{ "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": "2955842-2020-11282", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201130", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20201104", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SW", "manufacturer_contact_area_code": "408", "date_added": "20201130", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200326", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1385352", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201130", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "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": "400180-14", "catalog_number": "400180", "lot_number": "M90200326", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201209", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)M90200326", "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": "12/10/2020;11/04/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "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": "20201130", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "44 YR", "patient_sex": "Female", "patient_weight": "75 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20201104", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10920967", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201104", "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": "322091491", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "4315-INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY DETACHED FROM THE INSTRUMENT. THE MCS TIP COVER ACCESSORY WAS INSTALLED AND TESTED WITH AN IN-HOUSE INSTRUMENT AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT WAS DRIVEN IN ALL DIRECTIONS WITH THE MCS TIP COVER ACCESSORY REMAINING ON THE INSTRUMENT AT ALL TIMES. THE INSTRUMENT WAS INSTALLED AND REMOVED FROM THE SYSTEM SEVERAL TIMES WITH NO ISSUES. THE MCS TIP COVER ACCESSORY DID NOT FALL OFF. THE MCS TIP COVER ACCESSORY WAS FOUND TO HAVE TEARING AT THE MOUTH ON THE DISTAL END. TEARS WERE AXIALLY ALIGNED WITH THE MCS TIP COVER ACCESSORY AND MEASURED FROM 0.011¿ TO 0.047¿ IN LENGTH. THERE WAS NO SIGN OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS." }, { "mdr_text_key": "335846127", "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": "335846128", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "234285753", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN RMA HAS BEEN ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE ISI DEVICE RETURNED; HOWEVER, ISI HAS NOT RECEIVED THE RMA TO CONFIRM/IDENTIFY ANY REPORTABLE FAILURE MODE(S). A FOLLOW-UP MDR WILL BE SUBMITTED 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 ACCESSORY PRODUCT VIA SYSTEM LOGS CANNOT BE PERFORMED BECAUSE ACCESSORY DEVICE PRODUCT DETAILS ARE NOT CAPTURED IN THE SYSTEM LOG. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE MCS TIP COVER ACCESSORY REPORTEDLY FELL INSIDE THE PATIENT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE, AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER ACCESSORY TO FALL INSIDE THE PATIENT. ALTHOUGH THERE WAS NO REPORTED INJURY AND THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE, UNINTENDED ITEMS FALLING INSIDE THE PATIENT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "234285754", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GYNECOLOGY PROCEDURE, WHILE IN PROCESS OF MOVING THE MONOPOLAR CURVED SCISSORS (MCS) FROM ARM 3 TO ARM 1, THE OPERATING ROOM STAFF NOTICED THE MCS TIP COVER ACCESSORY WAS MISSING. THE MCS TIP COVER ACCESSORY WAS FOUND IN THE PORT/CANNULA AND THEN IT FELL INSIDE THE PATIENT. USING THE ASSISTANT PORT, THE OR STAFF WAS ABLE TO RETRIEVE THE MCS TIP COVER ACCESSORY. ACCORDING TO THE REPORTER, AT THE BEGINNING OF THE PROCEDURE, THE OR STAFF NOTICED THAT THE MCS TIP COVER ACCESSORY WAS UNUSUALLY EASY TO PUT IN PLACE. DURING THE OPERATION, PRIOR TO THE REPORTED ISSUE, THE REPORTER INDICATED THAT THE MCS INSTRUMENT WAS TAKEN OUT ONCE AND CLEANED WITH A DAMP COMPRESS AND BRUSH. FOLLOWING THE EVENT, THE NEW MCS TIP COVER ACCESSORY WAS USED TO CONTINUE WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. FOLLOW-UP WAS PERFORMED AND NEW INFORMATION WAS OBTAINED: AN INSTALLATION TOOL WAS USED TO APPLY THE MCS TIP COVER ACCESSORY. THE INSTRUMENT/ACCESSORY WAS IN USE FOR APPROXIMATELY 3 HOURS. THE MCS DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE. AFTER THE EVENT OCCURRED, THERE WAS NO DAMAGE FOUND TO THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA." } ], "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": "01/04/2021;05/24/2023" } ] }