{ "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": "2955842-2025-48075", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251219", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250926", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20251219", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250508", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "578965", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251219", "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": "400180-16", "catalog_number": "400180", "lot_number": "K12250508", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(17)270212(10)K12250508", "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": "01/13/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260309", "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": "20251219", "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": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260211", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23849902", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251130", "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": "388114497", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP COVER ACCESSORY WAS RECEIVED BUT FAILURE ANALYSIS HAS NOT BEEN COMPLETED." }, { "mdr_text_key": "388114498", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY BECAME LOOSE AND FELL INTO THE PATIENT'S BODY. THE ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: PRIOR TO USE, BOTH THE INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED AND FOUND TO BE IN NORMAL CONDITION WITH NO DAMAGE OBSERVED. DURING THE PROCEDURE, THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT WHILE THE SURGICAL TASK OF INSTRUMENT EXCHANGE¿SPECIFICALLY SWITCHING TO A LARGE NEEDLE DRIVER¿WAS BEING PERFORMED. THE ACCESSORY WAS SUBSEQUENTLY RETRIEVED USING THE ASSISTANT PORT (12MM). THE SURGEON BELIEVES THAT THE ACCESSORY SLIPPED OFF OR BROKE DUE TO A DEFECTIVE PRODUCT. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD BEEN IN USE FOR OVER 60 MINUTES AT THE TIME OF THE EVENT. NO ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT WERE NOTICED DURING THE PROCEDURE, NOR WAS THERE ANY COLLISION WITH OTHER INSTRUMENTS. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING SURGERY, WITH SOME OF THE ORANGE SURFACE VISIBLE, WHICH IS EXPECTED. THE ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE (AVOIDING OVER-INSTALLATION), AND THE INSTALLATION TOOL WAS EMPLOYED DURING SETUP. NO ELECTROLUBE OR OTHER LUBRICANT WAS APPLIED BEFOREHAND. ADDITIONALLY, A REDUCER WAS NOT USED IN THIS CASE. THERE WAS RESISTANCE NOTED WHEN REMOVING THE INSTRUMENT AND TIP COVER ACCESSORY THROUGH THE CANNULA, DESPITE THE INSTRUMENT'S WRIST BEING STRAIGHTENED UPON REMOVAL. AFTER THE EVENT, THE SURGICAL STAFF DID NOT OBSERVE ANY DAMAGE TO THE MCS TIP COVER ACCESSORY, THE INSTRUMENT, OR THE CANNULA. TO COMPLETE THE PROCEDURE, A NEW TIP COVER WAS CHANGED, AND SURGERY CONTINUED ROBOTICALLY. THE MCS TIP COVER ACCESSORY IS AVAILABLE AND WILL BE RETURNED TO ISI FOR EVALUATION, WHILE THE MCS INSTRUMENT ITSELF IS NOT AVAILABLE FOR RETURN. THERE ARE NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS AVAILABLE FOR ISI REVIEW OF THIS INCIDENT." }, { "mdr_text_key": "393315754", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 8MM MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ANALYZED, AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. USING THE INSTALLATION TOOL, THE TIP COVER WAS PLACED ON A MCS (470179-21). THE TIP COVER WAS TIGHTLY ATTACHED TO THE SCISSOR AND COULD ONLY BE REMOVED WITH CONSIDERABLE EFFORT. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE TIP COVER WAS FOUND TO HAVE TEARING IN THE TRANSPARENT PART AT THE MOUTH WHERE THE SCISSOR TIPS EXIT AND ALSO THE GREY PART DID SHOW DAMAGE. THE TEARS WERE AXIALLY ALIGNED WITH THE TIP COVER AND MEASURED FROM 3 MM TO 1 MM IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS." }, { "mdr_text_key": "393315755", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "02/11/2026" } ] }