{ "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": "2955842-2021-11194", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210926", "manufacturer_address_2": "", "pma_pmn_number": "K112584", "date_of_event": "20210722", "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": "WANG", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20210926", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20191205", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1428495", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210926", "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": "400272-03", "catalog_number": "400272", "lot_number": "M90191205", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20211005", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111083", "udi_public": "(01)10886874111083(10)M90191205", "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": "10/06/2021;08/31/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20210926", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210831", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12530931", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210831", "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": "327131045", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "327131046", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REFER TO THE FOLLOWING FIELDS FOR UPDATED INFORMATION: D9, G3, G6, H3, H6, AND H10. D11 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE CURVED SHEARS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. INSPECTION FOUND DAMAGE ON THE CURVED BLADE ¿ THE BROKEN PIECE, APPROXIMATELY 0.40\" X 0.10\" WAS NOT RETURNED FOR EVALUATION. IT IS KNOWN THAT INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN A CRACKED OR BROKEN BLADE. SCRATCHES ON THE BLADE MAY LEAD TO PREMATURE BLADE FAILURE. THE SYSTEM WILL DISPLAY AN ERROR MESSAGE AND WILL SEIZE TO WORK ACCORDINGLY ONCE IT DETECTS ANY BLADE DAMAGE. THE KNOWN CAUSE OF THIS ISSUE IS ATTRIBUTED TO MISHANDLING/MISUSE." }, { "mdr_text_key": "336869422", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336869423", "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": "273318825", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS REQUESTED THAT THE HARMONIC ACE CURVED SHEARS BE RETURNED FOR EVALUATION, BUT THE INSTRUMENT HAS NOT YET BEEN RECEIVED. 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 REVIEW OF THE COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THE PRODUCT. THE COMPLETE PRODUCT INFORMATION (BATCH SEQUENCE OF THE LOT NUMBER) WAS NOT SUBMITTED WITH THE REPORT. AS A RESULT, SYSTEM AND INFORMATION LOG REVIEWS COULD NOT BE PERFORMED WITHOUT THE FULL PRODUCT INFORMATION. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, AN UNSPECIFIED PART OF THE HARMONIC ACE CURVED SHEARS WAS DAMAGED. THE BROKEN FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED LAPAROSCOPICALLY THROUGH THE ASSIST PORT DURING THE SAME SURGICAL PROCEDURE. ALTHOUGH IT WAS RETRIEVED WITHOUT PATIENT HARM, ADVERSE OUTCOME OR INJURY, A FRAGMENT FALLING INSIDE THE PATIENT COULD POTENTIALLY RESULT IN AN ADDITIONAL SURGICAL PROCEDURE." }, { "mdr_text_key": "273318846", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY PROCEDURE, THE HARMONIC ACE CURVED SHEARS BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED LAPAROSCOPICALLY THROUGH THE ASSIST PORT DURING THE SAME SURGICAL PROCEDURE. THE USER COMPLETED THE PROCEDURE USING A BACKUP INSTRUMENT WITH NO FURTHER ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 30 MINUTES BEFORE THE EVENT OCCURRED. THE INSTRUMENT WAS REMOVED INTRAOPERATIVELY FOR CLEANING. NO FURTHER DETAILS WERE AVAILABLE." } ], "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": "10/31/2021;05/24/2023" } ] }