{ "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": "2955842-2025-44013", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251112", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20251002", "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", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20251112", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20140916", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1083306", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251112", "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": "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251215", "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": "20251112", "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": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20251112", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23531646", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251015", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "384875082", "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 FELL INTO PATIENT INTRA-ABDOMINALLY ON (B)(6) 2025. LAPAROSCOPY AND EXPLORATION LAPAROTOMY DID NOT FIND THE FOREIGN BODY. THE COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THE NEXT DAY CONFIRMED AN INTRA-ABDOMINAL FOREIGN BODY. REPEAT SURGERY WAS SCHEDULED FOR (B)(6) 2025 FOR REMOVAL OF THE FOREIGN BODY BUT WAS PERFORMED ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS CHECKED BY THE NURSE PRIOR TO USE, BUT NOT BY THE SURGEON. DURING INSTRUMENT REMOVAL, THE NURSE OBSERVED THE MCS TIP COVER ACCESSORY SLIPPING. IT WAS REMOVED AND INSPECTED FOR PROPER PLACEMENT, THEN REATTACHED. HOWEVER, ONCE INSIDE THE ABDOMEN, THE COVER BEGAN TO SLIP AGAIN, DEVELOPED A VISIBLE CRACK, AND ULTIMATELY FELL INTO THE ABDOMEN DURING WITHDRAWAL. THE SURGEON SUSPECTS THE CAUSE WAS ¿SNAGGING¿ OF THE PROTECTIVE SHEATH AT THE INTERNAL ORIFICE OF THE TROCAR. THE EXACT DURATION OF MCS USE WAS DIFFICULT TO ESTIMATE, BUT THREE TIP COVERS WERE REQUIRED, AS TWO CRACKED¿ONLY ONE OF WHICH FELL INTO THE ABDOMEN, AND THE SECOND WAS REPLACED DUE TO SIMILAR DEFECTS AND TO AVOID SLIPPING. NO FUNCTIONALITY ISSUES WITH THE MCS INSTRUMENT WERE NOTED DURING THE PROCEDURE, AND NO INSTRUMENT COLLISIONS OCCURRED. THE TIP COVER HAD BEEN INSTALLED CORRECTLY USING THE REQUIRED TOOL, WITHOUT ANY LUBRICANT, AND NO REDUCER WAS USED. THE ORANGE SURFACE BECAME VISIBLE AS THE COVER SLIPPED AND BECAME FRAGILE, PROMPTING REMOVAL. THERE WAS NO DIFFICULTY REMOVING THE INSTRUMENT EXCEPT FOR THE LOSS OF THE ACCESSORY. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL, AND AFTER THE EVENT, THE STAFF FOUND THE TIP COVER CRACKED BUT OBSERVED NO ADDITIONAL DAMAGE TO THE INSTRUMENT OR CANNULA. THE MCS TIP COVER ACCESSORY IS AVAILABLE FOR RETURN TO ISI FOR EVALUATION, BUT THERE ARE NO PHOTOGRAPHS OR VIDEOS AVAILABLE FOR REVIEW." }, { "mdr_text_key": "384875083", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP COVER HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." } ], "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": "" } ] }