{ "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": "2955842-2021-11745", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20211214", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20211109", "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": "20211215", "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": "1895817", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211214", "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", "expiration_date_of_device": "20230731", "model_number": "480440-05", "catalog_number": "480440", "lot_number": "L90210718 0046", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20211223", "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": "12/28/2021;11/19/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20211214", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions", "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20211119", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13006181", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211119", "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": "327720171", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "327720172", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D9, G3, G6, H2, H3, H6, AND H10. D11 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. INSPECTION FOUND A DISLODGED WASHER AT THE DISTAL END. THE DISLODGED WASHER WAS RETURNED WITH THE INSTRUMENT. THE KNOWN CAUSE OF THIS ISSUE IS ATTRIBUTED TO MISHANDLING AND MISUSE. AS PART OF INVESTIGATION, THE LOGS WERE REVIEWED AND CONFIRMED NO ERROR TO INDICATE A DEVICE MALFUNCTION." }, { "mdr_text_key": "329896547", "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 DUE TO THE REPORT THAT THE DISTAL PIVOT PIN WASHER FROM 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. B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO \"REQUIRED INTERVENTION\". H1 UPDATED TO INCLUDE \"SERIOUS INJURY\"." }, { "mdr_text_key": "290183442", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, A PIECE OF THE SYNCHROSEAL INSTRUMENT BROKE. THE BROKEN FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE USER CONTINUED WITH THE PROCEDURE USING THE BACKUP INSTRUMENT WITH NO FURTHER ISSUE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: NO INSTRUMENT INSPECTION WAS CONDUCTED PRIOR TO INTRAOPERATIVE USE. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 20 MINUTES, THE INSTRUMENT WAS REMOVED INTRAOPERATIVELY FOR CLEANING PRIOR TO THE BREAKAGE. THE WRIST WAS STRAIGHTENED PRIOR TO REMOVAL. USER WAS UNABLE TO CONFIRM IF THE INSTRUMENTS COLLIDED WITH EACH OTHER OR WHETHER THE FRAGMENT CAME OFF INDEPENDENTLY DURING USE. THE ENTIRE FRAGMENT WAS REMOVED FROM THE PATIENT'S BODY USING SURGICAL FORCEPS. NO ADDITIONAL SURGICAL PROCEDURE OR POSTOPERATIVE TEST REQUIRED AS NO REMAINING FRAGMENT WAS CONFIRMED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS CONFIRMED." }, { "mdr_text_key": "290183443", "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 HAS NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THE PRODUCT. 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. NO CONCLUSIVE DETERMINATION COULD BE MADE BASED ON THIS ANALYSIS. A REVIEW OF THE INSTRUMENT LOG FOR THE SYNCHROSEAL INSTRUMENT LOT# L90210718 / SEQUENCE 0046 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON THE REPORTED EVENT DATE OF (B)(4) 2021 ON SYSTEM (B)(4). THE INSTRUMENT IS A SINGLE USE INSTRUMENT. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE DISTAL PIVOT PIN WASHER FROM 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 PIN 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. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE." } ], "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": "01/21/2022;06/30/2022" } ] }