{ "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": "2955842-2022-15474", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20221123", "manufacturer_address_2": "", "pma_pmn_number": "K133845", "date_of_event": "20221025", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20221123", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220727", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "310009", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20221123", "brand_name": "DA VINCI", "generic_name": "CANNULA SEAL", "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": "470361-08", "catalog_number": "470361", "lot_number": "M11220727", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GCJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/02/2022", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250731", "health_professional": "", "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": "20221123", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "56 YR", "patient_sex": "Male", "patient_weight": "70 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20221025", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15854288", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221025", "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": "304209694", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, A PIECE OF THE CANNULA SEAL FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY." }, { "mdr_text_key": "304209695", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PART FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE FAILURE ANALYSIS EVALUATION AND IF ADDITIONAL INFORMATION IS RECEIVED. VERIFICATION OF THE EVENT DETAILS VIA SYSTEM LOGS CANNOT BE PERFORMED BECAUSE THE ACCESSORY'S USAGE IS NOT PRESENT IN THE LOGS. 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 ALLEGED THAT THE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR." }, { "mdr_text_key": "333097642", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 02-DEC-2022, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE CLINICAL SALES REPRESENTATIVE (CSR) NOTED THAT THE SURGEON HAD FOUND ONE PIECE THAT HAD FALL INTO THE PATIENT, AND WITH VISUAL INSPECTION INTO THE CANNULA SAW WHICH PIECE WAS MISSING. THROUGH VISUAL INSPECTION THE SURGEON WAS ABLE TO CONFIRM THAT ALL FRAGMENTS HAD BEEN RETRIEVED. THERE WERE NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS SUCH AS X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON BELIEVES THAT IT IS POSSIBLE THAT WHEN THE INSTRUMENT WAS INSERTED INTO THE CANNULA THE FRAGMENT BROKE OFF. THE CSR STATED THAT IT WAS TOUGH TO KNOW WHEN THE FRAGMENT BROKE OFF BUT EVENTUALLY THE SURGEON NOTED THE BLUE FRAGMENT. ACCORDING TO THE CSR ALL THE INSTRUMENTS AND ACCESSORIES WERE INSPECTED PRIOR TO USE AND THERE WAS NOTHING OUT OF THE ORDINARY. THE SURGICAL TASK THAT WAS BEING PERFORMED AT THE TIME OF THE REPORTED EVENT WAS GRASPING AND RETRACTING TISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE TIP OF THE INSTRUMENT HIT AND CAUGHT THE SEAL DURING THE SURGICAL PROCEDURE. PER THE CSR IT IS POSSIBLE THAT THE FRAGMENT FELL INSIDE THE PATIENT WHEN THE TIP OF THE INSTRUMENT COLLIDED WITH THE SEAL. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE, AND THE WRIST WAS STRAIGHTENED PRIOR TO REMOVAL BUT WAS NOT 100% STRAIGHT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE CSR STATED THERE WAS DAMAGE TO THE SEAL AFTER THE EVENT OCCURRED. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE CSR DID NOT KNOW IF THE PATIENT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE CSR DID NOT KNOW IF THERE WERE PHOTOGRAPHIC IMAGES OF THE REPORTED ISSUE. THERE WAS NO PATIENT INJURY OR HARM. PATIENT DEMOGRAPHICS WERE NOT 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": "12/16/2022" } ] }