{ "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": "2955842-2021-11782", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20211220", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20211126", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20211220", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210715", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1943350", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211220", "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": "L90210718 0049", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20211228", "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)230731(10)L90210718", "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": "12/30/2021;11/26/2021", "mfr_report_type": "Follow-Up", "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": "20211220", "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": "20211126", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13048468", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211126", "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": "327714233", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "327714234", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D11, D03 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. INSPECTION FOUND A DISLODGED PIVOT PIN WASHER. THE WASHER MEASURING APPROXIMATELY 0.110\" IN DIAMETER WAS RETURNED. FURTHER INSPECTION IDENTIFIED A TORN JAW COVER. VARIOUS TEARS AND PUNCTURES MEASURING APPROXIMATELY 0.010\" TO 0.075\" IN LENGTH WERE OBSERVED ALL THROUGHOUT THE ENTIRE JAW COVER AT THE DISTAL WRIST, INCLUDING THE PIVOT PIN HOLE WITH THE DISLODGED WASHER. NO MISSING MATERIAL WAS OBSERVED. THE KNOWN CAUSE OF THESE ISSUES IS ATTRIBUTED TO MISHANDLING AND MISUSE. THE INSTRUMENT WAS PLACED AND DRIVEN IN AN IN-HOUSE SYSTEM AND PASSED ALL TESTING SPECIFICATION INCLUDING VERIFICATION FOR ENERGY DELIVERY. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT WAS FURTHER INVESTIGATED AND RESULTS CONFIRMED THE PIVOT PIN SWAGE TO BE INSUFFICIENT. THIS CONDITION MAY HAVE ALLOWED THE WASHER TO DISLODGE FROM THE INSTRUMENT PIVOT PIN WITH LESS FORCE. THE PIVOT PIN WAS SECURED WITHIN THE INSTRUMENT JAWS. THE ADDITIONAL FINDING WAS INDICATED TO BE MANUFACTURING RELATED." }, { "mdr_text_key": "335846112", "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": "335846113", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "286937155", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE SYNCHROSEAL INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TO BE PERFORMED, BUT THE INSTRUMENT HAS NOT YET BEEN RECEIVED. 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 SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE IMAGE OF THE SYNCHROSEAL INSTRUMENT IDENTIFIES A DISLODGED DISTAL PIVOT PIN WASHER. THIS IS LIKELY DUE TO COLLISION INDICATIVE OF INSTRUMENT MISHANDLING AND MISUSE; HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE BASED ON THIS ANALYSIS. A REVIEW OF THE LOGS FOR SYSTEM (B)(4) WITH A PROCEDURE DATE OF (B)(6) 2021 CONFIRMS THE SYNCHROSEAL INSTRUMENT LOT # L90210718-0049 WAS USED DURING A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE. THIS IS A SINGLE USE INSTRUMENT. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT A PIECE OF THE INSTRUMENT FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING/MISUSE. THE FALLEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY. AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE PIECE TO BECOME DISLODGED 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": "286937156", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, A PIECE OF THE SYNCHROSEAL INSTRUMENT BROKE DURING INTRAOPERATIVE USE. THE BROKEN FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT JAWS DID NOT COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS. THE USER CONTINUED WITH THE PROCEDURE USING A THIRD PARTY INSTRUMENT WITH NO FURTHER ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED." } ], "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": "01/25/2022;05/24/2023" } ] }