{ "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": "2955842-2021-10282", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210320", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210219", "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": "20210320", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20201022", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "430481", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210320", "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": "M90201022", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210312", "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)M90201022", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/06/2021;02/22/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250821", "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": "20210320", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "31 YR", "patient_sex": "Female", "patient_weight": "88 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210222", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11536740", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210222", "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": "324917582", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "324917583", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": ". FOLLOW-UP: ON (B)(6)2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SITE ROBOTICS COORDINATOR TO OBTAIN THE FOLLOWING ADDITIONAL INFORMATION: A CANNULA REDUCER WAS NOT USED IN THE CANNULA FOR THE EVENT REPORTED IN THIS COMPLAINT. THERE WAS NO DIFFICULTY WHEN REMOVING THE INSTRUMENT WHEN IT WAS BEING REMOVED AND THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. IT WAS REPORTED THAT THE MCS INSTRUMENT WAS REMOVED \"GENTLY\" WITH NO RESISTANCE FELT. IT WAS THEN NOTICED THAT THE MCS TIP COVER ACCESSORY HAD FALLEN OFF DURING THE INSTRUMENT REMOVAL." }, { "mdr_text_key": "245402076", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE CUSTOMER DOES NOT KNOW THE LOT NUMBER OF THE MCS TIP COVER ACCESSORY WHICH FELL INTO THE PATIENT, BUT KNOWS IT BELONGS TO ONE OF TWO BATCHES: M90201022 AND M90201117. THIS REPORT IS BEING SUBMITTED FOR THE MCS TIP COVER ACCESSORY WITH LOT NUMBER M9020122 POTENTIALLY RELATED TO THE REPORTED EVENT. A SEPARATE REPORT IS BEING SUBMITTED FOR THE MCS TIP COVER ACCESSORY WITH LOT NUMBER M90201117 POTENTIALLY RELATED TO THE REPORTED EVENT. REFER TO THE EVENT WITH PATIENT IDENTIFIER: (B)(6). NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THE MCS TIP COVER ACCESSORY WAS RETURNED IN ITS ORIGINAL PACKAGE, UNOPENED. THE MCS TIP COVER ACCESSORY WAS INSTALLED ON AN IN-HOUSE INSTRUMENT AND THE INSTRUMENT WAS INSTALLED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE MCS TIP COVER ACCESSORY DID NOT FALL FROM THE INSTRUMENT DURING TESTING. THE INSTRUMENT WAS INSTALLED AND REMOVED FROM THE SYSTEM SEVERAL TIMES WITH NO ISSUES. THE MCS TIP COVER ACCESSORY DID NOT FALL OFF OF THE INSTRUMENT. THE MCS TIP COVER ACCESSORY, WHEN USED AS INTENDED, PROVIDES INSULATION OVER A SECTION OF THE ENDOWRIST MCS INSTRUMENT SO THAT RADIO FREQUENCY (RF) ENERGY IS ONLY AVAILABLE AT THE INSTRUMENT SCISSOR TIPS. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MCS TIP COVER ACCESSORY REPORTEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED. ALTHOUGH THERE WAS NO REPORT OF PATIENT INJURY, UNINTENDED ITEMS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER ACCESSORY TO COME OFF OF THE INSTRUMENT." }, { "mdr_text_key": "245402077", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF OF THE INSTRUMENT WHEN REMOVING IT FROM THE TROCAR. THE SITE STATED THAT THEY DID NOT FEEL AS THOUGH THE MCS TIP COVER WAS LOOSE WHEN PLACING IT ON THE INSTRUMENT AND THAT THE TIP COVER FELL OFF WITHOUT ANY KNOWN CONTACT. THE SITE ALSO STATED THAT ONCE THE SYSTEM WAS UNDOCKED, THE TECHNICIAN NOTICED THAT THE TIP COVER WAS MISSING SO THE SURGEON RE-INSERTED AN ENDOSCOPE AND LOCATED THE MISSING TIP COVER. THE SURGEON REPORTEDLY RE-OPENED ONE OF THE PORTS AND INSERTED A GRASPER IN ORDER TO RETRIEVE THE TIP COVER. IT WAS CONFIRMED THAT THE MCS TIP COVER ACCESSORY WAS SUCCESSFULLY RETRIEVED DURING THE SAME SURGICAL PROCEDURE. ACCORDING TO THE SITE, THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL AND NO RESISTANCE WAS FELT DURING INSTRUMENT REMOVAL THROUGH THE CANNULA. 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 MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT COULD HAVE COLLIDED WITH ANOTHER INSTRUMENT DURING PROCEDURE BUT THAT CANNOT BE DEFINITIVELY CONFIRMED. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE ON THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. THE INSTALLATION TOOL WAS USED AND THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED AND IT WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. NO ELECTROLUBE OR ANY OTHER LUBRICANT WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO THE MCS TIP COVER ACCESSORY INSTALLATION. NO POST-OPERATIVE TESTS WERE PERFORMED ON THE PATIENT." }, { "mdr_text_key": "336760854", "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. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1: 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": "336760875", "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": "06/01/2021;05/24/2023" } ] }