{ "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": "2955842-2024-18203", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240822", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20240724", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20240822", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231102", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "17620", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240822", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480440-06", "catalog_number": "480440", "lot_number": "L12231102 0263", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240816", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)251130(10)L12231102", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/04/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "health_professional": "", "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": "20240822", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20240724", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20031216", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240724", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "349884401", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE WASHER DISLODGED FROM ITS ORIGINAL POSITION AND NOT ATTACHED TO THE INSTRUMENT. THE INSTRUMENT WAS COMPARED TO AN IN-HOUSE GOLDEN SYNCHROSEAL, AND THE WASHER WAS FOUND TO BE MISSING. THE MISSING PIECE WAS NOT RETURNED WITH THE INSTRUMENT. THE MISSING PIECE MEASURES 0.110\" IN DIAMETER. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY ISI. THE IMAGE IS CONSISTENT WITH THE ALLEGED COMPLAINT: THE PIVOT PIN WASHER WAS DETACHED." }, { "mdr_text_key": "349884402", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY (RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT A WASHER APPROXIMATELY 5 MILLIMETERS WAS FOUND INSIDE THE PATIENT¿S ANATOMY. THE SURGEON WAS ABLE TO REMOVE THE WASHER FROM THE BODY. THE CUSTOMER STATED THAT THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WAS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1, 30-DEGREE ENDOSCOPE WAS INSTALLED ON USM 2, LARGE NEEDLE DRIVER (LND) WAS INSTALLED ON USM 3, AND SYNCHROSEAL INSTRUMENT WAS INSTALLED ON USM 4. THE CUSTOMER REVIEWED THE VIDEO RECORD AND CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT CAUSING A WASHER DETACHMENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS REMOVED USING A LAPAROSCOPIC INSTRUMENT. THE CUSTOMER REVIEWED THE VIDEO RECORD AND CONFIRMED THAT ALL FRAGMENT WAS REMOVED, AND ONLY THE WASHER FELL INTO THE PATIENT. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TEST WAS PERFORMED. THE NURSE STATED THAT THERE WAS NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT AND THE FRAGMENT WILL BE RETURNED." }, { "mdr_text_key": "353927793", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "353927794", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FURTHER ENGINEERING INVESTIGATION WAS PERFORMED: INITIAL FINDINGS WERE CONFIRMED. THE WASHER WAS FOUND TO BE MISSING FROM ONE END OF THE PIVOT PIN. THE JAW COVER WAS FOUND TO HAVE TEARS AS WELL. THE JAW COVER WAS REMOVED DURING AFA, AND IT WAS NOTICED THAT THE WASHER AT THE SWAGED END OF THE PIVOT PIN WAS STILL INTACT, AND THE MISSING WASHER GOT DISLODGED FROM THE MACHINED END. DURING VISUAL INSPECTION, BOTH ENDS OF THE PIN LOOKED FINE AND NO MANUFACTURING RELATED ISSUES (INSUFFICIENT SWAGE OR MACHINING PROBLEMS) WERE IDENTIFIED. THE OD OF THE MACHINED END WAS ALSO WITHIN SPECIFICATION. SINCE THE DISLODGED WASHER WAS NOT RETURNED WITH THE INSTRUMENT, NO MEASUREMENTS FOR ITS INNER DIAMETER COULD BE DONE. THE DISTAL END EXHIBITED SOME USER RELATED DAMAGE (SCRATCHES ON JAWS ETC.) IN ADDITION TO THE JAW COVER TEARS OBSERVED DURING INITIAL FA, LOGS SHOWED THAT THE INSTRUMENT WAS USED FOR OVER AN HOUR." } ], "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": "10/11/2024" } ] }