{ "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": "2955842-2021-10187", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210228", "manufacturer_address_2": "", "pma_pmn_number": "K112584", "date_of_event": "20201222", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20210228", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20191128", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "287780", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20210228", "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": "M90191128", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874111083", "udi_public": "(01)10886874111083(10)M90191128", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/03/2021", "mfr_report_type": "Initial", "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": "20210228", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "32 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210203", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11390888", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210203", "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": "335860740", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335860741", "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. 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": "255386591", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE HARMONIC ACE INSTRUMENT 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 REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. VERIFICATION OF THE PRODUCT AND EVENT DETAILS VIA SYSTEM LOGS CANNOT BE PERFORMED AT THIS TIME BECAUSE THERE WAS INSUFFICIENT PRODUCT INFORMATION PROVIDED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENTS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. ALTHOUGH NO PATIENT HARM OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "255386592", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GYNECOLOGICAL PROCEDURE, THE CUSTOMER REPORTED THE HARMONIC ACE INSTRUMENT JAW BROKE OFF AND FELL INTO THE PATIENT. THERE WERE NO ALARMS OR WARNINGS. ALL PIECES WERE RETRIEVED FROM THE PATIENT, THE INSTRUMENT WAS REMOVED FROM USE AND REPLACED WITH A NEW ONE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 03-FEB-2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT 3902560000-2021-8001 STATING: \"WHEN USING THE ROBOTIC HARMONIC SCALPEL WHEN THE ¿HOT¿ SIDE OF THE JAW BROKE OFF. THERE WERE NO ALARMS OR WARNINGS. ALL PIECES RETRIEVED FROM PATIENT, REMOVED FROM USE AND REPLACED WITH A NEW ONE. NO PATIENT HARM.\" INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENT BROKE AT THE HINGE AND THERE WAS NO SPLINTERING OR SHATTERING OF PIECES. THE FRAGMENT WAS PICKED UP BY A LAPAROSCOPIC INSTRUMENT DURING THE SAME PROCEDURE AND REMOVED FROM THE PATIENT. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR RETAINED FRAGMENTS POST PROCEDURE. THE SURGEON BELIEVES THE INSTRUMENT BROKE DUE TO PRESSURE ON THE INSTRUMENT WHILE OPERATING. THE HARMONIC ACE INSTRUMENT WAS INSPECTED BEFORE USE AND THERE WERE NO ABNORMALITIES SEEN. IT WAS BEING USED FOR DISSECTION WHEN THE INSTRUMENT BROKE. THERE WAS NO COLLISION OF THE INSTRUMENT OR ISSUES WITH FUNCTIONALITY OF THE INSTRUMENT BEFORE ONSET OF EVENT. PRIOR TO BREAKAGE, WHEN THE INSTRUMENT WAS REMOVED, THERE WAS NO RESISTANCE FELT AS IT WAS REMOVED FROM THE CANNULA. THE HARMONIC ACE WAS REPLACED WITH A BACKUP INSTRUMENT AFTER IT BROKE. THE NAME OF THE PROCEDURE WAS ROBOTIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY, FLEX SIGMOIDOSCOPY. THE REPORTER IS NOT SURE WHETHER THE INSTRUMENT WILL BE RETURNED FOR EVALUATION AND IS UNSURE OF THE SYSTEM NUMBER THE INSTRUMENT WAS INSTALLED ON DURING THE REPORTED EVENT. THE NAME OF THE SURGEON, DEMOGRAPHIC INFORMATION OF THE PATIENT, RELEVANT INVESTIGATION AND MEDICAL HISTORY WERE REQUESTED BUT NOT PROVIDED." } ], "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": "05/24/2023" } ] }