{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2021-10883", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210730", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210702", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210730", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1148602", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210730", "brand_name": "DA VINCI", "generic_name": "HARMONIC ACE", "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": "480275-08", "catalog_number": "480275", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/17/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250818", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20210730", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "67 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20210702", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12256167", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210702", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "325451865", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 08/17/2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT 3301250000-2021-8007 STATING THE FOLLOWING AS THE EVENT: \"DESCRIBE THE EVENT OR PROBLEM: WHITE PIECE INSIDE THE JAWS OF THE HARMONIC ACE LAPAROSCOPIC INSTRUMENT FELL OUT DURING CASE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: LYMPH NODE DISSECTION.\"" }, { "mdr_text_key": "325451866", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "268073693", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS OF THE DATE OF THIS REPORT, THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. AN INSTRUMENT LOG REVIEW WAS CONDUCTED, WHICH RESULTED IN THE FOLLOWING FINDINGS: THE LOGS SHOW THE CUSTOMER USED THE FOLLOWING TWO HARMONIC ACE INSTRUMENTS ON 02-JULY-2021 DURING A MALIGNANT HYSTERECTOMY PROCEDURE ON SYSTEM SK3503, BUT IT IS UNKNOWN WHICH OF THE INSTRUMENTS HAD THE REPORTED ISSUE: HARMONIC ACE INSTRUMENT PART# 480275-08 LOT# M90210216-0123. 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. HARMONIC ACE INSTRUMENT PART# 480275-08 LOT# M90200728-0134. 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 SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE REPORTED COMPLAINT WAS ¿THE TISSUE PAD FELL OFF¿, HOWEVER FROM THE PICTURE THERE DOES NOT APPEAR TO BE A MISSING FRAGMENT FROM THE HARMONIC ACE INSTRUMENT SHOWN. I AM UNSURE IF THE COMPLAINT APPLIES TO BOTH INSTRUMENTS USED DURING THE PROCEDURE HOWEVER, ON THE INSTRUMENT SHOWN THE TEFLON PAD CAN BE SEEN IN WHITE, AND THE BLADE APPEARS TO BE INTACT. THERE IS SOME BIO-DEBRIS BUILDUP AT THE PROXIMAL END OF THE JAW. IF THE INSTRUMENT IS BEING RETURNED, FAILURE ANALYSIS WILL BE ABLE TO CONFIRM ANY DAMAGE OR LACK THEREOF TO THE INSTRUMENT. BASED ON THE INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE HARMONIC ACE TISSUE PAD HAD FALLEN OFF OF THE INSTRUMENT AND IT WAS UNKNOWN WHETHER THE PIECE HAD FALLEN INSIDE THE PATIENT. ALTHOUGH THE LOCATION OF THE ALLEGED MISSING PIECE REMAINS UNKNOWN, A POST-SURGICAL X-RAY WAS PERFORMED ON THE PATIENT TO CHECK IF A FOREIGN OBJECT WAS RETAINED. IN ADDITION, THE CAUSE OF THE INSTRUMENT ISSUE IS UNKNOWN AT THIS TIME AS THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS." }, { "mdr_text_key": "268073694", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE HARMONIC ACE TISSUE PAD HAD FALLEN OFF OF THE INSTRUMENT. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THE TECHNICAL SERVICE ENGINEER (TSE) THAT THE CUSTOMER HAD CALLED HIM AFTER THE CASE AND THEY WERE NOT SURE IF THE TISSUE PAD WAS INSIDE THE PATIENT OR NOT. THE CSR STATED THERE WAS NO PATIENT INJURY TO HIS KNOWLEDGE AND WAS IN THE PROCESS OF GATHERING INFORMATION ABOUT THE INCIDENT. THE CSR REPORTED THAT THE SURGEON WAS ABLE TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE ROBOTIC COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 08-JULY-2021: THE ROBOTIC COORDINATOR CONFIRMED THAT NO FRAGMENTS WERE RETRIEVED FROM INSIDE THE PATIENT. IT WAS STATED THAT AN X-RAY WAS PERFORMED POST THE SURGICAL PROCEDURE AND NO FRAGMENTS WERE OBSERVED. A NEW INSTRUMENT WAS USED TO CONTINUE THE CASE. IT WAS UNKNOWN IF THE PATIENT HAS RETURNED TO THE HOSPITAL POST THE SURGICAL PROCEDURE. THE ROBOTIC COORDINATOR INFORMED THAT THEY PLACED THE INSTRUMENT IN A CART WITH A NOTE TO RETURN IT FOR ANALYSIS. A PICTURE OF THE INSTRUMENT WAS REPORTEDLY AVAILABLE; HOWEVER, WAS NOT PROVIDED AT THE TIME. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ADDITIONAL FOLLOW-UP INFORMATION WAS RECEIVED FROM THE SURGEON ON 26-JULY-2021. IT WAS UNKNOWN IF THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE HARMONIC ACE INSTRUMENT WAS REPORTEDLY USED TWICE DURING THE CASE, AND DURING THE SECOND USE, THE SURGEON NOTED SEEING THE PLASTIC SLEEVE SLIDE FORWARD AND THEN UPWARD WHILE TRANSECTING AROUND THE LIGAMENT. THERE WERE REPORTEDLY NO INSTRUMENT COLLISIONS, AND THERE WAS NO DAMAGE TO THE INSTRUMENT OR THE CANNULA AFTER FINAL REMOVAL OF THE INSTRUMENT. THE SURGEON CONFIRMED THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO OTHER ISSUES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/12/2021" } ] }