{ "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": "2955842-2026-20616", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260407", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250310", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", 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"", "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": "20260407", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20260407", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24800499", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260316", "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": "397642211", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY APPLICATION TOOL HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "397642212", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN ONE YEAR AFTER THE SURGERY AND AN OBJECT WAS IDENTIFIED, THEY HAD THE SIZE AND SHAPE OF THE OBJECT AND CONFIDENT IT IS THE REPLACEMENT TOOL FOR THE MONOPOLAR CURVED SHEARS INSULATION, THE SILICONE APPLICATOR, AND THEY BELIEVE SOMEBODY LEFT IT ON WHEN THEY PLACED IT THROUGH A 12 MM PORT AND THEIR ASSUMPTION IS IT FELL OFF WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED. NO INTERVENTION WAS NOTED, AND THE PATIENT WAS REPORTEDLY DOING FINE AND ASYMPTOMATIC. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE RETAINED ITEM WAS NOT THE TIP COVER. RATHER, IT WAS THE CLEAR APPLICATOR TOOL TO APPLY AND REMOVE THE TIP COVER. THE CUSTOMER WAS NOT PLANNING TO RETURN THE APPLIER; IT IS REMAINING INSIDE OF THE PATIENT." } ], "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": "" } ] }