{ "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": "2955842-2024-18783", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240903", "manufacturer_address_2": "", "pma_pmn_number": "K220023", "date_of_event": "20240805", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20240903", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240327", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1369599", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240903", "brand_name": "DA VINCI", "generic_name": "ACCESSORY, TIP COVER, DI", "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": "DA", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/06/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20240903", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20240805", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20124028", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240805", "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": "350763395", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP COVER ACCESSORY WAS POSSIBLY LEFT IN THE PATIENT. THE CUSTOMER BELIEVED THE MCS TIP COVER ACCESSORY FELL OFF INTO THE PATIENT. THE CUSTOMER WAS NOT ABLE TO LOCATE IT INSIDE OR OUTSIDE THE PATIENT. THE CUSTOMER DID AN X-RAYS TO SEE IF THEY COULD FIND IT IN THE PATIENT. THE PROCEDURE WAS COMPLETED." }, { "mdr_text_key": "350763396", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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 REPORTED THAT THE MCS TIP COVER ACCESSORY WAS MISSING. 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." }, { "mdr_text_key": "353066806", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "353066807", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 09/06/2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5158490 STATING THE FOLLOWING: \"ON (B)(6) 2024, A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY WAS COMPLETED UTILIZING THE INTUITIVE SURGICAL DAVINCI MONOPOLAR CURVE SCISSOR COVER TIP ACCESSORY. THOUGH THE FINAL SURGICAL COUNT WAS CORRECT, DURING THE BACK TABLE CLEAN STAFF RECOGNIZED THAT THIS RADIOLUCENT TIP COVER WAS NOT FOUND. THIS WAS AN UNEXPECTED FINDING DUE TO THE SNUG FIT AND HOW DIFFICULT IT IS TO EVEN INTENTIONALLY REMOVE THIS COVER. THE EVENT WAS REPORTED TO DAVINCI AND THEY CREATED AN ADVERSE EVENT (B)(4). THEIR TECH SUPPORT ON (B)(6) 2024 PROVIDED THIS RESPONSE ABOUT THE PRODUCT: \"THE MCS (MONOPOLAR CURVE SCISSOR) COVER TIP IS CONSIDERED RADIOLUCENT (TRANSPARENT ON THE XRAY). IF THE ENTIRE TIP COVER IS LEFT BEHIND, IT MAY APPEAR LIKE A MASS ON THE X -RAY \". THE EVENT WAS DISCLOSED TO THE PATIENT AND SHE AGREED TO UNDERGO AN ABDOMINAL CT WITH CONTRAST WHICH READ AS NEGATIVE FOR ANY FINDINGS THOUGHT TO BE A RETAINED TIP.\"" } ], "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": "09/20/2024" } ] }