{ "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": "2955842-2025-33710", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250813", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250715", "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": [ "Foreign", "Study", "Literature", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250813", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "373168", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250813", "brand_name": "DA VINCI SYSTEMS", "generic_name": "STAPLER SUFEFORM-45", "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": "480545", "catalog_number": "480545", "lot_number": "UNKNOWN", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/19/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260209", "health_professional": "Y", "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": "20250813", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "85 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260113", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22791152", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250715", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "377500953", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: NONE PROVIDED" }, { "mdr_text_key": "377500954", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE TITLED: \"PROS AND CONS OF DA VINCI CURVED-TIP STAPLER HOSPITAL: MINAMI TOHOKU GENERAL HOSPITAL, DEPARTMENT OF THORACIC SURGERY\" WAS PERFORMED. THE ARTICLE DISCUSSED A DA VINCI-ASSISTED RIGHT UPPER LOBECTOMY PROCEDURE PERFORMED ON A 85-YEAR-OLD-FEMALE PATIENT. WHEN DISSECTING THE UPPER AND LOWER LOBES, A SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT, WITH A GREEN SUREFORM 45 RELOAD INSTALLED, WAS INSERTED AFTER PASSING A PENROSE DRAIN BETWEEN THE LOBES. THE SURGEON THOUGHT THE STAPLER INSTRUMENT SLID DIRECTLY ABOVE THE PENROSE DRAIN, BUT THE TIP OF THE STAPLER INSTRUMENT HAD PIERCED THE LUNG. THERE WAS NO BLEEDING OBSERVED, SO THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT WAS INSERTED AGAIN AND USED TO DISSECT THE REMAINING LOBES. THE FOLLOWING INFORMATION IS UNKNOWN: IF LUNG TISSUE WAS ACTUALLY INJURED/DAMAGED AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. THE ARTICLE MENTIONED THAT SURGEONS SHOULD PAY ATTENTION TO THE DIRECTION OF THE STAPLER INSTRUMENT'S TIP AND THAT CARE MUST BE TAKEN WHEN THE FIELD OF VIEW IS POOR, DISSECTION IS INSUFFICIENT, OR THE BLOOD VESSELS BRANCH. THE AUTHORS CONCLUDED THAT THE TIP OF THE ANVIL OF THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT IS BENT AT ABOUT 30 DEGREES AND THIS BEND SHOULD BE TAKEN INTO CONSIDERATION DURING INSTALLATION SINCE THE TIP MAY DAMAGE BLOOD VESSELS OR LUNGS." }, { "mdr_text_key": "390305646", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "390305647", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: E1, E3, G2, H2, H3, AND H11. CORRECTED DATA: E1, E3, AND G2 FIELDS. ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT, BUT THE EVENT HAD NO PATIENT INJURY AND THE PATIENT WAS DISCHARGED WITHOUT A PROBLEM. PER THE PHYSICIAN, THERE WERE NO DEVICE ISSUES AND NO INJURY CAUSED BY THE DA VINCI SURGICAL SYSTEM." } ], "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": "01/13/2026" } ] }