{ "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": "Death", "report_number": "2955842-2024-21591", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20241105", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20241007", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20241105", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230831", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1598792", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241105", "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": "L13230831 0250", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20241011", "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)250831(10)L13230831", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Unintended System Motion", "Unintended System Motion" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/26/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "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": "20241105", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20241007", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20607620", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241007", "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": "355842591", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MEDWATCH REPORT REPRESENTS THE SYNCHROSEAL INSTRUMENT. SEE SECTION H10 RELATED REPORT NUMBER FOR THE USM3 ARM DEVICE. AN INTUITIVE FIELD SERVICE ENGINEER (FSE) TESTED THE DA VINCI SYSTEM ON SITE AND COULD NOT REPRODUCE THE REPORTED ERRORS. DURING TESTING, THE FSE NOTICED SLIGHT RESISTANCE ON USM3, REPLACED IT, AND THE SYSTEM WAS VERIFIED READY FOR USE. THE SYNCHROSEAL LOGS FOUND THAT THE FIRST SYNCHROSEAL INSTRUMENT WAS USED FOR ABOUT 3 HOURS WITHOUT ERRORS. THE SECOND SYNCHROSEAL INSTRUMENT WAS USED FOR ABOUT 22 MINUTES WITHOUT ERRORS. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: 30 DEGREE ENDOSCOPE PLUS, MONOPOLAR CURVED SCISSORS, PERMANENT CAUTERY HOOK, TWO LARGE CLIP APPLIERS, TWO MEDIUM-LARGE CLIP APPLIERS, FENESTRATED BIPOLAR FORCEPS, MEGA SUTURECUT NEEDLE DRIVER, TWO SYNCHROSEALS, SUREFORM STAPLER 60, MARYLAND BIPOLAR FORCEPS, SUCTION IRRIGATOR. A SITE HISTORY REVIEW FOUND NO RELATED COMPLAINTS WERE RECEIVED FOR THE OTHER INSTRUMENTS USED DURING THIS PROCEDURE. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE DEVICE(S) USED DURING THE PROCEDURE FOUND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS EVENT. A REVIEW OF THE SYSTEM LOGS FOUND THAT NO RELEVANT ERRORS OCCURRED DURING THE PROCEDURE. LOG REVIEW OF THE 5 SUBSEQUENT PROCEDURES PERFORMED ON THE SYSTEM FOUND NO ERRORS OCCURRED THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT IN THIS REPORT WAS UNDERGOING A PANCREATICODUODENECTOMY WHEN THEY GOT INTO BLEEDING. HOW THEY GOT INTO THE BLEEDING IS NOT REPORTED BUT THEY OPENED AND WERE UNABLE TO CONTROL THE HEMORRHAGE. THE PATIENT ULTIMATELY DIED FROM THIS EVENT. NO ALLEGATION OF ANY INJURY OR MALFUNCTION OF ANY INTUITIVE SURGICAL PRODUCT OR INSTRUMENT HAS BEEN MADE. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT. ." }, { "mdr_text_key": "355842592", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY PROCEDURE, AN UNSPECIFIED VESSEL WAS DAMAGED LEADING TO BLEEDING. THE PROCEDURE WAS CONVERTED TO OPEN; THE PATIENT ULTIMATELY EXPIRED. AN INTUITIVE CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT IN THE OR DURING THE PROCEDURE REPORTED THAT WHEN THE INJURY TO THE VESSEL OCCURRED, THE SURGEON CLAMPED THE BLEEDING VESSEL WITH A ROBOTIC INSTRUMENT. THE SURGEON STATED THAT DURING THE OPEN PROCEDURE THEY COULD NOT OBTAIN FULL CONTROL OF THE BLEEDING. CHEST COMPRESSIONS WERE PERFORMED, BUT THE PATIENT EXPIRED ON THE OR TABLE. THE SURGEON STATED THAT, \"THE COMPLICATION WAS NOT RELATED TO THE DEVICES BUT TO [THE] COMPLEXITY OF THE SURGERY AND DEGREE OF CANCER.\" COINCIDENTALLY, PRIOR TO THE VESSEL INJURY EVENT, THE CTA CALLED INTUITIVE TECHNICAL SUPPORT ENGINEERING (TSE) TO REPORT THAT WHEN SWAPPING INSTRUMENTS, THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM ARM3) WOULD JUMP MORE THAN NORMAL AND WOULD CANCEL GUIDED TOOL CHANGE (GTC). THE (TSE) REVIEWED THE SYSTEM LOGS AND FOUND NO RELATED ERRORS AT THE TIME OF THE CALL. THE CTA ALSO REPORTED A SYNCHROSEAL INSTRUMENT IN USE ON USM ARM3 COULD ONLY ROTATE TO THE RIGHT. THE TSE DID NOT OBSERVE ANY ERRORS IN THE SYSTEM LOGS RELATED TO THE INSTRUMENT. THE SURGEON ELECTED TO REPLACE THE SYNCHROSEAL INSTRUMENT ON ARM3 AND CONTINUED THE PROCEDURE ROBOTICALLY AT THAT TIME. THE SURGEON REPORTED THAT THE COINCIDENTAL USM3 AND SYNCHROSEAL ISSUES DID NOT CONTRIBUTE TO THE VESSEL INJURY." }, { "mdr_text_key": "359348255", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MEDWATCH REPORT REPRESENTS THE SYNCHROSEAL INSTRUMENT. SEE SECTION H10 RELATED REPORT NUMBER FOR THE USM3 ARM DEVICE. CORRECTION: THE INVESTIGATION ADVERSE EVENT PROBLEM CODES WERE SUBMITTED IN MEDWATCH FOLLOW-UP #1; THE FOLLOWING INVESTIGATION NARRATIVE WAS INADVERTENTLY OMITTED. THE SYNCHROSEAL INSTRUMENT USED DURING THIS PROCEDURE WAS RECEIVED. THE INSTRUMENT WAS FOUND TO HAVE A LOOSE SCREW INSIDE OF THE HOUSING. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A LOOSE SNAKE WRIST CABLE AT THE PROXIMAL END. AS A RESULT, THE CABLES WERE SLIGHTLY LOOSE WHICH CAUSED THE INSTRUMENT TO FAIL INTUITIVE MOTION." }, { "mdr_text_key": "359348256", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "12/17/2024" } ] }