{ "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": "2955842-2022-13941", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20220911", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220811", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "UK", "manufacturer_contact_area_code": "408", "date_added": "20220911", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220113", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1306871", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220911", "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": "480440-06", "catalog_number": "480440", "lot_number": "L90220118", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "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)240131(10)L90220118", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/07/2022;12/08/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20220911", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20220811", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15397831", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220811", "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": "299669549", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "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 WHEN THE SYNCHROSEAL INSTRUMENT IS RETURNED AND FAILURE ANALYSIS HAS COMPLETED THE INVESTIGATION. A REVIEW OF THE VIDEO CLIP OF THE INSTRUMENT FOLLOWING THE SURGICAL PROCEDURE WAS CONDUCTED BY AN ISI MANUFACTURER ENGINEER ON (B)(6) 2022. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE PIVOT PIN HAS TWO WASHERS ON EACH SIDE. IT WAS NOTED THAT THEY REMOVED THE WASHER FROM THE MACHINED HEAD OF THE PIVOT PIN AT THE START OF THE VIDEO- THAT¿S THE 30% GLASS FILLED PPA COMPONENT. IT IS THE PINK COMPONENT IN THE PICTURE. IT SEEMS THE CUSTOMER IS PURPOSELY DAMAGING THE INSTRUMENT. IF THE INSTRUMENT THEY WERE HOLDING AND ATTACKING WITH THE FORCEPS WAS THE INSTRUMENT THAT WAS USED IN THE PATIENT, THE PIVOT PIN (343308-10) IS STILL SECURED WITHIN THE INSTRUMENT JAWS- EVIDENTLY FROM THE FORCE BEING APPLIED, IT COULD NOT BE REMOVED. FROM THIS PICTURE IT DOES APPEAR THAT ONE OF THE PIVOT PIN WASHERS (344051-11) IS NOT VISIBLE. THIS IS MOST LIKELY THE MISSING COMPONENT ¿ HOWEVER AS THEY CAN BE SEEN DAMAGING THE INSTRUMENT AFTER USING IT WE CANNOT CONFIRM IF THE PIVOT PIN WASHER HAS BEEN DISLODGED INTO THE PATIENT OR IS BEING OBSCURED BY THE JAW COVER (THE JAW COVER IS A SOFT PLIABLE MATERIAL, AND CAN SOMETIMES BE PULLED OVER THE WASHER WITH MISHANDLING). UNTIL A PROCEDURE VIDEO IS PROVIDED TO WITNESS WHAT HAPPENED AROUND THE COLLISION OR THE INSTRUMENT IS RECEIVED FOR FAILURE ANALYSIS, THE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUMENT'S BATCH SEQUENCE NUMBER WAS NOT PROVIDED. THEREFORE, AN INSTRUMENT LOG REVIEW OF THE SYNCHROSEAL INSTRUMENT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT A FRAGMENT (SCREW) FELL INTO THE PATIENT DURING A PROCEDURE. TESTS WERE PERFORMED TO LOOK FOR THE FRAGMENT, BUT NOTHING WAS IDENTIFIED. AT THIS TIME, THE LOCATION OF THE FRAGMENT REMAINS UNKNOWN." }, { "mdr_text_key": "299669550", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, A SMALL RETAINING SCREW IN THE RUBBERIZED SECTION PROXIMAL TO THE SYNCHROSEAL INSTRUMENT JAW APPEARED TO BECOME DETACHED AND WAS LOST WITHIN THE PATIENT. THE CUSTOMER HAS USED X-RAY ON THE PATIENT BUT WAS UNABLE TO IDENTIFY A FOREIGN OBJECT. THE CUSTOMER HAVE ASKED INTUITIVE SURGICAL (IS) TO CONFIRM THE MATERIAL TYPE OF THE SCREW TO ADD IN ITS LOCATION AND POTENTIAL RETRIEVAL. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. ON 17-AUG-2022, ADDITIONAL INFORMATION WAS PROVIDED BY THE SPECIALTY SALES MANAGER: DURING THE SURGERY, THEY NOTICED A CIRCULAR WASHER LYING INSIDE THE PATIENT, WHICH WAS REMOVED. UPON INSPECTION OF THE SYNCHROSEAL INSTRUMENT THEY NOTICED THAT THERE IS A SMALL PIN SIZED HOLE ON THE INSTRUMENT WHICH COULD HAVE HAD A PIN INSIDE. THEY WERE NOT SURE AT THIS POINT AS TO WHETHER IT HAD A PIN INSIDE EARLIER. THEY NOTICED THAT THE OTHER SIDE HAD A PIN AND WASHER. THEY THEN TOOK OUT ANOTHER INSTRUMENT AND INSPECTED IT TO UNDERSTAND THE STRUCTURE. ONCE THEY UNDERSTOOD THAT THERE IS A MISSING PIN, THEY NEEDED TO KNOW HOW BIG IT WAS AND WHAT SHAPE THEY SHOULD SEARCH FOR WITHIN THE PATIENT. IT WAS TO UNDERSTAND THE INSTRUMENT THAT THEY WERE TRYING TO REMOVE THE WASHER AND PIN AND SEE ON THE OPPOSITE SIDE. OTHERWISE, THEY DID NOT KNOW WHAT TO LOOK FOR. THEY ASSUMED IT WOULD BE A SIMILAR PIN ON THE OTHER SIDE AND SEEING THE PIN WOULD PLACE THEM IN A BETTER POSITION TO SEARCH WITHIN THE PATIENT AND ALSO SURROUNDINGS FOR THE PIN. ON 19-AUG-2022, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SITE AND OBTAIN THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE FRAGMENT WAS RETRIEVED ROBOTICALLY. A GREY CIRCULAR DISC PROBABLY MADE OF PLASTIC WAS SEEN LYING WITHIN THE PATIENT. THEY WERE NOT SURE WHETHER THERE WERE ANY ADDITIONAL FRAGMENTS OR METALLIC PARTS INSIDE THE PATIENT, SO THEY SEARCHED INSIDE THE ABDOMEN, GAVE A THROUGH WASH, AND ALSO X-RAYED THE PATIENT TO LOOK FOR ANY METALLIC PARTS. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT THAT WAS IDENTIFIED. HOWEVER, POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS IN USE 68 MINUTES PRIOR TO THE ISSUE. INSTRUMENTS AND ACCESSORIES WERE INSPECTED PRIOR TO USE BUT NOTHING SEEMED OUT OF ORDINARY. THE FRAGMENT FELL WHILE GRASPING AND THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE AND THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. THE INSTRUMENT WAS REMOVED ONCE, DURING THE PROCEDURE (PRIOR TO THE BREAKAGE), AND THE WRIST WAS STRAIGHTENED FOR REMOVAL. ADDITIONALLY, THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA AS WELL THEY DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. NO OTHER DAMAGE WAS NOTICED TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THERE WAS NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT WITH A DELAY OF ABOUT ONE HOUR. THE TOTAL OPERATIVE TIME (LENGTH OF SURGICAL PROCEDURE) WAS 190 MINUTES CONSOLE TIME. NO VIDEOS OF THE PROCEDURE WERE AVAILABLE. HOWEVER, A VIDEO OF THE INSTRUMENT AFTER IT WAS REMOVED WAS PROVIDED FOR REVIEW." }, { "mdr_text_key": "333102534", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED COMPLAINT. THE SYNCHROSEAL WAS FOUND WITH BOTH PIVOT PIN WASHERS DISLODGED FROM THE JAW COVER. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM, PASSED THE RECOGNITION AND ENGAGEMENT TESTS, MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIPS OPENED AND CLOSED PROPERLY. UPON VISUAL INSPECTION, THE JAW CERAMIC DOTS WERE PRESENT. THE WASHERS WERE NOT RETURNED WITH THE INSTRUMENT. THE WASHERS HAVE A DIAMETER OF 0.110\". THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS ALSO OBSERVED. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE CUT ELECTRODE. THE INSTRUMENT WAS TESTED FOR ELECTRICAL CONTINUITY AND PASSED. A REVIEW OF LOGS SHOWED NO FAILURES. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE." }, { "mdr_text_key": "333581540", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "333581541", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT WAS TRANSFERRED FOR ADVANCED FAILURE ANALYSIS (FA). THE PRIMARY FA WAS CONFIRMED. IT WAS FOUND THAT BOTH WASHERS WERE DISLODGED AND MISSING FROM THE INSTRUMENT. AFTER FURTHER EXAMINING THE INSTRUMENT'S PIVOT PIN, IT WAS NOTICED THAT THE MACHINED END WAS EXTREMELY DAMAGED. THIS DAMAGE AND DEFORMATION ARE WHAT CAUSED THE WASHER TO BECOME DISLODGED ON THAT SIDE. ON THE OTHER SIDE, IT HAD BEEN DISLODGED DUE TO A DEFORMATION OF THE SWAGED SIDE OF THE PIN. BASED ON THE DAMAGES SEEN, IT IS LIKELY THAT THE CAUSE OF THE DAMAGED PINS AND, THEREFORE, THE DISLODGED WASHER IS USER RELATED. E-100 LOGS WERE ALSO CHECKED, AND NO CUTTING OR SEALING ERRORS OCCURRED, WITH THE EXCEPTION OF ONE INSTANCE OF HIGH INITIAL STARTING IMPEDANCE. THIS DID NOT AFFECT THE PERFORMANCE OF THE INSTRUMENT." } ], "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": "12/07/2022;01/06/2023" } ] }