{ "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": "2955842-2021-10528", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210519", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210421", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20210519", "manufacturer_contact_f_name": "DAVID", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "748935", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210519", "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": "M90200719", "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": "10886874112738", "udi_public": "(01)10886874112738(17)220731(10)M90200719", "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": "04/22/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "health_professional": "Y", "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": "20210519", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "36 YR", "patient_sex": "Female", "patient_weight": "52 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210422", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11847315", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210422", "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": "267892466", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE HARMONIC ACE INSTRUMENT FOR EVALUATION. THE CUSTOMER NOTED THAT THE INSTRUMENT WOULD NOT BE RETURNED TO ISI. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. THE LOT NUMBER OF THE HARMONIC ACE INSTRUMENT USED DURING THIS PROCEDURE WAS NOT PROVIDED BY THE CUSTOMER. A LOG REVIEW WAS CONDUCTED AND SHOWED THAT TWO HARMONIC ACE INSTRUMENTS WITH THE SAME LOT NUMBER, BUT DIFFERENT BATCH SEQUENCE NUMBERS, WERE USED ON (B)(6) 2021 WITH SYSTEM RSK8039: HARMONIC ACE INSTRUMENT PART# 480275-08 LOT# M90200719-0139 WAS LAST USED ON (B)(6) 2021 WITH SYSTEM RSK8039. THE INSTRUMENT HAD 0 LIVES REMAINING. THIS DEVICE IS A SINGLE-USE INSTRUMENT AND THEREFORE ONLY HAS ONE USE ALLOTTED TO IT. THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S ONLY ALLOTTED USAGE. HARMONIC ACE INSTRUMENT PART# 480275-08 LOT# M90200719-0144 WAS LAST USED ON (B)(6) 2021 WITH SYSTEM RSK8039. THE INSTRUMENT HAD 0 LIVES REMAINING. THIS DEVICE IS A SINGLE-USE INSTRUMENT AND THEREFORE ONLY HAS ONE USE ALLOTTED TO IT. THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S ONLY ALLOTTED USAGE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS ALSO CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT A FRAGMENT OF THE HARMONIC ACE INSTRUMENT FELL INTO THE PATIENT. AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. WHILE THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY, IF THIS EVENT WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "267892467", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT ONE OF THE PADS ON THE HARMONIC SCALPEL FELL OFF INTO THE PATIENT. THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THE ISSUE HAD OCCURRED AND THE CUSTOMER RETRIEVED THE GREY INSTRUMENT TIP PAD WITH NO ISSUES TO THE PATIENT. IT WAS NOTED THE CUSTOMER DISCARDED THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CLINICIAN INFORMED THE INSTRUMENT WAS INSPECTED PRIOR TO USE. PRIOR TO THE FRAGMENT FALLING, THE INSTRUMENT HAD BEEN IN USE FOR ABOUT 45 \u0013 60 MINUTES. AT THE TIME OF THE REPORTED ISSUE, THE CLINICIAN NOTED THAT THE SURGEON WAS PERFORMING AN EXCISION OF FIBROIDS AND STATED THE HARMONIC INSTRUMENT AND TENACULUM INSTRUMENT COLLIDED. THE SURGEON DID NOT NOTICE AN ISSUE WITH THE INSTRUMENT FUNCTIONALITY DURING THE CASE. IT WAS NOTED THE FRAGMENT FELL OFF INTO THE PATIENT IN THE MIDDLE OF THE CASE AND DID NOT OCCUR DURING AN INSTRUMENT COLLISION. THE WHITE TIP OF THE HARMONIC INSTRUMENT WAS RETRIEVED IN ONE PIECE WITH A GRASPER INSTRUMENT. A VISUALIZATION OF THE CAVITY WAS PERFORMED WITH A ROBOTIC CAMERA TO CONFIRM THE ONE FRAGMENT WAS RETRIEVED. NO ADDITIONAL PROCEDURE, X-RAYS, NOR ULTRASOUNDS WERE PERFORMED. THE CLINICIAN INDICATED THE SURGEON DID NOT KNOW WHY THE PIECE FELL OFF IN THE MIDDLE OF THE CASE. PRIOR TO THE REMOVAL OF THE HARMONIC INSTRUMENT, THE CLINICIAN NOTED THAT THE INSTRUMENT WRIST WAS STRAIGHTENED FOR REMOVAL. AT THE MOMENT OF REMOVAL, THE STAFF DID NOT FIND ANY DAMAGE TO THE INSTRUMENT OR CANNULA. THE CLINICIAN INDICATED THE PATIENT HAD NOT RETURNED TO THE HOSPITAL FOR ANY POST-OPERATIVE COMPLICATIONS. AS FOR THE INSTRUMENT, THE CLINICIAN INFORMED THAT IT WOULD NOT BE RETURNING FOR EVALUATION. IMAGES NOR VIDEO WAS AVAILABLE FOR REVIEW. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY OR HARM." }, { "mdr_text_key": "335847554", "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": "335847555", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "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" } ] }