{ "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": "2955842-2021-10726", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210630", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210527", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20210630", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200826", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "991476", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210630", "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": "T90200826-0023", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210811", "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)T90200826", "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", "Device Dislodged or Dislocated", "Detachment of Device or Device Component", "Device Dislodged or Dislocated" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/13/2021;06/01/2021", "mfr_report_type": "", "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": "20210630", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210601", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12090802", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210601", "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": "267742978", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SYCHROSEAL INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. A REVIEW OF THE INSTRUMENT LOG FOR THE SYCHROSEAL PART#480440-05/ T90200826 0023 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM SK2115 . THERE WERE 0 LIVES REMAINING. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. THE PROVIDED IMAGES WERE REVIEWED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE) AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: \"THE PIVOT PIN WASHER ON THE SYNCHROSEAL APPEARED TO HAVE BEEN DISLODGED AND RECOVERED INSIDE THE CUP. GENERALLY SPEAKING, THE PIVOT PIN WASHER TYPICALLY DISLODGES DUE TO 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.\" FAE RECOMMENDED THE INSTRUMENT BE RETURNED SO FAILURE ANALYSIS CAN INSPECT THE INSTRUMENT FOR ANY DAMAGE AND CONFIRM THE FAILURE MODE. ADDITIONALLY, IF THE SITE HAS ANY PROCEDURE VIDEO AVAILABLE FOR REVIEW, THAT MAY PROVE USEFUL TO THE INVESTIGATION. THIS COMPLAINT IS DEEMED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A SMALL DISC OF THE SYNCHROSEAL INSTRUMENT REPORTEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED WITH NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. HOWEVER, UNINTENDED ITEMS FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE SMALL DISC TO FALL INTO THE PATIENT. ALTHOUGH THERE WAS NO PATIENT INJURY REPORTED, IF THE EVENT WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. IF ADDITIONAL INFORMATION RELATED TO THIS COMPLAINT IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "267742979", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, A SMALL DISC FELL OFF OF THE SYNCHROSEAL INSTRUMENT AND INTO THE ABDOMEN OF THE PATIENT. THE SMALL DISC WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON (B)(6) 2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED VIA ROBOTIC INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND WAS UNSURE OF THE CAUSE OF THE ISSUE. THE FOLLOWING WAS INFORMATION WAS REQUESTED, BUT WAS UNKNOWN: WHAT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE ISSUE, HOW LONG THE INSTRUMENT HAD BEEN IN USE AT THE TIME OF THE ISSUE, IF THERE WERE ANY COLLISIONS, IF THE INSTRUMENT WAS REMOVED THROUGH THE CANNULA PRIOR TO THE ISSUE, AND IF THERE WAS ANY OTHER DAMAGE TO THE INSTRUMENT OR THE CANNULA ONCE THE INSTRUMENT HAD BEEN REMOVED. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI. THERE ARE PHOTOGRAPHIC IMAGES AVAILABLE OF THE INSTRUMENT AND THE FRAGMENT. PATIENT-RELATED INFORMATION WAS NOT AVAILABLE." }, { "mdr_text_key": "336868531", "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, B2, AND H1: B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO \"REQUIRED INTERVENTION\". H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." }, { "mdr_text_key": "336868532", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "326077915", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REFER TO THE FOLLOWING FIELD FOR CORRECTED INFORMATION: D4 (LOT NUMBER) REFER TO THE FOLLOWING FIELDS FOR DEVICE EVALUATION INFORMATION: H6 AND H10 REFER TO THE FOLLOWING FIELDS FOR UPDATED INFORMATION: D9, G3, H2, AND H3 D03, D11 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) CONFIRMED THE REPORTED ISSUE AS THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED PIVOT PIN WASHER. THE WASHER MEASURED APPROXIMATELY 0.110\" IN DIAMETER AND WAS RETURNED ALONG WITH THE INSTRUMENT. FA NOTED THE WASHER AND PIVOT PIN DID NOT EXHIBIT ANY MECHANICAL DAMAGE. FA ATTRIBUTED THE ROOT CAUSE OF THE ISSUE TO MISHANDLING/MISUSE. THE INSTRUMENT WAS TESTED AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS AND THE GRIPS OPENED/CLOSED PROPERLY. ALSO, ALL 9 JAW CERAMIC DOTS WERE PRESENT AT THE TIPS AND THE INSTRUMENT PASSED ENERGY DELIVERY TESTS WITHOUT ISSUE. THE INSTRUMENT LOGS WERE REVIEWED AND SHOWED NO FAILURES. ADDITIONALLY, FA NOTED OBSERVATIONS THAT WERE NOT REPORTED BY THE SITE: THE INSTRUMENT HAD A TEAR/GOUGE ON THE DISTAL JAW COVER, WHICH MEASURED APPROXIMATELY 0.015\" IN LENGTH. THERE WAS NO MATERIAL MISSING AND FA ATTRIBUTED THE FAILURE TO THE MISHANDLING/MISUSE. ADVANCED FA (AFA) CONFIRMED THE INITIAL FA OF THE INSTRUMENT. THERE WERE LIGHT INDENTATIONS ON THE OUTER FACE OF THE WASHER, A TEAR IN THE JAW COVER NEAR THE OUTER DIAMETER OF THE ORIGINAL LOCATION OF THE WASHER, AND A SLIGHT DENT ON THE OUTER LIP OF THE PIVOT PIN WHICH SUGGESTED THAT THE WASHER WAS DISLODGED PRIMARILY BY COLLISION/USER MISHANDLING. AFA ALSO FOUND THE SWAGE OF THE PIVOT PIN TO BE SLIGHTLY LOPSIDED. THE LOPSIDED SWAGE MAY HAVE ALLOWED THE WASHER TO DISLODGE FROM THE PIVOT PIN WITH LESS FORCE DURING A COLLISION. THE PIVOT PIN WAS SECURE WITHIN THE INSTRUMENT JAWS. THE SLIGHTLY LOPSIDED SWAGING WAS ATTRIBUTED TO MANUFACTURING." }, { "mdr_text_key": "326077916", "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": "09/07/2021;05/24/2023" } ] }