{ "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": "2955842-2020-11207", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201116", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20201016", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20201116", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20190809", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1308126", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201116", "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": "M90190811 0167", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201118", "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)210831(10)M90190811", "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": "11/19/2020;10/22/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250808", "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": "20201116", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20201022", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10849346", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201022", "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": "321549831", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "321549832", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "61 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED DURING FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE TEFLON PAD DAMAGE ON THE CLAMP ARM. A MISSING PIECE FROM THE TIP WAS BROKEN OFF AND NOT RETURNED. THE BROKEN PIECE MEASURED ROUGHLY 0.024\" X 0.072\" IN SIZE. THE TEFLON PAD APPEARED TO BE PUSHED DOWN INTO THE CLAMP ARM, LIKELY CAUSING THE TEETH OF THE TEFLON PAD TO LIFT. THE KNOWN COMMON CAUSE OF THIS FAILURE IS DUE TO MISHANDLING / MISUSE. PRODUCT AND EVENT VERIFICATION: VERIFICATION OF THE PRODUCT AND EVENT DETAILS CANNOT BE PERFORMED VIA SYSTEM LOGS BECAUSE NETWORK CONNECTION WAS NOT AVAILABLE FOR THE SYSTEM AT THE TIME." }, { "mdr_text_key": "336865113", "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": "336865114", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "217153836", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THE PRODUCT'S SEQUENCE NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THEREFORE, VERIFICATION OF THE PRODUCT AND EVENT DETAILS VIA SYSTEM LOGS CANNOT BE PERFORMED AT THIS TIME. REVIEW OF THE PROVIDED IMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT OF \"THORNS CAN BEEN FOUND IN THE WHITE PART\". THE FIRST IMAGE SHOWS A SMALL FRAGMENT OF THE TEFLON PAD THAT HAD SEPARATED OR BROKEN OFF FROM THE INSTRUMENT, AND THE SECOND IMAGE SHOWS A SLIGHTLY DISLODGED TEFLON ON THE CLAMP ARM WITH A PIECE MISSING. NO FURTHER ESCALATIONS REQUIRED FOR THE IMAGE 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. ALTHOUGH THERE WAS NO PATIENT HARM REPORTED, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "217153837", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURE, THE TEFLON PAD OF THE HARMONIC ACE INSTRUMENT FELL INSIDE THE PATIENT. THE HARMONIC ACE INSTRUMENT WAS REMOVED AND \"THORNS\" WERE OBSERVED ON THE TEFLON PAD. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. DUE TO THE ALLEGED ISSUE, THE PROCEDURE WAS DELAYED BY 15 MINUTES. THE CUSTOMER WAS UNABLE TO RELEASE PATIENT DEMOGRAPHIC INFORMATION FOR THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS USED FOR 10 MINUTES PRIOR TO THE BREAKAGE. ALL FRAGMENT(S) WERE RETRIEVED LAPAROSCOPICALLY DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON WAS USING THE INSTRUMENT TO DISSECT TISSUE AND DID NOT HAVE ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE SURGEON HAD NO ISSUES WITH REMOVING THE INSTRUMENT FROM THE ARM PRIOR TO THE BREAKAGE. THERE WAS NO REPORT OF COLLISION WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO INFORMATION WAS PROVIDED PERTAINING TO THE PATIENT'S HISTORY, PRE-EXISTING MEDICAL CONDITIONS, OR TESTS/LABORATORY DATA SPECIFIC TO THE INCIDENT." } ], "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": "12/10/2020;05/24/2023" } ] }