{ "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": "2955842-2025-29119", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250722", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250627", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250722", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1428059", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250722", "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", "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": "N", "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": [ "Arcing", "Arcing" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/10/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251103", "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": "20250722", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20250627", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22565415", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250627", "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": "375531865", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE; WHILE USING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THE PATIENT SUSTAINED A BLADDER BURN. PRIOR TO ACTIVATION, THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED. THE GROUNDING PAD WAS CONFIRMED TO BE CORRECTLY PLACED AND FREE OF DEFECTS. THE ERBE GENERATOR WAS IN USE AT THE TIME, WITH THE COAGULATION MODE SET TO SWIFT: 4. THE INJURY OCCURRED WHILE THE MCS INSTRUMENT WAS ACTIVELY DELIVERING ENERGY FOR DISSECTION OF THE BLADDER NECK. AT THE TIME OF ACTIVATION, THE INSTRUMENT¿S JAWS WERE NEITHER IMMERSED IN FLUID NOR CONTAMINATED WITH CARBONIZED TISSUE OR OTHER BIOLOGICAL DEBRIS. THE MCS TIP COVER ACCESSORY WAS OBSERVED TO HAVE COME INTO CONTACT WITH BLADDER TISSUE, RESULTING IN A THERMAL INJURY. THE BURN WAS ADDRESSED WHILE PERFORMING THE VESICOURETHRAL ANASTOMOSIS. NO ADDITIONAL TISSUE RESECTION WAS REQUIRED, AND THERE WAS NO BLEEDING AS A RESULT OF THE INJURY. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER WAS CONSULTED AND SUGGESTED THE POSSIBILITY OF A SHORT CIRCUIT DUE TO COMPROMISED INSULATION. THIS MAY HAVE CAUSED ENERGY TO BE REDIRECTED TO THE INSTRUMENT¿S SHAFT OR MCS TIP COVER ACCESSORY RATHER THAN FOLLOWING THE INTENDED GROUNDING PATH. DESPITE THE INCIDENT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY USING THE SAME INSTRUMENT AND MCS TIP COVER ACCESSORY. ALTHOUGH NO ARCING WAS OBSERVED DURING THE EVENT, THE MCS TIP COVER ACCESSORY EXHIBITED VISIBLE SIGNS OF DAMAGE UPON POST-PROCEDURE INSPECTION. THE PATIENT EXPERIENCED NO POST-OPERATIVE COMPLICATIONS, AND THERE IS NO CONCERN THAT THIS EVENT WILL RESULT IN ANY LONG-TERM ADVERSE EFFECTS." }, { "mdr_text_key": "375531866", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER WAS PERFORMED: THE IMAGE SHOWS A MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT BESIDE AN MCS TIP COVER ACCESSORY THAT APPEARS TO BE DAMAGED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE." }, { "mdr_text_key": "384088083", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: H2, H11. ADDITIONAL INFORMATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FOR FAILURE ANALYSIS. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED BOTH THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS AND PASSED ENERGY DELIVERY TESTING ACROSS VARIOUS GRIP ORIENTATIONS. THE INSTRUMENT ALSO PASSED THE ELECTRICAL CONTINUITY TEST AND CUTTING TESTS. THE INSTRUMENT WAS FULLY FUNCTIONAL, WITH NO SPARKING, ARCING, OR ANY OTHER PRODUCT ISSUES IDENTIFIED." }, { "mdr_text_key": "384088084", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO 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": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/03/2025" } ] }