{ "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": "2955842-2021-10775", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210709", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210518", "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": "JA", "manufacturer_contact_area_code": "408", "date_added": "20210709", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200518", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1040954", "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", "expiration_date_of_device": "20210518", "model_number": "480440-05", "catalog_number": "480440", "lot_number": "T90200518 0157", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210615", "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)220531(10)T90200518", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Separation", "Material Separation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/18/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20210709", "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": "20210616", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12145650", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210616", "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": "267700154", "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. INITIAL INSPECTION IDENTIFIED A DISLODGED PIVOT PIN WASHER. THE WASHER WAS RETURNED WITH THE INSTRUMENT AND NO PIECE WAS MISSING. THE INSTRUMENT WAS FUNCTIONALLY TESTED AND PASSED ALL TESTING SPECIFICATIONS. THE INSTRUMENT DELIVERED ENERGY WITHOUT ANY ISSUES. THE INSTRUMENT WAS FURTHER INVESTIGATED BY THE ISI FAILURE ANALYSIS ENGINEER (FAE). THE DISLODGED WASHER SHOWED SIGNS OF DAMAGE ON BOTH THE INNER AND OUTER LIPS, INDICATING A POTENTIAL FOR AN INTRAOPERATIVE COLLISION AS CAUSE FOR THE DISLODGED WASHER. NO FRAGMENTS WERE FOUND TO BE MISSING FROM THE WASHER. ADDITIONALLY, THE PIVOT PIN WAS FOUND TO BE SLIGHTLY UNDER-SWAGED, WITH THE SWAGE APPEARING SLIGHTLY LOPSIDED AND A SWAGE LIP WAS STILL VISIBLE. THE LOPSIDED SWAGE MAY HAVE ALLOWED THE WASHER TO DISLODGE EARLIER UNDER A TYPICAL MISHANDLING SCENARIO. THE EVIDENCE OF DAMAGE ON THE DISLODGED WASHER SUGGESTS A ROOT CAUSE RELATED TO USER MISHANDLING. THE INCOMPLETE SWAGE ON THE PIVOT PIN CAN BE ATTRIBUTED TO A MANUFACTURING ISSUE. A REVIEW OF THE COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THE PRODUCT. ISI RECEIVED A VIDEO CLIP OF A DA VINCI-ASSISTED SURGICAL PROCEDURE. A REVIEW OF THE VIDEO CLIP WAS CONDUCTED BY AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE). CDE IDENTIFIED A LOT OF CONTACT BETWEEN THE SYNCHROSEAL INSTRUMENT AND THE OTHER ROBOTIC INSTRUMENTS ALONG WITH THE SUCTION IRRIGATOR THAT THE ASSIST WAS USING. THE SURGEON USED THE SYNCHROSEAL INSTRUMENT TO PRESS DOWN ON TISSUE AND INADVERTENTLY SCRAPED THE WASHER ALONG THE OTHER INSTRUMENTS, WHICH ENDED UP DETACHING AND FALLING INTO THE PATIENT. THE ISSUE OCCURRED BETWEEN THE 34:00 AND 34:30 TIMESTAMPS. GENERALLY SPEAKING, THE PIVOT PIN WASHER TYPICALLY DISLODGES DUE TO USER MISHANDLING OF THE DEVICE, SUCH AS IMPROPER CLEANING AND INTRAOPERATIVE COLLISIONS. IMPROPER INSTRUMENT REMOVAL (BENT WRIST) MAY ALSO RESULT IN A DISLODGED PIVOT PIN WASHER. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING REMINDERS TO THE USER: WARNING: DO NOT USE ANY INSTRUMENT TO CLEAN THE INSTRUMENT INSIDE THE PATIENT. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. TO CLEAN AN INSTRUMENT INTRAOPERATIVELY, REMOVE THE INSTRUMENT FROM THE SYSTEM AND WIPE THE INSTRUMENT TIP WITH MOIST STERILE GAUZE. CAUTION: FAILURE TO ADHERE TO APPROVED OPERATING PRACTICES MAY RESULT IN DAMAGE TO THE INSTRUMENTS (SURGICAL AND ENDOSCOPE). EXAMPLES OF IMPROPER PRACTICES INCLUDE: DROPPING OF EQUIPMENT, COLLISIONS, AND IMPROPER CLEANING AND STERILIZATION TECHNIQUES. A DAMAGED INSTRUMENT MAY RESULT IN FRAGMENTS FALLING INTO THE PATIENT. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY THE FAE. THE IMAGE OF THE PIVOT PIN WASHER (THE ROUND PIECE CAPTURED INSIDE THE CONTAINER) ON THE SWAGED END OF THE SYNCHROSEAL WAS DISLODGED. ADDITIONALLY, IT APPEARS THERE WAS DAMAGE IN THE FORM OF A SLIGHT PUNCTURE ON THE PROXIMAL END OF THE JAW COVER. VERIFICATION THROUGH THE SYSTEM LOGS CONFIRMED A PROCEDURE PERFORMED ON (B)(6) 2021 USING (B)(4) WITH LOGGED USAGE OF A SYNCHROSEAL INSTRUMENT LOT# T90200518 / SEQUENCE 0157. THIS INSTRUMENT IS SINGLE-USE AND THEREFORE NO SUBSEQUENT USE WAS RECORDED. THE SYNCHROSEAL IS A BIPOLAR ELECTROSURGICAL INSTRUMENT FOR USE WITH A COMPATIBLE DA VINCI SURGICAL SYSTEM AND A COMPATIBLE ELECTRO SURGICAL GENERATOR. IT IS INTENDED FOR GRASPING, DISSECTION, SEALING AND TRANSECTION OF TISSUE. SYNCHROSEAL CAN BE USED TO SEAL VESSELS UP TO AND INCLUDING 5 MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. SYNCHROSEAL, WHEN USED WITH A COMPATIBLE ELECTROSURGICAL GENERATOR, CREATES A SEAL AND TRANSECTS TISSUE BY APPLICATION OF RADIOFREQUENCY (RF) ENERGY TO VESSELS AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. AN ELECTRODE SEALING SURFACE AND A CUT ELECTRODE WITHIN THE JAWS ENABLE SEALING AND CUTTING. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CDE'S ANALYSIS OF THE SUBMITTED PROCEDURE VIDEO CONFIRMS THAT THE UNINTENDED FRAGMENT FALLING INTO THE PATIENT WAS CAUSED BY MISHANDLING AND MISUSE AND FAILURE ANALYSIS CONFIRMED DAMAGE ON THE DISLODGED PIVOT PIN WASHER WITH THE ROOT CAUSE OF MISHANDLING. HOWEVER, FURTHER INVESTIGATION BY THE FAE IDENTIFIED AN INCOMPLETE SWAGE ON THE PIVOT PIN AND THE CAUSE WAS ATTRIBUTED TO A MANUFACTURING ISSUE. THIS INSTRUMENT IS DESIGNED WITH A PIVOT PIN ON THE DISTAL END ALLOWING ARTICULATION OF THE INSTRUMENT ASSEMBLIES THEY ARE HOLDING TOGETHER AND IS SECURED TO THE DEVICE BY SWAGING. IF THE PIN IS NOT PROPERLY FUSED TOGETHER, THE PIN COULD BECOME DISLODGED AND FALL INSIDE THE PATIENT. 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": "267700155", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE USER OBSERVED THAT \"THE PART THAT HOLDS THE SYNCHROSEAL INSTRUMENT JAW COVER WAS DAMAGED\" AND A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE USER NOTED THAT THE INSTRUMENT WAS NOT INVOLVED IN ANY KNOWN INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED AND REPLACED TO THE BACKUP. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND FOUND NO ISSUE. INSTRUMENT OPERATED WITH NO FUNCTIONAL ISSUE. SURGEON ALLEGES NO INCIDENT OF INSTRUMENT COLLISION. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY AN HOUR. THE FALLEN FRAGMENT WAS REMOVED THROUGH THE ASSIST PORT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. STANDARD POST-OPERATIVE TESTS WERE PERFORMED AND CONFIRMED NO RETAINED FRAGMENT." }, { "mdr_text_key": "336070211", "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": "336070212", "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": "05/24/2023" } ] }