfda": { "registration_number": [ "2955842" ], "fei_number": [ "3008615487" ], "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20200831", "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": "20200806", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10475170", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200806", "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": "205139563", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT RECEIVED THE MCS TIP COVER ACCESSORY FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A LOG REVIEW WAS NOT CONDUCTED AS NO LOGS ARE AVAILABLE FOR THE MCS TIP COVER ACCESSORY. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT AN MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING/MISUSE. THE MCS TIP COVER ACCESSORY WAS NOT RETRIEVED. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE ISSUE TO OCCUR. AS OF THE DATE OF THIS REPORT, THERE WERE NO POST-OPERATIVE COMPLICATIONS REPORTED IN RELATION TO THE PATIENT RETAINING A FOREIGN OBJECT." }, { "mdr_text_key": "205139564", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE ON AN UNKNOWN DATE, THE TIP COVER ACCESSORY OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FELL INTO THE PATIENT'S ANATOMY AND WAS NOT RETRIEVED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 10-AUG-2020 AND 19-AUG-2020 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT DATE IS UNKNOWN. THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY WAS INSTALLED PROPERLY WITH THE INSTALLATION TOOL. THERE WAS NO RESISTANCE FELT UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE MCS INSTRUMENT AND NO INSTRUMENT COLLISIONS. THE MCS INSTRUMENT WAS IN USE DURING THE WHOLE PROCEDURE. THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT AT THE END OF THE PROCEDURE AND IT COULD NOT BE FOUND OR RETRIEVED. THERE WERE NO POST-OPERATIVE COMPLICATIONS. IT WAS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE. THE PATIENT¿S STATUS WAS \"NORMAL.\" THE PROCEDURE WAS NOT RECORDED ON VIDEO." } ], "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": "" } ] }