{ "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": "2955842-2022-10187", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20220206", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220111", "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": "NIELSON", "source_type": [ "Other", "Foreign", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20220206", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211104", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1497099", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220206", "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": "L91211109 0047", "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)231130(10)L91211109", "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": "04/26/2022;06/21/2022;01/12/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20220206", "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": "20220112", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13467272", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220112", "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": "288187008", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOIDECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS BROKEN AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON JANUARY 20, 2022 INTUITIVE SURGICAL (IS) CONTACTED THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE FIRST ASSISTANT REMOVED THE FRAGMENT WITH A LAPAROSCOPIC INSTRUMENT. THE SURGICAL STAFF DOUBLE CHECKED THE PATIENT'S ANATOMY THEY WERE WORKING ON TO CONFIRM THAT NO FRAGMENT REMAINED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. IT WAS NOT NECESSARY TO PERFORM POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRA SOUND TO CHECK FOR REMAINING FRAGMENTS. AS PER THE SURGEON, THE CAUSE OF THE INSTRUMENT BREAKAGE IS UNKNOWN. THE INSTRUMENT WAS IN USE DURING THE WHOLE THE PROCEDURE. THE INSTRUMENT WAS INSPECTED BY THE NURSE BEFORE THEY HANDED IT TO THE SURGEON. NO DAMAGE WAS NOTICED. NO ISSUE OF THE INSTRUMENT FUNCTIONALITY NOTICED DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF INDICATED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER ONE DURING PROCEDURE. THE INSTRUMENT WAS REMOVED WITH NO RESISTANCE DURING THE PROCEDURE. THE WRIST WAS STRAIGHTENED PRIOR TO REMOVAL. NO DAMAGE WAS NOTICED ON THE CANNULA OR OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THERE WAS NO ADVERSE EFFECT OR INJURY TO THE PATIENT. THE PATIENT HAS NOT PRESENTED WITH ANY POST-OPERATIVE COMPLICATIONS. THE INSTRUMENT WILL BE RETURNED FOR EVALUATION." }, { "mdr_text_key": "288187009", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN RMA HAS BEEN ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INSTRUMENT RETURNED; HOWEVER, ISI HAS NOT YET 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 ADDITIONAL INFORMATION IS OBTAINED. PRODUCT AND EVENT VERIFICATION: A REVIEW OF THE DEVICE LOGS FOR THE SYNCHROSEAL (PART# 480440-05 / LOT/SERIAL# (B)(4)) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE SYNCHROSEAL INSTRUMENT WAS LAST USED ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). THERE WERE 0 USES REMAINING AFTER THIS LAST USAGE. THIS DEVICE IS A SINGLE-USE INSTRUMENT AND THEREFORE ONLY HAS ONE USE ALLOTTED TO IT. THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S ONLY ALLOTTED USAGE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A PHOTOGRAPHIC IMAGE WAS PROVIDED AND IS IN REVIEW AS OF THE DATE OF THIS INITIAL REPORT. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY. AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. 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 AS UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION." }, { "mdr_text_key": "329810147", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D9, G3, G6, H2, AND H3.ANALYSIS INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. BOTH INSTRUMENT PIVOT PIN WASHERS WERE NO LONGER ATTACHED TO THE JAW COVER AT THE WRIST ASSEMBLY. ONE PIVOT PIN WASHER WAS RETURNED BY THE CUSTOMER. THE 2ND PIVOT PIN WASHER WAS NOT RETURNED. MATERIAL APPROXIMATELY 0.11\" X 0.11\" WAS MISSING AND NOT RETURNED BY THE CUSTOMER. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A DISLODGED WASHER TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE ROOT CAUSE IS ATTRIBUTED TO MISHANDLING/MISUSE." }, { "mdr_text_key": "329810148", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "331684177", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS INSTRUMENT WAS TRANSFERRED TO ENGINEERING FOR FURTHER EVALUATION. THE PRIMARY FAILURE ANALYSIS RESULT WAS CONFIRMED. AFTER MICROSCOPIC ANALYSIS, IT WAS DETERMINED THAT THE SWAGE ON THE PIVOT PIN WAS INSUFFICIENT, LEADING TO THE DISLODGED WASHER." }, { "mdr_text_key": "331684178", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336796576", "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": "336796577", "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": "05/27/2022;07/22/2022;05/24/2023" } ] }