{ "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": "2955842-2025-20918", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250519", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250416", "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", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20250519", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240201", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1932291", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250519", "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": "L81240201", "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(10)L81240201", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Separation", "Material Separation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/15/2025;06/23/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250813", "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": "20250519", "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": "20250422", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22043292", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250422", "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": "370550233", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: ALL THREE TIP COVERS APPEAR TO HAVE TEARS AT THE DISTAL END OF THE ACCESSORY WHERE THE SCISSOR PORTION OF THE INSTRUMENT EXITS. THE TOP TIP COVER APPEARS TO HAVE A TEAR ISOLATED TO THE CLEAR PORTION. THE MIDDLE TIP COVER APPEARS TO HAVE A TEAR THAT EXTENDS THROUGH THE CLEAR PORTION AND POSSIBLY ENDS AT THE GREY PORTION, BUT THE ACCESSORY WOULD NEED TO BE RETURNED IN ORDER TO CONFIRM. THE BOTTOM TIP COVER APPEARS TO HAVE A TEAR THAT EXTENDS INTO THE GREY PORTION OF THE ACCESSORY. MANUFACTURER REPORT NUMBERS 2955842-2025-20548 AND 2955842-2025-18655 DOCUMENT THE TWO OTHER TIP COVERS." }, { "mdr_text_key": "370550234", "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 WAS FOUND BROKEN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTED THE TIP COVER WAS BROKEN AND AFTER INSPECTION, BEFORE USE, NO ABNORMALITY WAS FOUND. THE ANATOMICAL TISSUE WAS BEING DISSECTED. THE SURGEONS BELIEVED THAT THE QUALITY PROBLEM CAUSED THE TIP COVER TO RUPTURE, AND IT TOOK ABOUT 50 MINUTES BEFORE THE TIP COVER BROKE. THE SURGEON DIDN'T NOTICE ANYTHING WRONG WITH THE INSTRUMENT, AND IT DID NOT COLLIDE DURING THE OPERATION. NO FRAGMENT(S) FELL INTO THE PATIENT DURING A COLLISION, AND ALL WAS CORRECTED BEFORE REMOVING THE EQUIPMENT. THE OPERATOR FELT NO RESISTANCE WHEN REMOVING THE INSTRUMENT. THE WRIST OF THE INSTRUMENT IS STRAIGHT. THERE WAS NO RESISTANCE WHEN THE OPERATOR REMOVED THE INSTRUMENT. THERE WAS NO DAMAGE TO THE INSTRUMENT CHANNEL. THE OPERATOR DID NOT FIND ANY DAMAGE TO THE INSTRUMENT, AND ALL THE FRAGMENTS WERE RECOVERED AND CONFIRMED BY THE OBSERVATION OF THE OPERATING PERSONNEL. THE ASSISTANT RETRIEVED THE FRAGMENTS THROUGH THE LAPAROSCOPY INSTRUMENT, AND NO EXTRA TESTS WERE DONE. THE PROCEDURE WAS COMPLETED THE OPERATION BY ROBOT WITH NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE FRAGMENTS HAVE BEEN SENT TO INTUITIVE SURGICAL, INC. (ISI)." }, { "mdr_text_key": "371670768", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 15-MAY-2025, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: FURTHER FOLLOW-UP WAS PERFORMED, THE CUSTOMER CONFIRMED THAT ONLY THE TIP COVER WAS TORN, AND NO FRAGMENT FELL INTO THE PATIENT'S BODY." }, { "mdr_text_key": "371670769", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "374853590", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "374853591", "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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ANALYZED AND FOUND TO HAVE TEARING AT THE MOUTH ON THE DISTAL END. THE TEAR IS AXIALLY ALIGNED WITH THE TIP COVER AND MEASURES APPROXIMATELY 0.2210¿ IN LENGTH. THERE ARE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. THE MCS INSTRUMENT REQUIRES THE USE OF A TIP COVER TO PREVENT ENERGY FROM DISCHARGING ANYWHERE BUT AT THE INSTRUMENT¿S 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": "06/04/2025;06/24/2025" } ] }