{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2021-11284", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20211010", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210917", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20211010", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1500533", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211010", "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": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250811", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20211010", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210917", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12602630", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210917", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "275857198", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) WILL NOT BE RECEIVING THE MCS TIP COVER ACCESSORY AS IT WAS DISCARDED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES SHOW ANY COMPLAINTS FOR OTHER ISSUES RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A LOG REVIEW COULD NOT BE PERFORMED ON THE MCS TIP COVER ACCESSORY BECAUSE THE ITEM DOES NOT GET CAPTURED IN THE LOGS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, IT WAS ALLEGED THAT FRAGMENTS FROM THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE SURGEON LOCATED AND RETRIEVED TWO FRAGMENTS, BUT THEY DID NOT EQUAL THE SIZE OF THE PIECE THAT WAS MISSING FROM THE MCS TIP COVER ACCESSORY. THE LOCATION OF THE MISSING FRAGMENT(S) REMAINS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA." }, { "mdr_text_key": "275857199", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS ORIGINALLY REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS BENT TO THE LEFT AND COULD NOT BE REMOVED THROUGH THE CANNULA. THE MCS INSTRUMENT AND THE CANULA WERE REMOVED TOGETHER FROM THE PATIENT. UPON REMOVAL, IT WAS NOTED THAT FRAGMENTS FROM THE MCS TIP COVER ACCESSORY WERE MISSING AND HAD FALLEN INSIDE THE PATIENT. THE SURGEON LOCATED AND RETRIEVED TWO FRAGMENTS, BUT THEY DID NOT EQUAL THE SIZE OF THE PIECE THAT WAS MISSING FROM THE MCS TIP COVER ACCESSORY. THE LOCATION OF THE MISSING FRAGMENT(S) WAS UNKNOWN. ON 30-SEPTEMBER-2021, ISI CONTACTED THE ROBOTICS COORDINATOR (THE ORIGINAL REPORTER) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE EVENT. THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED BEFORE THE PROCEDURE AND THERE WAS NOTHING NOTED OUT OF THE ORDINARY. SHE DID NOT KNOW WHAT CAUSED THE MCS TO BE DAMAGED AND DID NOT KNOW IF THERE WAS AN INSTRUMENT COLLISION. A ROBOTIC INSTRUMENT OF AN UNKNOWN TYPE WAS USED TO RETRIEVE THE FRAGMENTS. THEY DID AN X-RAY, BUT NO FRAGMENTS WERE VISIBLE. NO ADDITIONAL PROCEDURES WERE REQUIRED TO REMOVE FRAGMENTS. SHE IS NOT AWARE OF ANY PHOTOS OR VIDEOS OF THE ISSUE. SHE WAS NOT AWARE OF THE PATIENT RETURNING TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS. SHE WAS NOT ALLOWED TO PROVIDE ANY PATIENT-RELATED INFORMATION. THE MCS TIP COVER ACCESSORY AND THE FRAGMENTS THAT WERE RETRIEVED HAVE BEEN DISCARDED AND WILL NOT BE RETURNED TO ISI FOR ANALYSIS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }