{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2021-10509", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20210518", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210419", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210518", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "736235", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210518", "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": "480440-05", "catalog_number": "480440", "lot_number": "T90200611 0195", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)220630(10)T90200611", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Deliver Energy", "Intermittent Energy Output", "Failure to Deliver Energy", "Intermittent Energy Output" ], "reporter_state_code": "UT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20210518", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "49 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Perforation of Vessels", "Hemorrhage/Blood Loss/Bleeding", "Perforation of Vessels" ] } ], "distributor_city": "", "date_report": "20210419", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11839533", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20210419", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "265804074", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS EVENT IS BEING REPORTED BECAUSE A VESSEL REPORTEDLY STARTED BLEEDING WHILE BEING SEALED WITH THE SYNCHROSEAL INSTRUMENT. THE VESSEL THAT BLED WAS REPORTED TO HAVE BEEN LESS THAN 5MM IN SIZE. INSTRUMENT LOG REVIEW: THE LOGS OF THIS PROCEDURE WERE REVIEWED. THE ENDOSCOPE AND FORCE BIPOLAR USED DURING THIS PROCEDURE HAVE BOTH BEEN USED IN A SUBSEQUENT PROCEDURE. THE SMALL GRASPING RETRACTOR HAD NOT BEEN USED IN A SUBSEQUENT PROCEDURE. THE SYNCHROSEAL INSTRUMENT IS A SINGLE USE INSTRUMENT AND COULD NOT BE USED IN SUBSEQUENT PROCEDURES. A SITE HISTORY REVIEW WAS PERFORMED, AND NO COMPLAINTS HAVE BEEN CREATED FOR THE INSTRUMENTS USED DURING THE PROCEDURE. SYNCHROSEAL LOG REVIEW: AN ADVANCED INSTRUMENT LOG REVIEW WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER AND THE FOLLOWING INFORMATION WAS PROVIDED: \"NO ERROR MESSAGES WERE STORED THROUGHOUT THE PROCEDURE...THERE ARE NO OBVIOUS GAPS OR ANYTHING THAT WOULD POTENTIALLY HELP US ESTIMATE WHERE THE INCIDENT OCCURRED. THE SYNCHROSEAL WAS ON USM3 FOR A COUPLE MINUTES, BUT WAS SWITCHED TO USM 4 BEFORE IT WAS ACTUALLY USED FOR ANY ENERGY DELIVERY. UNFORTUNATELY WITHOUT AN EXACT TIME OR PROCEDURE VIDEO, I AM UNABLE TO TELL WHAT ENERGY MODE WAS BEING USED WHEN THE BLEED HAPPENED.\" THIS EVENT HAS BEEN DEEMED REPORTABLE AS THE CUSTOMER REPORTED THAT THE SYNCHROSEAL INSTRUMENT DID NOT SUFFICIENTLY SEAL THE VESSEL IN THE INSTRUMENT JAWS CAUSING THE VESSEL TO BREAK AND BLEED." }, { "mdr_text_key": "265804075", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SPLENECTOMY PROCEDURE, BLEEDING OCCURRED. THE SURGEON REPORTED THAT HE THINKS HE GRABBED A VEIN WHICH CAUSED THE BLEEDING. THE SITE GAVE THE PATIENT A BLOOD TRANSFUSION AND CONVERTED TO OPEN SURGERY. THE SURGEON REPORTED TWO DAYS AFTER THE PROCEDURE THAT THE PATIENT WAS DOING FINE. THE SURGEON REPORTED THAT HE DOES NOT BELIEVE AN INTUITIVE SURGICAL INC. (ISI) PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED INJURY. FOLLOW-UP: ON 04/22/2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CONSOLE SURGEON OF THE PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE BLEEDING EVENT OCCURRED WHILE TAKING THE SPLENIC MINOR ATTACHMENT WITH THE SYNCHROSEAL INSTRUMENT. THE SURGEON SAID WHILE HE WAS SEALING TISSUE BLOOD STARTED FLOWING FROM IT. THE SURGEON CLARIFIED THAT THE BLOOD APPEARED WHILE THE SYNCHROSEAL INSTRUMENT WAS SEALING WITH ENERGY. THE SURGEON GRASPED THE BLEEDING VESSEL AT THE INFLOW SIDE, BUT THE BLOOD VOLUME INCREASED; THE PROCEDURE WAS THEN CONVERTED TO OPEN TO CONTROL THE BLEEDING VESSEL WITH SUTURES. THE SURGEON SAID THE VESSEL WAS NOT LARGER THAN 5MM AND THAT THE SYNCHROSEAL WAS WORKING FINE DURING THE WHOLE PROCEDURE. THE SURGEON SAID THE SYNCHROSEAL TONES WERE ALWAYS ACCURATE AND CONSISTENT. WHEN GRASPING THE TARGET TISSUE THE SURGEON SAID HE COULD SEE THE TIPS AND IT LOOKED LIKE A CLEAN GRASP. THE SURGEON COULD NOT CONFIRM WHETHER AN INSTRUMENT OR DEVICE MALFUNCTION OCCURRED. THE SURGEON COULD NOT GIVE AN EXACT REASON FOR HOW THE BLEEDING STARTED. THE SURGEON SAID HE ESTIMATED ABOUT 1300ML OF BLOOD LOSS, BUT THE ANESTHESIOLOGIST ESTIMATED 1800ML. THREE UNITS OF BLOOD WERE TRANSFUSED FOR THIS EVENT. PLATELETS WERE PROVIDED BECAUSE THE PATIENT HAD THROMBOCYTOPENIA. THE SURGEON REPORTED THE PATIENT IS DOING FINE AND WAS STILL HOSPITALIZED AT THE TIME OF THIS FOLLOW-UP. NO PICTURES OR VIDEOS ARE AVAILABLE OF THIS PROCEDURE. PATIENT DEMOGRAPHIC INFORMATION IS NOT AVAILABLE. THE PHYSICIAN ADDED THAT HE DID NOT LIKE HOW THE SYNCHROSEAL INSTRUMENT DOES NOT CUT AND HE HAS TO APPLY TENSION TO THE TISSUE TO SEPARATE IT. FOLLOW-UP: ON 04/22/2021, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE SURGEON TOLD THE CSR THAT THE HILUM WAS MORE CEPHALAD THAN EXPECTED AND THINKS HE GRABBED A VEIN DURING THE EVENT. THE SURGEON DID NOT SPECIFY WHAT VESSEL WAS BLEEDING. THERE WAS NO REPORT OF INSUFFICIENT SEALING DURING OR AFTER THE PROCEDURE TO THE CSR. THE PATIENT WAS GIVEN PLATELETS DUE TO THEIR THROMBOCYTOPENIA BEFORE DA VINCI PORTS WERE PLACED TO BEGIN THIS PROCEDURE. FOLLOW-UP: ON 04/23/2021, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE SURGEON TOLD THE CSR THAT HE DID NOT INTEND TO GRAB A BLOOD VESSEL DURING THE SEALING EVENT THAT CAUSED THE BLEEDING. IT IS UNKNOWN IF THE SURGEON USED THE SYNCHROSEAL ENERGY FUNCTIONS TO CONTROL THE BLEEDING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }