{ "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": "2955842-2023-18448", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230914", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20221130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230914", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2253029", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230914", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-15", "catalog_number": "400180", "lot_number": "L80221013", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": "", "date_changed": "20250729", "health_professional": "Y", "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": "20230914", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "42 YR", "patient_sex": "Female", "patient_weight": "94 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230324", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17744773", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230324", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "323392032", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE FALLEN AND RETAINED MCS TIP COVER ACCESSORY CANNOT BE DETERMINED. THE PRODUCT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. PER A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE, NO RELATED SYSTEM ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE." }, { "mdr_text_key": "323392033", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY MEDWATCH REPORT (MDR REPORT #MW5115834) WITH THE FOLLOWING EVENT DESCRIPTION: \"PATIENT HAD A ROBOTIC HYSTERECTOMY ON (B)(6) 2022 AT THE SURGICAL HOSPITAL SINCE HER SURGERY PATIENT HAD CONTINUED ABDOMINAL PELVIC PAIN. ON (B)(6) 2023, A CT WAS OBTAINED WHEN PATIENT PRESENTED TO THE ED AND THERE WAS CONCERN FOR A FOREIGN BODY. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A LAPAROSCOPIC REMOVAL OF FOREIGN BODY ON (B)(6) 2023. THE FOREIGN BODY WAS RETRIEVED AND IDENTIFIED AS A TIP COVER ACCESSORY PLACED OVER THE MONOPOLAR CURVED SCISSOR INSTRUMENT USED IN ROBOTIC PROCEDURES. THE INSTRUMENT USED ON (B)(6) 2022 WAS MONOPOLAR CURVED SCISSOR 8MM DA VINCI XI SERIAL NUMBER (B)(6). THE INSTRUMENT IS NO LONGER IN OUR INVENTORY. THE MONOPOLAR IS CONSIDERED A SEMIDISPOSABLE WHICH CAN BE USED UP TO 10 TIMES. IT WAS UTILIZED AGAIN ON (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, AND (B)(6) 2022.\" THE DATES OF THE CT SCAN AND THE ADDITIONAL PROCEDURE WERE NOT PROVIDED. IT WAS UNKNOWN IF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT WHILE THE MCS INSTRUMENT WAS BEING REMOVED, AFTER HAVING BEEN USED FOR THE ENTIRE PROCEDURE. IT WAS UNKNOWN WHAT CAUSED THE TIP COVER ACCESSORY TO SLIP OFF. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE INITIAL SURGICAL PROCEDURE. IT WAS UNKNOWN IF THE MCS INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS DURING THE INITIAL PROCEDURE. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE INITIAL PROCEDURE; IT WAS UNKNOWN WHETHER OR NOT THE INSTALLATION TOOL WAS USED, BUT ELECTROLUBE OR ANY OTHER LUBRICANT WERE NOT APPLIED TO THE MCS INSTRUMENT PRIOR TO THE INSTALLATION OF THE TIP COVER ACCESSORY. WHEN ASKED IF ANY PART OF THE ORANGE SURFACE WAS VISIBLE AFTER THE ACCESSORY WAS INSTALLED OR IF THE ACCESSORY WAS INSTALLED BEYOND THE ORANGE SURFACE (CAUSING A BULGE OVER THE SHAFT), THERE WAS NO RESPONSE. IT WAS UNKNOWN IF A REDUCER WAS USED. IT WAS ALSO UNKNOWN IF THERE WAS ANY DIFFICULTY IN REMOVING THE INSTRUMENT AND ACCESSORY, OR IF THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. FURTHERMORE, IT WAS UNKNOWN IF THE SURGICAL STAFF NOTICED ANY DAMAGE ON THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. THE INITIAL PROCEDURE WAS COMPLETED ROBOTICALLY, AND THE PATIENT IS CURRENTLY DISCHARGED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }