{ "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": "2955842-2025-23802", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250609", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250520", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250609", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "983716", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250609", "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", "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": "N", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250826", "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": "20250609", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250522", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22171808", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250522", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "372036975", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE SURGEON DIDN'T REALIZE IT FELL UNTIL THEY FINISHED THE CASE AND WERE DOING THE COUNTING. THE PATIENT WAS STILL ON THE TABLE, SO A CT SCAN WAS DONE TO LOCATE THE MCS TIP COVER. THE CUSTOMER WAS ABLE TO RETRIEVE IT, HOWEVER, THEY SAID IT TOOK THEM A LONG TIME WHICH CAUSED A DELAY TO THE CASE. NOT SURE THE EXACT DELAY TIME BUT IT WAS LONG. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SURGEON OPENED THE PATIENT AND FOUND THE MISSING MCS TIP COVER ACCESSORY. SURGERY WAS COMPLETED WHEN THE MCS TIP COVER WAS FOUND. THE SCRUB TECHNICIAN NOTICED A MISSING TIP COVER AT THE END OF THE CASE ONCE THE COUNT NUMBER WAS OFF ON THE MATERIALS USED IN THE CASE. IT IS UNKNOWN WHAT THE SURGEON BELIEVES WAS THE CAUSE OF THE INSTRUMENT ACCESSORY SLIP-OFF. THE MCS TIP COVERS ARE IN USE FOR 30 MINUTES. NO ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT WERE NOTED DURING THE CASE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED DURING THE PROCEDURE. NO ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. IT WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. ELECTROLUBE WAS USED TO APPLY THE MCS TIP COVER ON THE INSTRUMENT. THE REDUCER WAS NOT USED. THE MCS TIP COVER SLIPPED FROM THE INSTRUMENT WITHOUT FORCE WHILE REMOVING THE INSTRUMENT; THE INSTRUMENT WRIST WAS STRAIGHTENED UPON FINAL REMOVAL. NO DAMAGE WAS NOTED TO THE MCS TIP COVER ACCESSORY, INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. THE PROCEDURE WAS CONVERTED TO LAB AND THEN CONVERTED TO OPEN. THE MCS TIP COVER ACCESSORY AND THE INSTRUMENT ARE NOT AVAILABLE FOR RETURN. IT IS UNKNOWN IF PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS ARE AVAILABLE FOR ISI REVIEW; THE CRS WILL ASK." }, { "mdr_text_key": "372036976", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER DID NOT CALL CUSTOMER SERVICE TO CREATE RMA FOR REPORTED ACCESSORY. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }