{ "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": "2955842-2021-10504", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210513", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210415", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "20210513", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20201210", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "719078", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210513", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-14", "catalog_number": "400180", "lot_number": "M90201215", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210628", "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)M90201215", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Separation", "Material Separation" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/29/2021;04/16/2021", "mfr_report_type": "", "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": "20210513", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES.", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "67 YR", "patient_sex": "Male", "patient_weight": "96 KG", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210416", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11817547", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210416", "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": "325818300", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D9, G3, G6, H2, H3, H6, AND H10. D14-INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY AND FAILURE ANALYSIS HAS BEEN COMPLETED. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT \"TIP COVER CAME OFF OF SCISSORS DURING A PROCEDURE AND FELL INTO THE PATIENT\". THE MCS TIP COVER ACCESSORY WAS INSTALLED ON AN IN-HOUSE INSTRUMENT AND THEN PLACED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT WAS DRIVEN IN ALL DIRECTIONS AND THE MCS TIP COVER ACCESSORY STAYED IN PLACE AND DID NOT FALL OFF OF THE INSTRUMENT. FAILURE ANALYSIS ALSO FOUND THE ADDITIONAL FINDING WHICH WAS NOT REPORTED BY THE CUSTOMER AND IS NOT RELATED TO THE REPORTABLE EVENT: THE MCS TIP COVER ACCESSORY WAS FOUND TO HAVE GOUGE MARKS AT THE PROXIMAL END. THE GOUGE MARKS WERE APPROXIMATELY 0.058\" - 0.084\" IN LENGTH. THE ROOT CAUSE OF THIS FAILURE WAS ATTRIBUTED TO MISHANDLING." }, { "mdr_text_key": "325818301", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335847785", "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": "335847786", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "250392484", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FOR FAILURE ANALYSIS INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE HAS NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE ITEM IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE MCS INSTRUMENT THAT WAS USED WITH THE MCS TIP COVER ACCESSORY THAT REPORTEDLY FELL INSIDE THE PATIENT WAS RETURNED AND ANALYSIS WAS COMPLETED. THE IN-HOUSE MCS TIP COVER ACCESSORY WAS INSTALLED ON THE INSTRUMENT AND THE INSTRUMENT WAS THEN PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS AND MOVED INTUITIVELY IN ALL DIRECTIONS. THE MCS TIP COVER ACCESSORY DID NOT FALL OFF OF THE INSTRUMENT AT ANY POINT DURING TESTING OR REMOVAL OF THE INSTRUMENT FROM THE SYSTEM. THE REPORTED FAILURE COULD NOT BE CONFIRMED WHEN TESTING THE ASSOCIATED INSTRUMENT. AN ADDITIONAL FINDING FOR THE MCS INSTRUMENT, THAT WAS NOT RELATED TO THE REPORTED EVENT, WAS THAT THE INSTRUMENT HAD BLADE DAMAGE. BOTH BLADES WERE INDENTED WHICH PREVENTED THE BLADES FROM CLOSING. A CUT TEST WAS PERFORMED WHEN THE INSTRUMENT WAS ON THE IN-HOUSE TEST SYSTEM AND THE SCISSORS DID NOT CUT CLEANLY THROUGH 0.006\" LATEX. THE ROOT CAUSE OF THIS UNRELATED FAILURE IS MISHANDLING. A LOG REVIEW WAS NOT CONDUCTED AS NO LOGS ARE AVAILABLE FOR THE MCS TIP COVER ACCESSORY. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. 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 CAME OFF OF THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT. IT IS UNKNOWN WHAT CAUSED THE ACCESSORY TO FALL INSIDE THE PATIENT. ALTHOUGH, THE MCS TIP COVER ACCESSORY WAS RETRIEVED, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED, IF THE FAILURE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "250392505", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT WHEN THE INSTRUMENT WAS TAKEN OUT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITH A BACKUP INSTRUMENT. 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 INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. NO ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED AND IT WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE MCS TIP COVER ACCESSORY WAS INSTALLED WITH AN INSTALLATION TOOL WITHOUT LUBRICANT. THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT DURING THE MCS INSTRUMENT REMOVAL AT THE END OF THE PROCEDURE, AND THE ITEM WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE PROCEDURE AND NO ISSUES WERE NOTICED WITH THE FUNCTIONALITY OF THE MCS. THERE WAS NO REPORT OF RESISTANCE DURING THE REMOVAL OF THE INSTRUMENT. NO DAMAGE WAS NOTED ON THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. THE INSTRUMENT WAS USED FOR LESS THAN 60 MINUTES. THE PROCEDURE WAS COMPLETED ROBOTICALLY. NO PHOTOGRAPHIC IMAGES OF THE DEVICE OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR REVIEW. NO RELEVANT TESTING WAS DONE. IT WAS NOTED THAT THE PATIENT HAD NO RELEVANT PRE-EXISTING CONDITIONS." } ], "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": "07/25/2021;05/24/2023" } ] }