{ "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": "2955842-2021-10544", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210521", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210423", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20210521", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200820", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "760190", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210521", "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": "T90200820 0089", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210511", "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)220831(10)T90200820", "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": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/15/2021;04/23/2021", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "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": "20210521", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210423", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11863502", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210423", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "267747549", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT \"THE SYNCHROSEAL INSTRUMENT JAW HINGE PIN END PIECE FELL OFF THE INSTRUMENT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THE DISLODGED PIVOT PIN WASHER TO BE RELATED TO THE CUSTOMER'S REPORTED COMPLAINT. FOR CLARIFICATION, THE PIN WAS NOT DISLODGED/REMOVED FROM THE INSTRUMENT, BUT RATHER THE PIVOT PIN WASHER. A VISUAL INSPECTION WAS PERFORMED AND THE INSTRUMENT WAS FOUND TO HAVE A PIVOT PIN WASHER DISLODGED. THE PIVOT PIN WASHER WAS RETURNED WITH THE INSTRUMENT. NO DAMAGE TO THE PIVOT PIN WAS OBSERVED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAWS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED JAW CERAMIC DOT VERIFICATION AND CERAMIC DOT SWIPE TESTS. THIS RMA WAS TRANSFERRED TO ENGINEERING FOR FURTHER REVIEW. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: BASED ON A LOG REVIEW OF ENGAGEMENT LOGS, THE INSTRUMENT WAS FOUND TO HAVE ENGAGEMENT FAILURES. HOWEVER, THE FAILURES WERE NOT REPLICATED DURING IN-HOUSE TESTING. THE ROOT CAUSE OF THIS FAILURE IS NOT DETERMINABLE. THIS INSTRUMENT WAS TRANSFERRED TO ENGINEERING FOR FURTHER INVESTIGATION: ENGINEERING CONFIRMED THE ABOVE FINDINGS. THE PIVOT PIN WASHER WAS DISLODGED FROM THE PIVOT PIN AND WAS RETURNED WITH THE INSTRUMENT. THE PIVOT PIN WAS INSPECTED AND FOUND TO BE SWAGED. NO DAMAGE TO THE JAW COVER OR PIVOT PIN WAS FOUND. THE PIVOT PIN WAS SECURE IN THE JAW OF THE INSTRUMENT, INDICATING THAT IT WAS THE PIVOT PIN WASHER THAT HAD FALLEN INTO THE PATIENT AND NOT THE PIN. THIS EVIDENCE SUGGESTS THE DISLODGED WASHER HAS A POTENTIAL ROOT CAUSE RELATED TO USER MISHANDLING, SUCH AS COLLISIONS/IMPROPER REMOVAL/IMPROPER CLEANING/ETC. FURTHER INSPECTION OF THE PIVOT PIN ITSELF FOUND THE SWAGE ON THE PIVOT PIN TO BE INCOMPLETE OR PARTIAL. DURING TESTING, THE PIVOT PIN COULD NOT BE REMOVED FROM THE INSTRUMENT WITHOUT SIGNIFICANT FORCE AND USE OF TOOLS. THE PIVOT PIN ITSELF WAS UNLIKELY TO DISLODGE WITHIN THE PATIENT. THIS SECONDARY FINDING (INCOMPLETE/PARTIAL PIVOT PIN SWAGE) IS DUE TO WORKMANSHIP. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: SYSTEM SERIAL #, DEVICE MATERIAL, LOT#/SERIAL #, AND EVENT DATE. THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM (B)(4). FOR 00:22:39. THE SYNCHROSEAL HAS 0 USES REMAINING AFTER THE LAST USE AS THE INSTRUMENT IS A SINGLE-USE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE SYNCHROSEAL INSTRUMENT JAW HINGE PIN END PIECE FELL OFF THE INSTRUMENT INTO THE PATIENT. IT IS UNKNOWN WHAT CAUSED THE PIVOT PIN WASHER TO FALL INSIDE THE PATIENT, BUT IT IS POSSIBLE THAT THE IMPROPER SWAGING OF THE PIVOT PIN MAY HAVE BEEN A CONTRIBUTING FACTOR. ALTHOUGH, THE PIVOT PIN WASHER WAS RETRIEVED DURING THE SAME PROCEDURE, AND NO ADVERSE OUTCOME OR INJURY WAS REPORTED, IF THE FAILURE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "267747550", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE THE SYNCHROSEAL INSTRUMENT JAW HINGE PIN, END PIECE, FELL OFF THE INSTRUMENT INTO THE PATIENT. THE SURGEON RETRIEVED THE PIECE WITH A BACKUP INSTRUMENT AND CONTINUED THE PROCEDURE. NO OTHER PIECES WERE OBSERVED TO BE MISSING FROM THE INSTRUMENT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CALLER TO PROMPT THE CUSTOMER TO RETURN THE INSTRUMENT FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "327082743", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN IMAGE OF THE SYNCHROSEAL INSTRUMENT WAS RECEIVED FROM THE CUSTOMER. A REVIEW OF THE PROVIDED IMAGE WAS CONSISTENT WITH THE REPORT OF THE HINGE PIN END PIECE FALLING OFF THE INSTRUMENT. FURTHER DETAILS REGARDING THE FAILURE MODE WERE OBTAINED THROUGH THE FAILURE ANALYSIS INVESTIGATION THAT WAS OBTAINED UPON THE RETURN OF THE INSTRUMENT." }, { "mdr_text_key": "327082744", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335839946", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335839947", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\" B2 UPDATED TO \"REQUIRED INTERVENTION\" H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/22/2021;05/24/2023" } ] }