{ "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": "2955842-2020-11173", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201106", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20201008", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "DISTRIBUTOR", "FOREIGN", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "", "date_added": "20201106", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1270518", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201106", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480275-08", "catalog_number": "480275", "lot_number": "M90191020 0074", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201218", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)211031(10)M90191020", "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": "12/21/2020;07/16/2021", "mfr_report_type": "", "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": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201106", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20201008", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10805475", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201008", "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": "326062902", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "326062903", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REFER TO THE FOLLOWING FIELD FOR CORRECTED INFORMATION: B3 (EVENT DATE). REFER TO THE FOLLOWING FIELDS FOR UPDATED INFORMATION: G3, G6, H2, AND H10. THE EVENT DATE HAS BEEN CORRECTED FROM (B)(6) 2020 TO (B)(6) 2020." }, { "mdr_text_key": "322542525", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "61- INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE CURVED SHEARS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND WITH A BROKEN CURVED BLADE. THE BROKEN PIECE, APPROXIMATELY 0.54\" X 0.10\" WAS NOT RETURNED; MATERIAL WAS MISSING. CRACKED OR BROKEN BLADES ARE TRIGGERED BY ANY INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED. IN ADDITION, SCRATCHES ON THE BLADE TIP MAY ALSO LEAD TO PREMATURE BLADE FAILURE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. THE ROOT CAUSE OF THIS FAILURE IS FATIGUE FAILURE DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A BROKEN CURVED BLADE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. INSTRUMENT LOG INVESTIGATION: A REVIEW OF THE INSTRUMENT LOG FOR THE INSTRUMENT (PART #480275, LOT #M90191020-0074) ASSOCIATED WITH THIS EVENT WAS PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON 08-OCT-2020 ON SYSTEM (B)(4). THIS IS A SINGLE USE INSTRUMENT, AND WAS THEREFORE ON ITS FIRST AND FINAL USE." }, { "mdr_text_key": "216603848", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN RMA HAS BEEN ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE ISI DEVICE RETURNED, HOWEVER, ISI HAS NOT YET RECEIVED THE HARMONIC ACE CURVED SHEARS INSTRUMENT FOR EVALUATION. ISI HAS MADE SEVERAL ATTEMPTS TO OBTAIN THE RMA WITH NO SUCCESS. 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. THE HARMONIC ACE CURVED SHEARS INSTRUMENT BATCH SEQUENCE NUMBER WAS NOT PROVIDED. THEREFORE, AN INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME. A REVIEW OF THE SITE'S COMPLAINT HISTORY SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE, OR VIDEO WAS PROVIDED BY THE SITE FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED, BUT AN ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. THE PRODUCT IS NOT IMPLANTABLE." }, { "mdr_text_key": "216603849", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYMECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE CURVED SHEARS INSTRUMENT WAS BROKEN AND FELL INSIDE THE PATIENT. AN X-RAY WAS PERFORMED TO LOCATE THE BROKEN FRAGMENT. A THORACOTOMY WAS PERFORMED TO RETRIEVE THE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS VISIBLE. THE PROCEDURE WAS IN PROGRESS FOR ABOUT 90 MINUTES WHEN THE ISSUE OCCURRED. AN X-RAY WAS PERFORMED TO LOCATE THE BROKEN FRAGMENT AND A THORACOTOMY WAS PERFORMED TO RETRIEVE THE FRAGMENT. THE SURGEON DOES NOT KNOW WHAT CAUSED THE INSTRUMENT TO BREAK AS THERE WERE NO COLLISIONS WITH OTHER INSTRUMENTS OR HARD MATERIAL, AND NOTHING ABNORMAL. THE FRAGMENT FELL WHEN ACTIVATING THE INSTRUMENT, CUTTING TISSUE. A FEW MINUTES BEFORE THE ISSUE OCCURRED, THERE WAS ADVICE ABOUT \"TOO MUCH FORCE APPLIED\" ON THIS INSTRUMENT, BUT NO EXCESSIVE FORCE WAS APPLIED. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA, AND NO DAMAGE WAS NOTICED TO THE CANNULA AFTER THE EVENT OCCURRED. ADDITIONALLY, NO OTHER DAMAGE WAS NOTICED ON THE INSTRUMENT FOLLOWING THE EVENT. A NEW INSTRUMENT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE." } ], "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": "01/13/2021;08/12/2021" } ] }