{ "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": "2955842-2020-10915", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200916", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20200824", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20200916", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200109", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1006997", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200916", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-14", "catalog_number": "400180", "lot_number": "M90200109", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200923", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)M90200109", "openfda": { "registration_number": [ "2955842" ], "fei_number": [ "3008615487" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break", "Break" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/23/2020;08/24/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250819", "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": "20200916", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20200824", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10544168", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200824", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "207346104", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. AN RMA HAS BEEN ISSUED REQUESTING TO HAVE THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY RETURNED; HOWEVER, ISI HAS NOT RECEIVED THE RMA TO CONFIRM/IDENTIFY ANY REPORTABLE FAILURE MODE(S). SYSTEM LOG REVIEWS DO NOT INCLUDE INFORMATION RELATED TO INSTRUMENT ACCESSORIES SUCH AS THE MCS TIP COVER ACCESSORY. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER ACCESSORY TO FALL FROM THE MCS INSTRUMENT. ALTHOUGH THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT, IF THE MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "207346105", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THERE WAS EXCESSIVE MOBILITY OF THE TIP COVER CAUSING IT TO FALL INTO THE SURGICAL SITE. THE TIP COVER WAS RETRIEVED AND THERE WAS NO CONSEQUENCES TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) PERFORMED MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THIS EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO MORE DETAILS HAVE BEEN PROVIDED." }, { "mdr_text_key": "336640259", "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. B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\" H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." }, { "mdr_text_key": "320904409", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PRODUCT EVALUATION INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: IT WAS REPORTED THAT THE ISSUE OCCURRED DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WRIST WAS NOT STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE ON THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. IT IS UNKNOWN HOW LONG THE INSTRUMENT/ACCESSORY WAS IN USE. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. THE INCIDENT OCCURRED AT THE END OF THE PROCEDURE WHICH HAD BEEN COMPLETED USING THE MCS INSTRUMENT AND TIP COVER ACCESSORY. THE ISSUE CAUSED A PROCEDURE DELAY OF APPROXIMATELY 20 MINUTES. 4307- INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE TIP COVER WAS FOUND TO HAVE TEARING AT THE MOUTH ON THE DISTAL END. TEARS WERE NOT AXIALLY ALIGNED WITH THE TIP COVER AND MEASURED 0.19\" AND 0.23\" IN LENGTH. AS A RESULT OF THE PHYSICAL DAMAGE, THE INTEGRITY AND THE SECUREMENT OF THE TIP COVER WHEN ATTACHED ONTO THE TUBE EXTENSION OF THE MCS WAS COMPROMISED. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. TEARS AT THE MOUTH ARE MOST COMMONLY CAUSED BY REPEATED THERMAL AND MECHANICAL STRESSES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/19/2020;05/24/2023" } ] }