{ "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": "2955842-2022-15362", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20221118", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20221020", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20221118", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "237840", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20221118", "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", "catalog_number": "400180", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20221118", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "66 YR", "patient_sex": "Male", "patient_weight": "128 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20221022", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15827173", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221022", "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": "303944146", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MCS INSTRUMENT OR MCS TIP COVER ACCESSORY INVOLVED WITH THIS EVENT FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. AN ADVANCED INSTRUMENT LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE BY AN ISI ADVANCED FAILURE ANALYSIS ENGINEER (FAE). PER THE FAE, THE LOGS WERE REVIEWED FOR THE MCS INSTRUMENT AND NO ERRORS WERE OBSERVED RELATED TO THE MCS TIP COVER ACCESSORY BECOMING LOOSE. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE MCS TIP COVER ACCESSORY CAME LOOSE WHEN REMOVING THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT'S ABDOMEN. THE MCS TIP COVER ACCESSORY COULD NOT BE FOUND AFTER A LONG SEARCH. AN ADDITIONAL OPEN PROCEDURE WAS PERFORMED IN ORDER TO RETRIEVE THE MCS TIP COVER ACCESSORY FROM A RELATIVELY SUPERFICIAL LOCATION OF SUBCUTANEOUS FAT TISSUE IN THE ABDOMINAL WALL OF THE RIGHT LOWER ABDOMEN. THE CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "303944147", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) TIP COVER ACCESSORY CAME LOOSE WHEN REMOVING THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT'S ABDOMEN. AT THE TIME THE EVENT OCCURRED, THE SURGICAL STAFF WAS IN THE PROCESS OF EXCHANGING THE MCS INSTRUMENT WITH A LARGE NEEDLE DRIVER INSTRUMENT. THERE WAS NO DIFFICULTY FELT WHILE REMOVING THE MCS INSTRUMENT. AFTER THE EVENT OCCURRED, THE MCS INSTRUMENT REMAINED OUTSIDE THE PATIENT FOR THE REMAINDER OF THE PROCEDURE AND WAS NO LONGER USED DURING THE PROCEDURE. PER THE SURGEON, THE MCS TIP COVER ACCESSORY LIKELY CAME LOOSE DURING THE INSTRUMENT CHANGE. THE MSC TIP COVER ACCESSORY APPEARED TO HAVE BEEN PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE WITH NO PART OF THE ORANGE SURFACE VISIBLE AFTER INSTALLATION NOR WAS IT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL HAD BEEN USED; ELECTROLUBE OR ANY OTHER LUBRICANT HAD NOT BEEN APPLIED PRIOR TO INSTALLATION OF THE MCS TIP COVER ACCESSORY. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY HAD BEEN INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS. A CANNULA REDUCER WAS NOT USED. AT THE END OF THE PROCEDURE, AFTER THE MISSING MCS TIP COVER ACCESSORY WAS REGISTERED, THE ENTIRE INTRA-ABDOMINAL SITE WAS SEARCHED WITH THE CAMERA FOR THE REMAINING MCS TIP COVER ACCESSORY, THE TROCARS WERE REMOVED UNDER VISION WITH THE HELP OF THE CAMERA, BUT THE MCS TIP COVER ACCESSORY COULD NOT BE FOUND. THE MCS-BEARING TROCAR CANAL WAS PALPATED WITH A FINGER, BUT THE MCS TIP COVER ACCESSORY COULD NOT BE PALPATED DUE TO OBESITY. THE MCS TIP COVER ACCESSORY COULD NOT BE FOUND AFTER A LONG SEARCH. ON POSTOPERATIVE DAY 1, SONOGRAPHIC EXAMINATIONS AND A CT SCAN WERE PERFORMED. AN ADDITIONAL OPEN PROCEDURE WAS PERFORMED IN ORDER TO RETRIEVE THE MCS TIP COVER ACCESSORY FROM A RELATIVELY SUPERFICIAL LOCATION OF SUBCUTANEOUS FAT TISSUE IN THE ABDOMINAL WALL OF THE RIGHT LOWER ABDOMEN. THE SUBSEQUENT SURGICAL REMOVAL OF THE MCS TIP COVER ACCESSORY OCCURRED DURING IN-PATIENT STAY UNDER A SHORT ANESTHESIA TIME. THERE WERE NO POSTOPERATIVE COMPLICATIONS, AND THE PATIENT HAS SINCE BEEN DISCHARGED HOME. THE MCS INSTRUMENT WAS NOT KEPT AND CANNOT BE RETURNED. THE MCS TIP COVER ACCESSORY IS AVAILABLE FOR RETURN. THERE ARE IMAGES OF THE SLEEVE AVAILABLE." } ], "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": "" } ] }