{ "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": "2955842-2021-10218", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210308", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210107", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "SZ", "manufacturer_contact_area_code": "408", "date_added": "20210308", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20190726", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "329718", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210308", "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": "480275-08", "catalog_number": "480275", "lot_number": "M90190728 0005", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210323", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/24/2021;02/11/2021", "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": "20210308", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210211", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11441308", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210211", "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": "335844613", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335844614", "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." }, { "mdr_text_key": "324722451", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CUSTOMER HAS RETURNED A HARMONIC ACE INSTRUMENT AS A DEFECTIVE INSTRUMENT, RELATING IT TO THIS COMPLAINT. HOWEVER, THE INITIAL ALLEGATION OF THE REPORTED ISSUE WAS FOR A MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AND CLARIFICATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT. D11- ISI RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE AT ROUGHLY 0.209¿ FROM THE BASE. THE BROKEN PIECE WAS NOT 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. AN ADDITIONAL FINDING NOT REPORTED BY THE CUSTOMER WERE ALSO OBSERVED: THE INSTRUMENT WAS FOUND TO HAVE THE INNER TUBE BROKEN. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE." }, { "mdr_text_key": "324722452", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "243527796", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN RMA HAS BEEN ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE PRODUCT RETURNED; HOWEVER, ISI HAS NOT YET RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT OR THE MCS TIP COVER ACCESSORY FOR EVALUATION. 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. VERIFICATION OF THE ACCESSORY PRODUCT VIA SYSTEM LOGS CANNOT BE PERFORMED BECAUSE ACCESSORY DEVICE PRODUCT DETAILS ARE NOT CAPTURED IN THE SYSTEM LOG. THERE WAS NO PHOTO OR VIDEO PROVIDED BY THE SITE FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. ALTHOUGH THERE WAS NO PATIENT INJURY, IF THE FAILURE WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "243527797", "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 TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT DETACHED AND FELL INSIDE THE PATIENT WHILE REMOVING THE INSTRUMENT THROUGH THE TROCAR. 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 MCS TIP COVER ACCESSORY CAME OFF THE INSTRUMENT WHEN THE TROCAR WAS REMOVED. THE INSTRUMENT WAS CHECKED PRIOR TO USE, THE MCS TIP COVER ACCESSORY WAS INSTALLED PROPERLY, AND NOTHING OUT OF THE ORDINARY WAS OBSERVED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE (NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER INSTALLATION). IT IS UNKNOWN IF THE INSTALLATION TOOL WAS USED. NEITHER ELECTROLUBE NOR ANY OTHER LUBRICANT WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO THE MCS TIP COVER ACCESSORY INSTALLATION. THE MCS TIP COVER ACCESSORY WAS RETRIEVED USING A \"JOHAN\". THE ISSUE OCCURRED WHEN REPLACING THE MCS INSTRUMENT WITH A LARGE NEEDLE DRIVER. THE INSTRUMENT WAS WORKING FINE BUT WE NOTICED THE END OF THE MCS TIP COVER ACCESSORY WAS CRACKED. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE WRIST WAS STRAIGHTENED PRIOR TO REMOVAL OF THE MCS INSTRUMENT. THE PROCEDURE WAS COMPLETED USING A BACKUP MCS TIP COVER ACCESSORY. THE MCS INSTRUMENT HAD 3 REMAINING USES." } ], "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": "04/20/2021;05/24/2023" } ] }