{ "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": "2955842-2021-11280", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20211010", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "date_of_event": "20210827", "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": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "UK", "manufacturer_contact_area_code": "408", "date_added": "20211010", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1500531", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211010", "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": "M90201127", "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": "10886874111045", "udi_public": "(01)10886874111045(10)M90201127", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Split, Cut or Torn", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/14/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20211010", "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": "20210914", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12602629", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210914", "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": "336863727", "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. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1: B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO \"REQUIRED INTERVENTION\". H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." }, { "mdr_text_key": "336863728", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "283412974", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THE IMAGE PROVIDED BY THE CUSTOMER SHOWS AN OUTLINE OF THE MCS TIP COVER ACCESSORY AND THE CUSTOMER'S SKETCH OF WHERE THE SLIT IS LOCATED. THE ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE MCS TIP COVER ACCESSORY WAS DAMAGED AND HAD A TEAR ON THE GRAY SILICONE AREA WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING/MISUSE. IN THE EVENT THE MCS TIP COVER ACCESSORY IS COMPROMISED, IT IS POSSIBLE FOR ENERGY TO DISCHARGE IN AN AREA OTHER THAN THE INSTRUMENT TIP. PER THE I&A USER MANUAL \"IT IS IMPORTANT TO EXERCISE CAUTION WHEN USING AN ENERGIZED ENDOWRIST MONOPOLAR CURVED SCISSORS INSTRUMENT TO HELP AVOID UNINTENDED CONTACT WITH TISSUE ADJACENT TO THE AREA TO BE CAUTERIZED.\" FAILURE TO FOLLOW THESE PRECAUTIONS WILL RESULT IN ELECTRICAL ARCS FROM THE WRIST AND ALTERNATE SITE BURNS. ALTHOUGH THERE WAS NO PATIENT INJURY THAT OCCURRED AS A RESULT OF THIS ISSUE, IF THE FAILURE WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "283412975", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORT THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF THE INSTRUMENT AND FELL INSIDE THE PORT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE. AFTER IT WAS REMOVED, THE CUSTOMER REPORTED FINDING A SLIT ON THE MCS TIP COVER ACCESSORY THAT RAN FROM THE CLEAR TIP END TO A PORTION OF THE GREY SILICONE SECTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER, HOWEVER, NO FURTHER INFORMATION WAS PROVIDED." } ], "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" } ] }