{ "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": "2955842-2021-10347", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210402", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210305", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "", "date_added": "20210402", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "506274", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210402", "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": "T90200626 0056", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210406", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)220630(10)T90200626", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Thermal Decomposition of Device", "Arcing", "Insufficient Device Problem Information", "Thermal Decomposition of Device", "Arcing", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/12/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20210402", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hematoma" ] } ], "distributor_city": "", "date_report": "20210305", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11610648", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210305", "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": "323284551", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "323284552", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D02 - INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SYNCHROSEAL INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THERMAL DAMAGE TO THE CUT ELECTRODE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE TO THE CUT ELECTRODE. ROOT CAUSE OF THIS FAILURE WAS ATTRIBUTED TO MISHANDLING. A REVIEW OF THE LOGS SHOWED NO ERRORS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED INITIALIZATION. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY AND ENERGY DELIVERY TESTS. THE INSTRUMENT WAS TRANSFERRED TO ENGINEERING FOR FURTHER INVESTIGATION. THE INSTRUMENT'S CUT ELECTRODE APPEARS TO BE THERMALLY DAMAGED. THERMAL DAMAGE IS DUE TO ARCING EVENTS, WHICH ARE A BYPRODUCT OF THE BIPOLAR CUT FUNCTION AND ARE DEPENDENT ON FACTORS SUCH AS AMOUNT OF TISSUE GRABBED, TYPE OF TISSUE, AMOUNT OF NEARBY FLUID, ETC. FOR CLARIFICATION, THIS FAILURE IS A COMPONENT FAILURE AND IS NOT DUE TO MISHANDLING. ADDITIONALLY, THE CORRESPONDING BURN MARKS ON THE SEAL ELECTRODE INDICATE THAT THE ARC REMAINED BETWEEN THE INSTRUMENT JAWS. E-100 ENERGY LOGS WERE NOT AVAILABLE FOR THIS PROCEDURE. ADDITIONALLY, THE INSTRUMENT PASSED THE GRIP FORCE TEST WITH 4.71 LBS FORCE IN THE STRAIGHT ORIENTATION. THE THERMAL DAMAGE FOUND ON THE CUT ELECTRODE DOES NOT AFFECT INSTRUMENT SEALING PERFORMANCE. THE INSTRUMENT PASSED ALL SEALING RELATED FUNCTIONAL TESTS." }, { "mdr_text_key": "243720458", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SYNCHROSEAL INSTRUMENT ASSOCIATED WITH THIS COMPLAINT. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS SYSTEM WAS NOT CONNECTED TO ONSITE, SO THE E-100 ENERGY EVENTS WERE NOT RECORDED. THE SYSTEM LOGS FOR THE PROCEDURE (REVIEWED BY TECHNICAL SUPPORT), CONFIRMED THAT NONE OF THE MESSAGES STORED ARE APPLICABLE TO THE COMPLAINT. THE PROVIDED INSTRUMENT IMAGES WERE REVIEWED BY A FAILURE ANALYSIS ENGINEER AND THE FINDINGS WERE AS FOLLOWS: THE INSTRUMENT APPEARS TO HAVE THERMAL DAMAGE ON THE CUT ELECTRODE. BOTH THE MESSAGE AND THE THERMAL DAMAGE ARE THE RESULT OF ONE OR MORE ARCING EVENTS. THE ERROR MESSAGES INDICATE THE GENERATOR¿S ARC DETECTION WAS TRIGGERED. ARCS (THAT REMAIN BETWEEN THE JAWS OF THE INSTRUMENT) ARE AN EXPECTED CONDITION OF BIPOLAR CUT/SYNC DEPENDING ON FACTORS SUCH AS AMOUNT OF TISSUE GRABBED, AMOUNT OF FLUID PRESENT, TISSUE TYPE, ETC. IN THIS CASE THERE ARE LIKELY EVENTS RELATED TO ARCING (CUT ELECTRODE SHORTED) STORED WITHIN THE E-100¿S PROCEDURE LOGS, ACCESSIBLE IF THE SYSTEM WAS CONNECTED TO ONSITE. HOWEVER, IN THIS COMPLAINT THERE WAS NO ALLEGATION OF ARCING. IT WAS AN OBSERVATION OF DAMAGE AND ERROR MESSAGES RELATED TO ARCING. SO, MOST LIKELY, THE ARCS REMAINED INSIDE THE JAWS AS INTENDED. THE INSTRUCTIONS FOR USE MANUAL PROVIDES THE FOLLOWING WARNINGS: CAUTION: USE CAUTION WHEN RELEASING TISSUE FROM THE JAWS OF THE INSTRUMENT AFTER APPLYING SYNC ENERGY WITH THE YELLOW PEDAL IF THE AUDIO TONE FROM THE GENERATOR INDICATES UNSUCCESSFUL COMPLETION OF THE SEALING CYCLE (I.E. ERROR TONE). INCOMPLETE SEALING CYCLE¿E-100 IF THE E-100 DETECTS AN INCOMPLETE SEAL, IT STOPS APPLYING ENERGY, SOUNDS AN AUDIBLE ERROR TONE , AND DISPLAYS A MESSAGE ON THE SURGEON CONSOLE 3D VIEWER AND TOUCHSCREEN. ¿INSPECT JAWS FOR POSSIBLE DAMAGE INCOMPLETE ACTIVATION CYCLE.¿ INCOMPLETE SEALING MAY OCCUR DUE TO THE FOLLOWING: POSSIBLE JAW DAMAGE IF THE GENERATOR DETECTS AN ARC DURING ENERGY ACTIVATION, IT STOPS APPLYING ENERGY, PRODUCES AN ERROR TONE, AND INDICATES AN INCOMPLETE ACTIVATION CYCLE (FIGURE 3.4). INSPECT THE INSTRUMENT JAWS FOR POSSIBLE DAMAGE BEFORE REAPPLYING ENERGY. INTERFERING MATERIAL IF THE GENERATOR DETECTS INTERFERING MATERIAL (SUCH AS EXCESS FLUID, METAL STAPLES, OR METAL CLIPS) IN THE JAWS DURING ENERGY ACTIVATION, IT STOPS APPLYING ENERGY, PRODUCES AN ERROR TONE, AND INDICATES AN INCOMPLETE SEAL CYCLE. REMOVE ANY INTERFERING MATERIAL FROM THE SEAL AREA BEFORE REAPPLYING ENERGY. WARNING: IF THE JAWS ARE CONTAMINATED BY CARBONIZED TISSUE PRIOR TO SEALING, INSUFFICIENT SEALING AND TISSUE STICKING CAN OCCUR. ENSURE THAT THE JAWS ARE CLEAN DURING USE. IN THIS EVENT, THE SITE HAD CONFIRMED THAT THERE WAS CARBONIZED TISSUE IN THE JAWS. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS AN ISSUE WITH THE SYNCHROSEAL INSTRUMENT. IT WAS ALLEGED THAT AS A RESULT, A HEMATOMA WAS OBSERVED AT THE END OF THE VAGINA WHICH RESULTED IN A PROLONGED HOSPITALIZATION. HOWEVER, THE SITE HAD CONFIRMED THAT THERE WAS CARBONIZED TISSUE IN THE JAWS. AS PER THE IFU WARNING, IF THE JAWS ARE CONTAMINATED BY CARBONIZED TISSUE PRIOR TO SEALING, INSUFFICIENT SEALING AND TISSUE STICKING CAN OCCUR. ENSURE THAT THE JAWS ARE CLEAN DURING USE. IT IS UNKNOWN IF ANY FRAGMENT FELL INSIDE THE PATIENT SECONDARY TO THE WHITE PADS MELTING, AND IF ANY FRAGMENT WAS RETAINED INSIDE THE PATIENT." }, { "mdr_text_key": "243720459", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS AN ISSUE WITH THE SYNCHROSEAL INSTRUMENT. WHEN THE SURGEON WAS TRYING TO SEAL, THERE WAS AN ERROR MESSAGE STATING, \"INSPECT JAWS FOR POSSIBLE DAMAGE. HEMOSTASIS MAY BE COMPROMISED.¿ THE JAWS WERE QUITE DIRTY, SO THEY CLEANED AND REINSTALLED THE INSTRUMENT. THE SURGEON ACTIVATED THE SYNC MODE TWICE, BUT THE SAME MESSAGE WAS DISPLAYED AGAIN. THE SURGEON PULLED THE INSTRUMENT, CHECKED THE TIP, AND FOUND THAT PART OF THE WHITE PAD WAS MELTED OR MISSING. AS A RESULT, THE SURGEON STOPPED USING THE INSTRUMENT. INFORMATION ON PATIENT DEMOGRAPHICS AND RELATED PATIENT INFORMATION (RELEVANT TESTS AND RELEVANT PATIENT HISTORY INCLUDING PRE-EXISTING MEDICAL CONDITIONS) WAS REQUESTED; HOWEVER, THE SITE INDICATED THAT PATIENT-RELATED INFORMATION COULD NOT BE PROVIDED/RELEASED. IT WAS NOTED THAT A HEMATOMA WAS OBSERVED AT THE END OF THE VAGINA; AS A RESULT, HOSPITALIZATION WAS PROLONGED. THE SURGEON STATED, \"THERE IS A POSSIBILITY OF INADEQUATE SEALING\". INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AT THE TIME OF THE REPORTED ISSUE, THE SURGEON WAS ATTEMPTING TO TRANSECT AN UNSPECIFIED LIGAMENT AND VESSEL. THERE WAS NO REPORTED BLEEDING OR INJURY TO THE UNSPECIFIED VESSEL AND LIGAMENT. PRIOR THE REPORTED ISSUE, THE SYNCHROSEAL INSTRUMENT WAS WORKING FOR ABOUT 32 MINUTES WITHOUT ANY REPORTED ISSUES.\" THE FOLLOWING ARE UNKNOWN: IF THERE WAS ANY ARCING WITNESSED, IF THE VESSEL WAS GREATER THAN 5 MM, TISSUE EXPOSED TO ANY RADIATION OR CHEMOTHERAPY, AND IF THE JAWS COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS. IT WAS CONFIRMED THAT JAWS WERE CONTAMINATED WITH CARBONIZED TISSUE, THERE WAS NO BLEEDING EXPERIENCED, NO TISSUE TENSION, NO CALCIFICATION, AND THERE WAS NO TISSUE EFFECT SEEN. THERE IS NO ALLEGATION THAT A FRAGMENT FELL INSIDE THE PATIENT. HOWEVER, IT IS UNKNOWN IF ANY FRAGMENTS FELL INSIDE, SECONDARY TO THE WHITE PADS MELTING." } ], "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": "05/07/2021" } ] }