{ "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": "2955842-2020-11034", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201002", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20200828", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20201002", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200102", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1087764", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201002", "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": "M90200107", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201014", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)220131(10)M90200107", "openfda": { "registration_number": [ "2955842" ], "fei_number": [ "3008615487" ], "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": "10/15/2020;09/09/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250819", "health_professional": "Y", "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": "20201002", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES.", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "No Clinical Signs, Symptoms or Conditions", "Device Embedded In Tissue or Plaque", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20200909", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10618427", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200909", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "209622519", "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 RECEIVED THE RMA TO CONFIRM/IDENTIFY ANY REPORTABLE FAILURE MODE(S). AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE INSTRUMENT BREAKAGE TO OCCUR. SITE HISTORY REVIEW WAS CONDUCTED AND FOUND NO OTHER COMPLAINTS FOR THIS PRODUCT. A REVIEW OF THE INSTRUMENT LOGS WAS PERFORMED FOR A PROCEDURE ON (B)(6) 2020 AT (B)(6), AND FOUND THE FOLLOWING PROCEDURE: TOTAL HYSTERECTOMY PERFORMED BY (B)(6) ON SYSTEM SK2770; HARMONIC ACE PN: 480275-08 // LN: M90200107-0215 // SN: (B)(4). THE INSTRUMENT WAS LAST USED ON (B)(6) 2020 ON SYSTEM SK2770, AND HAD 0 USES REMAINING; IT IS A SINGLE USE ITEM. SYSTEM ERROR LOG REVIEW WAS CONDUCTED FOR A PROCEDURE ON (B)(6) 2020 ON SYSTEM SK2770. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE, THE TIP OF A HARMONIC ACE INSTRUMENT FELL OFF INTO THE PATIENT. THE BROKEN PIECE WAS FOUND AND VISUALLY REMOVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT; NO X-RAY WAS NEEDED AS THE FRAGMENT WAS SEEN AND RETRIEVED VISUALLY. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS AND NO MEDICAL INTERVENTION, OTHER THAN FRAGMENT RETRIEVAL, WAS REQUIRED. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO REPORTED INJURY. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE." }, { "mdr_text_key": "209622520", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE OF A HARMONIC ACE INSTRUMENT BROKE WHEN IN A PATIENT; IT¿S THE 3RD TIME IT HAPPENED WITHIN THE MONTH. THERE WAS NO REPORT OF PATIENT INJURY. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CONSOLE SURGEON: DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE, THE TIP OF A HARMONIC ACE INSTRUMENT FELL OFF INTO THE PATIENT WHILE THE SURGEON WAS OPENING A VAGINAL CUFF. THE BROKEN SINGLE PIECE WAS FOUND AND VISUALLY REMOVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT; NO X-RAY WAS NEEDED AS THE FRAGMENT WAS SEEN AND RETRIEVED VISUALLY. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS AND NO MEDICAL INTERVENTION, OTHER THAN FRAGMENT RETRIEVAL, WAS REQUIRED. THE INSTRUMENT DID TOUCH THE PLASTIC OF THE V-CARE MANIPULATOR. THE INSTRUMENT WAS NEVER REMOVED AND IT WAS IN USE INTERMITTENTLY FOR APPROXIMATELY 15 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS NOT REMOVED AT ANY TIME PRIOR TO THE EVENT. THERE WERE NO POST-OPERATIVE COMPLICATIONS AND THE PATIENT IS RECOVERING APPROPRIATELY. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO REPORTED INJURY." }, { "mdr_text_key": "335845062", "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 AN PRODUCT PROBLEM, AS PREVIOUSLY REPORTED." }, { "mdr_text_key": "335845063", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "320420326", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "4310 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT (PN: 480275-08 // LN: M90200107 0215) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED THE REPORTED COMPLAINT; BLADE BROKE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE AT THE BASE. THE BROKEN PIECE WAS RETURNED. 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." }, { "mdr_text_key": "320420327", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/15/2020;05/24/2023" } ] }