{ "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": "2955842-2021-10099", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210201", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210106", "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": "20210201", "manufacturer_contact_f_name": "DAVID", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "155034", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210201", "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": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/06/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20210201", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210106", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11259299", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210106", "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": "230073470", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE CUSTOMER REPORTED THAT THE MONOPOLAR CURVED SCISSORS (MCS) AND THE MCS TIP COVER ACCESSORY ARE NOT AVAILABLE TO RETURN TO ISI FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. NO IMAGES OR PROCEDURE VIDEOS OF THE EVENT WERE SHARED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE ITEM WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED ITEMS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER ACCESSORY TO FALL OFF OF THE INSTRUMENT. ALTHOUGH THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT, IF THE FAILURE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. THERE WAS INSUFFICIENT PRODUCT INFORMATION AVAILABLE TO DETERMINE THE MANUFACTURE DATE." }, { "mdr_text_key": "230073471", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REGARDING A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE CUSTOMER REACHED OUT WHEN AN MCS TIP COVER ACCESSORY CAME OFF OF A ROBOTIC INSTRUMENT THAT WAS BEING USED. THE CUSTOMER WAS ASKING IF IT WOULD SHOW UP ON AN X-RAY IF THEY COULD NOT FIND IT. THE CUSTOMER ALSO INDICATED THEY DID NOT USE ANY KIND OF LUBRICANT WITH THE MCS INSTRUMENT AND COULD NOT BELIEVE IT CAME OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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 NOTED ON EITHER. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT, AND WAS RETRIEVED USING A LAPAROSCOPIC GRASPER. THE CUSTOMER WAS REMOVING THE INSTRUMENT FROM THE PATIENT WHEN THE TIP COVER FELL. SURGEON DID NOT NOTICE ANY ISSUE WITH INSTRUMENT FUNCTIONALITY AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT. UPON REMOVAL OF THE MCS, THE TIP WAS STRAIGHTENED AND THERE WAS NO RESISTANCE. THERE WAS NO DAMAGE OBSERVED ON THE MCS TIP COVER ACCESSORY. THE INSTRUMENT WAS USED DURING A ONE AND HALF HOUR PROCEDURE. THE PROCEDURE WAS COMPLETED \"AS NORMAL.\" THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED ON THE MCS INSTRUMENT AND THERE WAS NO OVER-INSTALLATION. NO ELECTRO LUBE OR ANY OTHER LUBRICANT WERE USED. THE CUSTOMER USED THE INSTALLATION TOOL TO INSTALL THE MCS TIP COVER ACCESSORY. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY ARE NOT AVAILABLE TO RETURN TO ISI. NO PHOTOS OR IMAGES ARE AVAILABLE FOR REVIEW. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WAS REQUESTED HOWEVER THE CUSTOMER DID NOT PROVIDE THAT INFORMATION. CUSTOMER STATED THAT THIS INFORMATION HAS NOTHING TO WITH THE FACT THE SCISSORS TIP COVER FELL OFF WHEN TAKING OUT OF THE TROCAR. THERE WAS NO HARM TO THE PATIENT. THE CUSTOMER FOUND THE MCS TIP COVER ACCESSORY, BUT WERE WONDERING IF IT WOULD SHOW UP ON EITHER X-RAY OR FLOUORO FOR FUTURE REFERENCE." }, { "mdr_text_key": "335844339", "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." }, { "mdr_text_key": "335844340", "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": "05/24/2023" } ] }