{ "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": "2955842-2020-11409", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201228", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20201201", "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": "SP", "manufacturer_contact_area_code": "408", "date_added": "20201228", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200522", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1545282", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201228", "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": "M9200522", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210325", "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)M9200522", "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": "03/26/2021;12/01/2020", "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": "20201228", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20201201", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11084784", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201201", "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": "335847773", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335847774", "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": "324600008", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "324600009", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: D9, G3, G6, H2, H3, H6, AND H10. D02- INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSOR (MCS) TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE REPORTED COMPLAINT. THE MCS TIP COVER ACCESSORY WAS FOUND TO HAVE TEARING AT THE MOUTH. THE TEAR MEASURED 0.197\" IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF THE TEAR. TEARS AT THE MOUTH ARE MOST COMMONLY CAUSED BY REPEATED THERMAL AND MECHANICAL STRESSES. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. THE MCS INSTRUMENT USED WITH THE MCS TIP COVER ACCESSORY WAS ALSO RETURNED AND ANALYSIS WAS COMPLETED. FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE THE BANANA PLUG BROKEN AT THE PROXIMAL END. THE METAL HOUSING THAT SURROUNDS THE PIN WAS BROKEN. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING. THERE WAS NO DAMAGE FOUND TO THE INSTRUMENT'S MAIN TUBE OR TUBE EXTENSION. HOWEVER, THERE WAS BLADE DAMAGE IDENTIFIED. BOTH BLADE EDGES WERE INDENTED, WHICH PREVENTED THE BLADES FROM CLOSING. THE ROOT CAUSE OF THESE MECHANICAL INDENTATIONS IS TYPICALLY ATTRIBUTED TO MISHANDLING." }, { "mdr_text_key": "251643238", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT RECEIVED 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. 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. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED ITEMS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE ISSUE TO OCCUR. ALTHOUGH THERE WAS NO PATIENT INJURY REPORTED, IF THE ISSUE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "251643239", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE. 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 CUSTOMER STATED THAT THE MCS TIP COVER ACCESSORY WAS RETRIEVED USING A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. IT WAS NOTED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES IDENTIFIED, AND NO ISSUES WERE NOTED DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY WAS INSTALLED WITH THE INSTALLATION TOOL AND ELECTRO LUBE WAS NOT APPLIED TO THE MCS PRIOR TO INSTALLATION. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS." } ], "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": "04/22/2021;05/24/2023" } ] }