{ "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": "2955842-2021-10518", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210517", "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": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20210517", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200813", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "734551", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210517", "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": "L90200818-0262", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210622", "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)L90200818", "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": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2021;05/07/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "health_professional": "", "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": "20210517", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "71 YR", "patient_sex": "Female", "patient_weight": "60 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210512", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11830773", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210512", "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": "267900186", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SYNCHROSEAL INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE INSTRUMENT LOG FOR THE SYNCHROSEAL INSTRUMENT (PART # 480440-05/LOT #L90200818 0262) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS USED ON (B)(6) 2021, ON SYSTEM (B)(4). THIS IS A SINGLE-USE INSTRUMENT. IN ADDITION, A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THE INSTRUMENT AND OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE SURGEON REPORTEDLY FOUND A PIECE FROM THE SYNCHROSEAL INSTRUMENT INSIDE THE PATIENT'S ANATOMY. IT WAS UNKNOWN AT WHAT POINT THE PIECE FELL. THE PIECE WAS RETRIEVED, AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE PIECE TO FALL FROM THE INSTRUMENT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR." }, { "mdr_text_key": "267900187", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS FOUND TO HAVE THE BUTTON FELL OFF. THE BUTTON WAS IN A CUP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE BUTTON SIMPLY FELL OFF AND WAS DISCOVERED WITHIN THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE FRAGMENT WAS LIKELY RETRIEVED WITH A ROBOTIC/LAP INSTRUMENT DURING THE CASE. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT NOR ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE WRIST WAS NOT STRAIGHTENED PRIOR TO REMOVAL BUT WAS STRAIGHTENED UPON FINAL REMOVAL OF THE INSTRUMENT. NO PATIENT INJURY WAS IDENTIFIED. THE PART L90200818-0262 WAS USED ON (B)(6) 2021." }, { "mdr_text_key": "325591930", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D11-INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. VISUAL INSPECTION WAS PERFORMED, AND THE INSTRUMENT WAS FOUND TO HAVE THE DISTAL WASHER DISLODGED. THE DISTAL WASHER WAS RETURNED WITH THE INSTRUMENT. NO DAMAGE TO THE DISTAL PIN OR THE DISTAL WASHER WAS OBSERVED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH 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. NO FAILURES FOUND DURING LOG REVIEW. THIS RMA WAS TRANSFERRED TO ENGINEERING FOR FURTHER REVIEW. UNDER MAGNIFICATION, IT WAS DISCOVERED THAT THERE WAS A SMALL CHUNK OF THE JAW COVER MISSING. THE DAMAGE TO THE PIVOT PIN AND JAW COVER WERE IN LINE. THE PIVOT PIN WAS INSPECTED AND WAS FOUND TO BE FULLY SWAGED. THIS EVIDENCE SUGGESTED THE PIVOT PIN WASHER DISLODGED DUE TO A COLLISION (MISHANDLING/MISUSE). ISI RECEIVED USER FACILITY REPORT # (B)(4) ON (B)(6) 2021 STATING: \"THE ROBOTIC SYNCHROSEAL DEVICE WAS USED DURING A ROBOTIC HYSTERECTOMY AND BILATERAL SALPINGO -OOPHORECTOMY (BSO) AND SENTINEL PELVIC LYMPH NODE BIOPSIES PROCEDURE. DURING THE CASE, THE TEAM NOTED THAT A SMALL PLASTIC PIECE HAD CAME OFF NEAR THE DEVICE HINGE AND FLOATED BY THE CORNER OF THE SCREEN INTO THE PATIENT. IT WAS NOTED AS BEING QUITE SMALL (APPROXIMATELY 2.5MM) AND HAS THE APPEARANCE OF A DONUT-SHAPED WASHER. THE TEAM WAS ABLE TO REMOVE IT AND HE DEVICE WAS NO LONGER USED FOR THE PROCEDURE. IN ASSESSING A DIFFERENT, NEW DEVICE, THE DEFECT COULD BE RECREATED. THE OBJECT IS SMALL ENOUGH THAT IT MAY BE DIFFICULT TO FIND IN A LARGE PATIENT. DETACHMENT MAY ALSO NOT BE NOTICED BY THE USER SINCE THE DEVICE CAN APPEAR TO OPERATE NORMALLY DESPITE THE WASHER BEING REMOVED. THE USER MAY ALSO NOT SEE THE DEVICE DETACH. IT IS ALSO UNCLEAR WHETHER THIS PIECE SERVES TO INSULATE THE METAL UNDERNEATH TO PREVENT ARCING AND DAMAGE TO OTHER TISSUE.\"." }, { "mdr_text_key": "335839548", "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." }, { "mdr_text_key": "335839549", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/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": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/14/2021;05/24/2023" } ] }