{ "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": "2955842-2025-26307", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250620", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250507", "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", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20250620", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240722", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "707437", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250620", "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": "L80240722", "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": "10886874111045", "udi_public": "(01)10886874111045(10)L80240722", "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": "07/07/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250731", "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": "20250620", "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": "20250526", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22302050", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250526", "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": "373157216", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL W/LYMPHADENECTOMY PROSTATECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OFF FROM THE SCISSORS AND FELL INTO THE PATIENT; THE GREY PART OF THE SCISSOR WAS DAMAGED AND COULD APPRECIATE THE ORANGE PART. THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGED WAS NOTICED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED BY THE FIRST ASSISTANT WITH A LAPAROSCOPIC INSTRUMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS DURING THE PROCEDURE AND THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED. NO INFORMATION OF THE SURGICAL TASK WAS AVAILABLE, AND THE SURGEON DID NOT KNOW THE CAUSE OF THE ISSUE. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE AND NO ORANGE SURFACE WAS VISIBLE AFTER BEING INSTALLED. THE INSTALLATION TOOL WAS USED, NO LUBRICANT WAS APPLIED PRIOR TO INSTALLATION, AND THE REDUCER WAS NOT USED. THERE WAS NO DIFFICULTY WHEN REMOVING THE MCS AND THE TIP COVER. THE MCS WRIST WAS STRAIGHTENED UPON REMOVAL. SURGICAL STAFF NOTICED A SMALL ORANGE MARK WHERE THE TIP COVER WAS PLACED. THE MCS TIP COVER ACCESSORY IS NOT AVAILABLE FOR RETURN." }, { "mdr_text_key": "373157219", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WILL NOT BE RETURNED FOR FAILURE ANALYSIS EVALUATION. AN IMAGE WAS PROVIDED OF THE TIP COVER ACCESSORY PACKAGING." }, { "mdr_text_key": "375081951", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "375081952", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE TIP COVER WAS NOT RETURNED. A MOVEMENT TEST WAS CARRIED OUT ON THE SYSTEM WITH A NEW TIP COVER. THE NEW TIP COVER WAS FIRMLY ATTACHED TO THE SCISSOR AND COULD ONLY BE REMOVED WITH GREAT EFFORT AFTER THE TEST. BASED ON THIS TEST, IT IS NOT POSSIBLE TO DETERMINE WHY THE TIP COVER SLIPPED OFF THE MCS DURING THE SURGERY. THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS RECEIVED FOR FAILURE ANALYSIS. THE INSTRUMENT EXHIBITED SCRATCH MARKS/ABRASIONS ON THE BROWN LASER MARKED SECTION OF THE TUBE EXTENSION. AS A RESULT, THE ORANGE PLASTIC BENEATH THE LASER MARKING WAS EXPOSED. TUBE EXTENSION SCRATCH MARKS MEASURED ROUGHLY 16.2 MM." } ], "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": "07/16/2025" } ] }