{ "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": "2955842-2021-10765", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20210709", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210602", "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": "20210709", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1041924", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210709", "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": "L90210210 0132", "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)230228(10)L90210210", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20210709", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20210610", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12140733", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210610", "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": "260678196", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THE CUSTOMER REPORTED THAT THIS INSTRUMENT CANNOT BE RETURNED TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE DEVICE LOGS FOR THE SYNCHROSEAL (PART# 480440-05 / LOT/SERIAL# (B)(4)) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE SYNCHROSEAL WAS LAST USED ON (B)(6) 2021 VIA SYSTEM SERIAL# (B)(4). THERE WERE 0 USES REMAINING AFTER THIS LAST USAGE. THE SYSTEM LOGS OF THIS PROCEDURE WERE REVIEWED AND THE FOLLOWING WAS OBSERVED: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. THE SYNCHROSEAL INSTRUMENT LOGS WERE REVIEWED BY A FAILURE ANALYSIS ENGINEER AND THE FOLLOWING INSIGHT WAS PROVIDED: \"I DIDN¿T FIND ANYTHING IN EITHER PROCEDURE THAT WOULD SUGGEST AN INSTRUMENT FAILURE. BOTH PROCEDURES APPEAR SIMILAR FROM THE LOGS. NO ERRORS IN THE E-100 LOGS THAT INDICATE AN INSTRUMENT FAILURE. THERE WERE SEVERAL 'HIGH INITIAL STARTING IMPEDANCE' MESSAGES RECORDED BY THE GENERATOR, WHICH INDICATES THE IMPEDANCE OF THE TISSUE BETWEEN THE JAWS WAS HIGHER THAN EXPECTED. THIS MESSAGE CAN APPEAR WHEN APPLYING ENERGY MULTIPLE TIMES OVER THE SAME AREA, OR APPLYING ENERGY ON DESICCATED/DRIED OUT TISSUE. ADDITIONALLY, A ¿COAG TIMEOUT¿ MESSAGE WAS LOGGED INDICATING THE SURGEON WAS APPLYING COAG ENERGY FOR THE LONGEST ALLOWED TIME AND THE GENERATOR AUTO-STOPPED ENERGY DELIVERY.\" THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON REPORTED THAT UNEXPECTED BLEEDING OF ABOUT 1 LITER OCCURRED DURING THE PROCEDURE FOLLOWED BY POST-OPERATIVE BLEEDING AS WELL. THE PATIENT REQUIRED A BLOOD TRANSFUSION AND WAS HOSPITALIZED AS A RESULT. IT WAS REPORTED THAT THE SYNCHROSEAL INSTRUMENT WORKED FINE AND NO ERRORS WERE GENERATED FOR THE INSTRUMENT DURING THE PROCEDURE. HOWEVER, THE SURGEON ALLEGED THAT THE UNEXPECTED BLEEDING WAS RELATED TO THE USE OF THE SYNCHROSEAL INSTRUMENT. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE." }, { "mdr_text_key": "260678197", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND REQUIRED HOSPITALIZATION IN THE ICU. THE SURGEON SAID HE NO LONGER WILL USE THE SYNCHROSEAL INSTRUMENT. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE PROCEDURE OCCURRED IN JUNE BUT THE EXACT DATE WAS NOT PROVIDED. THE PROCEDURE WAS PERFORMED ON A DA VINCI SI SYSTEM WITH AN UNKNOWN SERIAL NUMBER. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL FOUND. THE SURGEON REPORTED THAT THE SYNCHROSEAL INSTRUMENT WORKED FINE AND NO ERRORS WERE GENERATED FOR THE INSTRUMENT. THE TARGET ISSUE WAS THE PROSTATE PEDICLE. THE TARGET TISSUE WAS REPORTEDLY UNDER TENSION DURING THE SEALING AND CUTTING PROCESS. THE TARGET TISSUE WAS NOT A VESSEL GREATER THAN 5MM, HAD NO CALCIFICATION, AND NO PREVIOUS RADIATION OR CHEMOTHERAPY. THE SURGEON REPORTED THAT THEY OBSERVED TISSUE EFFECT DURING THE SEALING/SYNCH CYCLE. THE SURGEON SAID THE SYNCHROSEAL INSTRUMENT NEVER CAME INTO CONTACT WITH METAL OBJECTS SUCH AS STAPLES, SUTURES, AND CLIPS DURING THE PROCEDURE. THE JAWS OF THE SYNCHROSEAL INSTRUMENT WERE NOT IMMERSED IN A LIQUID OR CONTAMINATED BY CARBONIZED TISSUE PRIOR TO THE SEALING CYCLE. THE SURGEON REPORTED THAT UNEXPECTED BLEEDING OF ABOUT ONE LITER OCCURRED DURING THIS PROCEDURE AND THAT THEY ATTRIBUTE THE EVENT TO THE SYNCHROSEAL INSTRUMENT. THIS BLEEDING WAS REPORTEDLY RESOLVED WITH A POST-OPERATIVE TRANSFUSION. THE SURGEON REPORTED THERE WAS DELAYED BLEEDING AFTER THE PROCEDURE AS WELL. THE REPORTED POST-OPERATIVE BLEEDING WAS FIRST NOTICED DUE TO THE PATIENT¿S VITALS BECOMING UNSTABLE. THE PATIENT WAS HOSPITALIZED FOR THIS EVENT, BUT DID NOT REQUIRE AN ADDITIONAL OPERATION. THE POST-OPERATIVE BLEEDING WAS RESOLVED WITH A BLOOD TRANSFUSION AND EXPECTANT MANAGEMENT. WHEN THE SURGEON WAS ASKED WHAT THEY THINK CAUSED THE BLEEDING EVENT THE FOLLOWING ANSWER WAS PROVIDED: ¿SEALING AND THEN SUBSEQUENT VESSEL BLEED ONCE THE VESSEL CAME OUT OF SPASM.¿ THERE WERE NO PHOTOS OR VIDEOS OF THE EVENT FOR ISI TO REVIEW. THIS SYNCHROSEAL INSTRUMENT IS REPORTEDLY NOT AVAILABLE FOR RETURN." } ], "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": "" } ] }