{ "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": "2955842-2022-12127", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220611", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220414", "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_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20220612", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210701", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2812642", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220611", "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": "L90210706 0183", "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)230731(10)L90210706", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/04/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20220611", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "59 YR", "patient_sex": "Male", "patient_weight": "75 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220512", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14671759", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220512", "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": "294887007", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE WHEEL HOLDING THE SHEATH OF THE SYNCHROSEAL INSTRUMENT CAME OFF AND FELL INTO THE PATIENT WHEN THE INSTRUMENT TOUCHED THE ENDOSCOPE. THE FRAGMENT WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 19-MAY-2022: THE BROKEN WHEEL FELL ON THE DIGESTIVE TRACT AND WAS RETRIEVED WITH A LAPAROSCOPIC SURGICAL FORCEPS. IT WAS CONFIRMED THAT THE ENTIRE WHEEL WAS RETRIEVED AND NO ADDITIONAL POSTOPERATIVE TESTS WERE PERFORMED TO REMOVE IT. THE SURGEON BELIEVED THAT HE MIGHT HAVE HIT THE ENDOSCOPE WITH THE SYNCHROSEAL INSTRUMENT JUST BEFORE THE WHEEL WAS SEEN ON THE DIGESTIVE TRACT. THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR APPROXIMATELY 3 HOURS PRIOR TO ISSUE OCCURRED AND THE SURGEON WAS PERFORMING A HEPATECTOMY: SECTION OF THE LIVER. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY AND THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THERE WAS A PROCEDURE DELAY OF ABOUT 15 MINUTES TO RECOVER THE ITEM, AND AN ADDITIONAL 20 MINUTES BECAUSE THE PROCEDURE WAS SLOWED DOWN AT THE END OF THE OPERATION WITHOUT THE SYNCHROSEAL." }, { "mdr_text_key": "294887008", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE 8MM SYNCHROSEAL INSTRUMENT BE RETURNED FOR EVALUATION, HOWEVER IT 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 INSTRUMENT LOG FOR THE SYNCHROSEAL (480440-05/LOT NUMBER L90210706 0183) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE SYNCHROSEAL INSTRUMENT WAS LAST USED IN A PROCEDURE ON (B)(6) 2022 VIA SYSTEM SK0183. THE ALLEGED INSTRUMENT HAD 0 USE REMAINING AFTER THE LAST PROCEDURAL USE. AN EVENT VERIFICATION CONFIRMED THE PROCEDURE WAS PERFORMED ON THE REPORTED EVENT DATE (B)(6) 2022 ON SYSTEM SK0183. NO IMAGE OF THE PROCEDURE WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION AND ADVERSE EVENT DUE TO THE FOLLOWING CONCLUSION: THE WHEEL HOLDING THE SHEATH OF THE SYNCHROSEAL CAME OFF AND FELL INTO THE PATIENT DURING PROCEDURE. THE FRAGMENT WAS REMOVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY. AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR." }, { "mdr_text_key": "331306156", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "331306157", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INSTRUMENT HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM ON 08/04/2022. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT \"A WHEEL HOLDING THE SHEATH CAME OFF AND FELL AND FELL ON A SMALL LOOP WHEN THE SYNCHRO SEAL TOUCHED THE ENDOSCOPE\". FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF DISLODGED DISTAL WASHER BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED DISTAL WASHER AT THE DISTAL END. THE WASHER WAS RETURNED WITH THE INSTRUMENT. ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE. ADDITIONAL TESTING WAS PERFORMED BY A FAILURE ANALYSIS (FA) ENGINEER. THE INITIAL FA TESTING WAS CONFIRMED. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED WASHER AT THE DISTAL END. THE INSTRUMENT PIVOT PIN WAS MICROSCOPICALLY EXAMINED, AND IT WAS DETERMINED THAT THE PIVOT PIN WAS NOT SWAGED PROPERLY, CAUSING THE WASHER TO BECOME MORE EASILY DISLODGED. IT WAS DETERMINED THE ROOT CAUSE OF THE DISLODGED WASHER WAS MANUFACTURING RELATED, AND IT HAD FALLEN DUE TO THE IMPROPERLY SWAGED PIN, WHICH ITSELF IS MANUFACTURING RELATED." } ], "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": "09/03/2022" } ] }