{ "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": "2955842-2020-10145", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200226", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200226", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "217436", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200226", "brand_name": "DA VINCI S", "generic_name": "BLADELESS OBTURATOR", "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": "420023-03", "catalog_number": "", "lot_number": "73H1800102", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200221", "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": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20200226", "sequence_number_treatment": [ "" ], "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": "20200131", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9754634", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200131", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "189469823", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 8MM BLADELESS OBTURATOR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF \"TIP BROKE OFF AND FELL INSIDE THE PATIENT\". THE TIP OF THE OBTURATOR SHAFT WAS FOUND TO BE BROKEN. APPROXIMATELY .177\" WAS BROKEN OFF AND WAS NOT RETURNED. THIS FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE 8MM BLADELESS OBTURATOR \"BROKE OFF AND FELL INSIDE THE PATIENT\". THE FRAGMENT WAS NOT FOUND OR RETRIEVED. AT THIS TIME, THE LOCATION OF THE MISSING INSTRUMENT FRAGMENT IS UNKNOWN." }, { "mdr_text_key": "189469824", "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 8MM BLADELESS OBTURATOR INSTRUMENT TIP WAS BROKEN OFF AND FELL INSIDE THE PATIENT. THE TIP WAS NOT RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO OTHER REPORTED ISSUES. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM (OR) MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP OF THE 8MM BLADELESS OBTURATOR INSTRUMENT WAS NOT RETRIEVED. THE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE OR MANAGER WAS NOT SURE IF THE INSTRUMENT WAS INSPECTED PRIOR TO USE OR IF THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE. THE OR MANAGER WAS UNSURE IF ANY POST-OPERATIVE TESTS (X-RAY, ULTRA SOUND) WERE PERFORMED TO CHECK FOR THE TIP. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE OPERATION ROOM MANAGER NOTED THAT THE INSTRUMENT WOULD BE RETURNED TO ISI FOR FAILURE INVESTIGATION." } ], "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": "" } ] }