{ "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": "2955842-2024-22979", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20241212", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20241118", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20241212", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20140916", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2147064", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241212", "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": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20241206", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/16/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20241212", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "73 YR", "patient_sex": "Female", "patient_weight": "93 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20241118", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20912940", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241118", "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": "363349844", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL INC. (ISI) RECEIVED THE SCISSOR TIP COVER ACCESSORY ASSOCIATED WITH THIS COMPLAINT. FAILURE ANALYSIS INVESTIGATIONS FOUND THE TIP COVER TO HAVE TEARING AT THE MOUTH WHERE THE SCISSOR TIPS EXIT. THE TEARS WERE AXIALLY ALIGNED WITH THE TIP COVER AND MEASURED FROM 0.0455\" TO 0.0255\" IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. ISI ALSO RECEIVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WERE NO ARCING ISSUES WITH THE INSTRUMENT." }, { "mdr_text_key": "363349845", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "358965708", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT'S SKIN WAS CHARRED AROUND THE PORT INCISION SITE OF THE CANNULA THAT WAS CONNECTED TO THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS USED IN THE SAME USM 2. IT IS UNCLEAR IF THE MCS INSTRUMENT EXPERIENCED AND ARCING EVENT WHICH COULD HAVE CONTRIBUTED TO THE PATIENT'S CHARRED SKIN AROUND THE CANNULA SITE. THE INCISION BURN WAS CENTERED AROUND THE INCISION AND EXTENDED 1MM. THE PROCEDURE INVOLVED A BIOPSY OF INNER WALLS WITH ARM AT NEARLY 90 DEGREES FROM VERTICAL AND WAS \"EXCEPTIONALLY BLOODY\" WITH FAT \"HANGING OVER INSTRUMENT\". THE MONOPOLAR ENERGY CORD USED IN CONJUNCTION WITH THE MCS INSTRUMENT SHOWED NO EVIDENCE OF DAMAGE TO IT WHEN IT WAS REMOVED. THERE WERE NO NOTED EVENTS OF ARCING INTRAOPERATIVELY. THE PORT SITE WAS CLOSED WITH SUTURE AS NORMAL. IT WAS UNKNOWN IF ANY FURTHER INTERVENTION WAS GIVEN TO THE CHARRING PORT SITE. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED." }, { "mdr_text_key": "358965709", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND TIP COVER ACCESSORY, HOWEVER THE FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED. AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED ELECTRICAL SAFETY TESTS ON THE ERBE GENERATOR, E-100 GENERATOR, VISION SIDE CART (VSC), AND PATIENT SIDE CART (PSC) (WITH ARMS 1, 2, 3, & 4) AND ALL PASSED. NO 3RD PARTY MODIFICATIONS WERE FOUND ON THE SYSTEM. THE E-100 AND ERBE GENERATORS WERE BOTH PLUGGED INTO SAME POWER STRIP THAT WAS PLACED AT BOTTOM OF THE VSC. THE FSE RECOMMENDED PLUGGING THE E-100 AND ERBE INTO ISOLATED DIRECT OUTLETS WHEN POSSIBLE. PERFORMED TEST DRIVE ON SYSTEM WITH METAL CANNULA ON ARMS 2 & 3 WITH MONOPOLAR CURVED SCISSORS. NO EVIDENCE OF ARCING OR HEATING UP ON CANNULA WHEN USING EITHER \"CUT\" OR \"COAG\" FUNCTIONS ON EITHER PORT. THE FSE CONFIRMED ERBE SETTINGS WERE SET TO 35 SEC ACTIVATION TIME AND DUAL PAD MODE. THE TEST DRIVE PASSED. THE ORIGINAL MONOPOLAR CORD WAS UNAVAILABLE BUT NOTED THERE WAS NO EVIDENCE OF DAMAGE TO IT WHEN IT WAS REMOVED. THE FSE INSPECTED THE SUSPECT INSTRUMENT THAT WAS NOT REPROCESSED AND FOUND NO EVIDENCE OF DAMAGE OR SETUP ERROR. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE 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." } ], "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": "02/10/2025" } ] }