{ "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": "2955842-2023-20973", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20231206", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20231113", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20231206", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230727", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1772592", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231206", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480440-06", "catalog_number": "480440", "lot_number": "L14230727 0107", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20231121", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/21/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20231206", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "58 YR", "patient_sex": "Male", "patient_weight": "73 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20231113", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18275353", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231113", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "339995303", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "339995304", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FURTHER FAILURE ANALYSIS INVESTIGATION HAVE BEEN PERFORMED. THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND FOUND BOTH ENDS OF THE PIVOT PIN (MACHINED AS WELL AS SWAGED) LOOKED NORMAL. NO MANUFACTURING-RELATED DEFECTS WERE OBSERVED." }, { "mdr_text_key": "329843000", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SYNCHROSEAL INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM/REPRODUCE THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED DISTAL WASHER AT THE DISTAL END. THE DISTAL WASHER WAS RETURNED WITH THE INSTRUMENT. A REVIEW OF THE LOGS SHOWED NO ERRORS. ADDITIONAL OBSERVATION NOT REPORTED BY SITE THAT IS NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE A TORN JAW COVER. NO MISSING MATERIAL." }, { "mdr_text_key": "329843001", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SURGEON WAS USING A SYNCHROSEAL INSTRUMENT, AND IT WAS NOTICED THAT THE SCREW CAP FELL INTO THE BELLY OF THE PATIENT. NO DAMAGE WAS NOTED TO THE INSTRUMENT DURING PROCEDURE OR INSERTING/REMOVING INSTRUMENT DURING PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT USED ON 13-NOV-2023 DURING LOW ANTERIOR RESECTION (LAR) ON SYSTEM SK3872. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO NOTED DAMAGE. NO FUNCTIONALITY ISSUES NOTICED DURING USE. THE INSTRUMENT DID NOT COLLIDE WITH ANY INSTRUMENTS. NO X-RAYS PERFORMED AS THE FRAGMENT WAS VISIBLE AND RETRIEVED. THE PATIENT DID NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/19/2024" } ] }