{ "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": "2955842-2026-21729", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260422", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20260330", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "117", "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": "20260422", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20260211", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1018697", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260422", "brand_name": "DA VINCI", "generic_name": "SEAL", "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": "470500-14", "catalog_number": "470500", "lot_number": "K15260211", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260418", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874116408", "udi_public": "(01)10886874116408(10)K15260211", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Separation" ], "reporter_state_code": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260702", "health_professional": "", "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": "20260422", "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" ] } ], "distributor_city": "", "date_report": "20260422", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24955873", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260330", "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": "399139020", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A BLACK FRAGMENT FROM A UNIVERSAL SEAL CAME OFF AND FELL INTO THE PATIENT. THE SURGEON WAS ABOUT ¾ COMPLETED WITH THE PROCEDURE WHEN A PIECE OF THE UNIVERSAL SEAL WAS OBSERVED TO HAVE FALLEN OFF AND WAS VIEWABLE IN THE PATIENT ANATOMY. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE WITH NO INJURY OR HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, THE UNIVERSAL SEAL WAS INSPECTED AND PLACED ON THE TROCAR, WITH NO ABNORMALITIES OBSERVED AT THAT TIME. THE TROCAR, POSITIONED IN ARM #4 (THE SURGEON'S RIGHT ARM), WAS EXCHANGED MULTIPLE TIMES FOR SCISSORS, CLIPS, AND A NEEDLE HOLDER INSTRUMENTS. IT IS UNCLEAR EXACTLY WHEN THE FRAGMENT FELL INTO THE PATIENT. THE UNIVERSAL SEAL WAS IN USE FOR APPROXIMATELY 2 HOURS. THE SURGEON IS UNCERTAIN WHAT CAUSED THE PIECE TO FALL OFF. THE PORT REMAINED IN PLACE UNTIL THE END OF THE PROCEDURE AND FUNCTIONED PROPERLY THROUGHOUT THE PROCEDURE, WITH NO INDICATION OF A SEAL MALFUNCTION. THE FRAGMENT WAS SUBSEQUENTLY RETRIEVED USING A LAPAROSCOPIC GRASPER, AND ALL PIECES WERE ACCOUNTED FOR AND CONFIRMED AT THE COMPLETION OF THE PROCEDURE. RETRIEVAL DID NOT REQUIRE ANY ADDITIONAL STEPS BEYOND STANDARD PRACTICE. THE OPERATION WAS COMPLETED ROBOTICALLY, AND NO INJURY OR COMPLICATION RESULTED FROM THE INCIDENT. THE PATIENT WAS DISCHARGED AFTER 1¿2 DAYS POSTOPERATIVELY, NOT AS A RESULT OF THE DEVICE ISSUE." }, { "mdr_text_key": "399139021", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SEAL TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SEAL WAS FOUND TO HAVE TORN BLACK RUBBER DUCKBILL. THE BLACK RUBBER DUCKBILL WAS TORN, AND ALTHOUGH A PIECE WAS RETURNED WITH THE SEAL, SOME FRAGMENTS MAY STILL BE MISSING, INDICATING THAT A PORTION COULD HAVE DETACHED FROM THE SEAL." } ], "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": "" } ] }