{ "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": "2955842-2026-23389", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260430", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20260326", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "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": "", "date_added": "20260430", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "9713", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260430", "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", "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": [ "Material Separation" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/13/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260430", "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": [ "Abdominal Pain", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20260604", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25043092", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260401", "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": "403361589", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, G3, G6, H2, H9, AND H11. ADDITIONAL INFORMATION: THE SURGEON STATED THAT THE ORIGINAL SURGERY WAS A ROBOTIC HYSTERECTOMY PERFORMED IN 2014 IN (B)(6), THOUGH THE SPECIFIC HOSPITAL WAS NOT KNOWN. THE PATIENT HAS REPORTED THAT NO ADDITIONAL ABDOMINAL SURGERIES HAVE BEEN PERFORMED SINCE THAT TIME. A PHOTOGRAPH OF THE REMOVED SLEEVE WAS DOCUMENTED IN THE MEDICAL RECORD; THE PATIENT HAS PROVIDED PICTURES THAT MATCH THE DEVICE REMOVED, AND THESE IMAGES HAVE BEEN CONFIRMED TO BE IDENTICAL. AT THE TIME OF SURGERY, THE OBJECT REMOVED FROM THE PATIENT¿S BODY WAS EXAMINED AND COMPARED TO THE SLEEVE CURRENTLY USED WITH MONOPOLAR SCISSORS. THE COMPARISON SHOWED THE DEVICES TO BE THE SAME, ASIDE FROM SOME WEAR TO THE LETTERING, PRESUMABLY DUE TO AGE. IMAGE REVIEW: A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED, AND IT WAS CONFIRMED TO BE A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER." }, { "mdr_text_key": "403361590", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "399936046", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED DA VINCI SURGICAL PROCEDURE 12 YEARS AGO PRESENTED TO THE EMERGENCY DEPARTMENT WITH SEVERE ABDOMINAL PAIN. COMPUTED TOMOGRAPHY (CT) IMAGING FOUND A FOREIGN OBJECT, PROMPTING EXPLORATORY LAPAROSCOPY SPECIFICALLY TO REMOVE THE OBJECT. THE SURGEON RETRIEVED A FRAGMENT ALLEGED TO BE THE TIP COVER SHEATH FROM A MONOPOLAR CURVED SCISSORS INSTRUMENT. THE SURGEON STATED THAT THE PATIENT HAD EXPERIENCED CHRONIC ABDOMINAL PAIN, POSSIBLY ATTRIBUTABLE TO THE RETAINED FRAGMENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON REGARDING ANY AVAILABLE INFORMATION REGARDING THE INITIAL ROBOTIC SURGERY AVAILABLE (E.G.; TYPE OF SURGERY PERFORMED, DATE HOSPITAL NAME); HOWEVER, NO ADDITIONAL INFORMATION IS PROVIDED." }, { "mdr_text_key": "399936047", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOREIGN OBJECT WAS GIVEN TO THE PATIENT AT THEIR REQUEST AND IS NOT AVAILABLE FOR ANALYSIS. NO INFORMATION WAS PROVIDED FOR THE DA VINCI SYSTEM MODEL, USER FACILITY NAME, DATE AND TYPE OF PROCEDURE OR SURGEON¿S NAME. THEREFORE, AN INVESTIGATION CANNOT BE PERFORMED, AND A POTENTIAL ROOT CAUSE CANNOT BE DETERMINED. THERE IS AN IMAGE AVAILABLE FOR REVIEW: HOWEVER, THE SURGEON DECLINED TO PROVIDE THAT WITHOUT THE PATIENT¿S CONSENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/04/2026" } ] }