{ "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": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "24660946", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260323", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20260130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "RISK MANAGER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260324", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "732244", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260323", "brand_name": "DA VINCI ROBOT", "generic_name": "SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT", "manufacturer_d_name": "INTUITIVE SURGICAL, INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "DV5 ROBOT", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260210", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "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" } } ], "reporter_state_code": "MT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20260504", "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": "20260323", "sequence_number_treatment": [ "REF: 470-318, LOT: K10250424 0184, VERSION 15 SMALL GRASPING RETRACTOR," ], "sequence_number_outcome": [ "Required Intervention", " H", " L" ], "patient_age": "81 YR", "patient_sex": "Female", "patient_weight": "804 KG", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Bowel Perforation", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20260213", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "24660946", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "User Facility report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "396341932", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "INITIAL SURGERY PERFORMED: (B)(6)2026- ROBOTIC HYSTERECTOMY WITH SALPINGO-OOPHORECTOMY, TOT SLING, CYSTOSCOPY. PATIENT HAD COMPLICATIONS FOLLOWING SURGERY AND WAS TAKEN BACK TO THE OPERATING ROOM ON (B)(6) 2023. DURING THAT SURGERY A SMALL THIN METALLIC FOREIGN BODY WAS FOUND IN THE PATIENT'S ABDOMEN. THE PATIENT HAD A PERFORATED COLON. IT IS UNKNOWN IF THE WIRE WAS THE DIRECT CAUSE OF THE PERFORATION. IT IS BELIEVED TO HAVE COME FROM THE CABLE THAT IS USED WITH ONE OF THE ROBOTIC ARMS. ADD'L DEVICES: REF: 470-179, LOT: K14250913 0700, VERSION 23 MONOPOLAR CURVED SCISSOR; REF: 470-194, LOT: K10250501 0265, VERSION 9 MEGA NEEDLE DRIVER; REF: 471-309, LOT: K13251028 0471, VERSION 17 MEGA SUTURE CUT NEEDLE DRIVER; REF: 471-296, LOT: K10250925 0121, VERSION 10 LARGE SUTURE CUT NEEDLE DRIVER; REF: 471-093, LOT: K10241205 0112, VERSION 14 PRO-GRASP FORCEPS; REF: 470-318, LOT: K10250424 0184, VERSION 15 SMALL GRASPING RETRACTOR." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }