{ "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": "2955842-2023-19426", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20231019", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20230927", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20231020", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230112", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "539163", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231019", "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": "400180-14", "catalog_number": "400180", "lot_number": "L80230112", "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)L80230112", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Split, Cut or Torn", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/22/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20231019", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "64 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230927", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17971322", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230927", "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": "338983125", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "338983126", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM AND REPRODUCE THE CUSTOMER REPORTED COMPLAINT. THE MCS TIP COVER WAS FOUND TO HAVE TEARING AT THE MOUTH ON THE DISTAL END. THE TEARS WERE AXIALLY ALIGNED WITH THE TIP COVER AND MEASURED FROM 4.02MM TO 2.48MM IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS." }, { "mdr_text_key": "326125068", "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 WAS CUT IN THE PATIENT¿S ABDOMEN AFTER A FEW MINUTES OF USE. THE TIP COVER WAS EXCHANGED. THE CUSTOMER NOTED THAT IT IS POSSIBLE THAT A FRAGMENT REMAINED IN THE ABDOMEN. THIS EVENT INCREASED THE PROCEDURE TIME 10-15 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS AND TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS FOUND AS IT WAS A NEW PRODUCT. THERE WERE NO VISIBLE FRAGMENTS. NO ADDITIONAL SURGERY WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS SUCH AS AN X-RAY OR ULTRASOUND PERFORMED TO CHECK IF ANY FRAGMENTS REMAINED. THE TASK PERFORMED AT THE TIME THE SHEATH WAS CUT WAS DISSECTION. THE SURGEON DID NOT KNOW WHAT CAUSED THE SHEATH TO RUPTURE. THE MCS WAS IN USE FOR FIVE MINUTES. THE SURGEON DID NOT NOTICE ANY PROBLEMS WITH THE FUNCTIONING OF THE SCISSORS DURING THE SURGICAL PROCEDURE. THE SCISSORS DID NOT COLLIDE WITH OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE. THE MCS PROTECTIVE CAP APPEARED TO HAVE BEEN INSTALLED CORRECTLY. NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER INSTALLING THE TOE CAP. THE CAP WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED. NO ELECTROLUBE OR ANY OTHER LUBRICANT WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO THE INSTALLATION OF THE MCS TIP COVER ACCESSORY. A REDUCER WAS NOT USED. IT WAS UNKNOWN IF IMAGES/VIDEOS WERE AVAILABLE FOR ISI REVIEW. A FRAGMENT WILL NOT BE RETURNED AS THERE WERE NO FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POSTOPERATIVE COMPLICATIONS RELATED TO FOREIGN BODY RETENTION." }, { "mdr_text_key": "326125069", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED." } ], "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": "12/08/2023" } ] }