{ "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": "2955842-2020-10256", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200331", "manufacturer_address_2": "", "pma_pmn_number": "K093217", "date_of_event": "20200221", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER", "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": "20200331", "manufacturer_contact_f_name": "DAVID", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "372314", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200331", "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": "400272-03", "catalog_number": "400272", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200406", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/07/2020;03/05/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250808", "health_professional": "N", "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": "20200331", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "Device Embedded In Tissue or Plaque", "No Known Impact Or Consequence To Patient", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20200305", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "9908789", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200305", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "315671481", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: D10, G4, G7, H2, H3, H6 AND H10. 61 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSERT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED FAILURE WAS CONFIRMED. THE HARMONIC INSERT WAS FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE AT ROUGHLY 0.036¿ FROM THE BASE. THE BROKEN PIECE WAS RETURNED. ANY INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED MAY RESULT IN A CRACKED OR BROKEN BLADE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. SCRATCHES ON THE BLADE TIP MAY ALSO LEAD TO PREMATURE BLADE FAILURE. THE ROOT CAUSE OF THIS FAILURE IS FATIGUE FAILURE DUE TO MISHANDLING/MISUSE. BASED ON THE FAILURE ANALYSIS RESULTS, THE INITIAL MDR REPORT IS BEING RETRACTED AS THE DAMAGE TO THE INSTRUMENT WAS FOUND TO BE DUE TO MISHANDLING/MISUSE AND NOT DUE TO A MALFUNCTION OF THE UNIT." }, { "mdr_text_key": "315671482", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336743396", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336743397", "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. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1. B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO \"REQUIRED INTERVENTION\". H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." }, { "mdr_text_key": "210648474", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE HARMONIC ACE INSERT FOR FAILURE ANALYSIS INVESTIGATION. 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 LOG REVIEW REVEALED THAT THE INSTRUMENT USED IN CONJUNCTION WITH THE REPORTED ACCESSORY (HARMONIC ACE CURVED SHEARS; 420227-07/(B)(4)) WAS LAST USED WAS ON (B)(6) 2020 ON (B)(4) THE INSTRUMENT HAS 17 OF 20 LIVES REMAINING FOR USE. A REVIEW OF THE SITE HISTORY SHOWS NO OTHER COMPLAINTS RELATED TO THIS EVENT. PHOTOGRAPHIC IMAGES OF THE ACCESSORY OR A VIDEO RECORDING OF THE PROCEDURE WERE NOT AVAILABLE FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT A FRAGMENT BROKE OFF AND FELL INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR." }, { "mdr_text_key": "210648475", "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 LOWER FIXED JAW OF THE HARMONIC ACE INSERT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM OR INJURY. DUE TO THE ISSUE, THERE WAS REPORTEDLY A SURGICAL DELAY OF 30 MINUTES OR GREATER. INTUITIVE SURGICAL INC. (ISI) RECEIVED MEDWATCH FORM (B)(4) FOR THE REPORTED EVENT. ADDITIONAL INFORMATION WAS PROVIDED ABOUT THE COMPLAINT: THE SURGEON WAS USING THE ROBOTIC HARMONIC HAND PIECE DURING A ROBOTIC SACROCOLPOPEXY WITH HYSTERECTOMY. THE CONTROL BOX ALARMED TO RELEASE PRESSURE FROM THE JAWS. ONCE THE JAWS WERE OPENED THE SURGEON NOTICED THE BLADE HAD BROKEN OFF OF THE HAND PIECE AND WAS LAYING INSIDE THE PATIENT. ANOTHER GRASPING INSTRUMENT WAS USED TO REMOVE THE BROKEN BLADE FROM THE PATIENT. THE INSTRUMENT WAS REMOVED FROM USE. ISI PERFORMED MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, BUT AS OF THE DATE OF THIS REPORT, NO ADDITIONAL DETAILS ARE AVAILABLE." } ], "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": "05/04/2020;05/24/2023" } ] }