{ "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": "2955842-2020-10034", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200116", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20191218", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200116", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "58696", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200116", "brand_name": "DA VINCI", "generic_name": "CANNULA, STANDARD, REUSABLE", "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": "470002-08", "catalog_number": "", "lot_number": "", "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 Fragmentation", "Material Fragmentation" ], "reporter_state_code": "ID", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20200116", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20191218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9596657", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20191218", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "175239629", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "67/4315 . THE SOURCE AND LOCATION OF THE SHAVING REMAINS UNKNOWN AS OF THE DATE OF THIS REPORT. AFTER A REVIEW OF THE LOGS AND THE TIMESTAMP OF WHEN INSTRUMENTS WERE INSTALLED ON THE SYSTEM, THE ISI INSTRUMENTS AND ACCESSORIES THAT WERE IN USE AT THE TIME OF THE SHAVING BEING IDENTIFIED WERE THE CANNULA AND THE PROGRASP FORCEPS INSTRUMENT. ALTHOUGH THE SOURCE OF THE SHAVING REMAINS UNKNOWN, THIS REPORT IS BEING SUBMITTED FOR THE CANNULA POTENTIALLY RELATED TO THE REPORTED EVENT. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PROGRASP FORCEPS INSTRUMENT POTENTIALLY RELATED TO THE REPORTED EVENT. REFER TO THE EVENT WITH PATIENT IDENTIFIER: ISI REF: (B)(4). ISI HAS NOT RECEIVED THE CANNULA INVOLVED WITH THIS COMPLAINT. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE EVENT TO OCCUR AND WHETHER THE SHAVING WAS RETRIEVED." }, { "mdr_text_key": "175239630", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR SURGICAL PROCEDURE, THE CUSTOMER NOTED A METAL SHAVING AFTER PASSING A NEEDLE THROUGH THE CANNULA. THE CUSTOMER REPORTEDLY ATTEMPTED TO GRAB THE SHAVING WITH A LAPAROSCOPIC INSTRUMENT BUT WAS NOT ABLE TO LOCATE IT. IT WAS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO SEE THE SHAVING ON AN X-RAY AND WAS NOT SURE OF THE SOURCE OF THE SHAVING. THE SIZE AND SHAPE OF THE METAL SHAVING ARE UNKNOWN SINCE THE CUSTOMER DID NOT PROVIDE ANY DETAILS ON THEM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTICED THE SHAVING DURING INSTALLATION OF THE ENDOSCOPE. THE CUSTOMER WAS NOT ABLE TO IDENTIFY THE SOURCE OF THE SHAVING. THE CANNULA AND ENDOSCOPE WERE INSPECTED AFTER THE PROCEDURE AND NO VISIBLE DAMAGE WAS OBSERVED ON EITHER OF THEM. THE INSTRUMENTS USED AT THE TIME OF THE REPORTED EVENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENTS USED AT THE TIME OF THE REPORTED EVENT WERE NOT INSPECTED PRIOR TO USE. NO ADDITIONAL POST-OPERATIVE TESTS OR PROCEDURES WERE PERFORMED TO EITHER CHECK FOR OR RETRIEVE ANY REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THERE IS NO VIDEO RECORDING OF THE SURGICAL PROCEDURE AVAILABLE FOR RETURN TO ISI FOR REVIEW. THE SITE DID NOT PLAN TO RETURN ANY ITEMS TO ISI. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO ADDITIONAL ISSUES REPORTED." } ], "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": "" } ] }