{ "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": "2955842-2022-12936", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220713", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20220613", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20220713", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210915", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2284106", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220713", "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": "L90210916", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20220629", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)L90210916", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Thermal Decomposition of Device", "Arcing", "Thermal Decomposition of Device", "Arcing" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20220713", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "61 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "Asian", "patient_problems": [ "Burn(s)", "Unspecified Tissue Injury", "Burn(s)", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20220613", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15007436", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220614", "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": "295853550", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE THERMAL DAMAGE SEEN ON THE MCS TIP COVER ACCESSORY IS TYPICALLY DUE TO MISHANDLING/MISUSE. THERE WAS NO SIGNS OF THERMAL DAMAGE AT THE DISTAL END OF THE MCS INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS RECEIVED THE MCS TIP COVER ACCESSORY ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE MCS TIP COVER ACCESSORY EXHIBITED LOCALIZED MELTING, WHICH IS INDICATIVE OF ARCING, AT THE CENTER OF THE ACCESSORY SHAFT. THE MCS TIP COVER ACCESSORY WAS RETURNED WITH THE MCS INSTRUMENT THAT WAS USED WHEN THE THERMAL DAMAGE WAS REPORTED. HOWEVER, THE MCS INSTRUMENT DID NOT EXHIBIT ANY SIGNS OF THERMAL DAMAGE ANYWHERE ON THE DISTAL END. THE INSTRUMENT HAD NO ISSUES WHEN DELIVERING ENERGY DURING IN-HOUSE TESTING. THE ARCING COULD NOT BE REPLICATED DURING IN-HOUSE TESTING. THE ROOT CAUSE OF TIP COVER THERMAL DAMAGE IS TYPICALLY ATTRIBUTED TO THE MISHANDLING/MISUSE. ISI HAS RECEIVED THE MCS INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. VISUAL INSPECTION OF THE INSTRUMENT FOUND NO PHYSICAL OR COSMETIC DAMAGE ON THE DISTAL END. NO SIGNS OF ARCING OR THERMAL DAMAGE OF ANY KIND WERE OBSERVED. THE HOUSING WAS REMOVED FROM THE BACK END AND NO PHYSICAL OR THERMAL DAMAGE WAS FOUND. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED AND PASSED. AN ENERGY DELIVERY TEST WAS PERFORMED WHILE THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND PASSED. THERE WAS NO PROBLEM DETECTED. AN IMAGE PROVIDED BY THE CUSTOMER WAS REVIEWED BY AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE) AND THE FOLLOWING INFORMATION WAS RECEIVED: THERE IS A VISIBLE BURN MARK ON THE MCS TIP COVER ACCESSORY. IT IS NOT CLEAR HOW DEEP THE TEAR/HOLE IS, BUT A DEFECT WOULD ALLOW FOR CAUTERY LEAKAGE OR ARCING. A SLIGHT GAP (THE THIN ORANGE LINE AT THE BOTTOM OF THE IMAGE) WAS OBSERVED BETWEEN THE MCS TIP COVER ACCESSORY AND INSTRUMENT SHAFT. FOR PROPER INSTALLATION, NO PART OF THE ORANGE SURFACE SHOULD BE VISIBLE. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. THE LOGS WERE REVIEWED BY ISI ADVANCED FAILURE ANALYSIS ENGINEER (FAE) TEAM AND THE FOLLOWING FINDINGS WERE OBTAINED: THE LOGS WERE REVIEWED AND THERE WERE NO RELEVANT ERRORS SEEN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED LAR PROCEDURE, THERE WAS ARCING THROUGH THE MCS TIP COVER ACCESSORY INSTALLED ON AN MCS INSTRUMENT RESULTING IN AN INJURY TO THE BOWEL. THE SURGEON APPLIED SUTURES TO TREAT THE BOWEL INJURY. BLANK MDR FIELDS FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. PMA/510(K) NUMBER AND ADVERSE EVENT ARE NOT APPLICABLE." }, { "mdr_text_key": "295853551", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THERE WAS ARCING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FROM A LOCATION OTHER THAN THE TIP. THE PATIENT SUSTAINED A RESULTING BURN INJURY TO THE INTESTINAL TRACT. A BACKUP MCS INSTRUMENT WAS USED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OR NURSE AND OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENT AND CANNULA WERE INSPECTED BEFORE USE. THE SURGEON STATED THAT THERE WAS SOMETHING \"WRONG\" WITH THE MCS FROM THE BEGINNING OF THE PROCEDURE BUT NO INFORMATION WAS PROVIDED TO FURTHER DESCRIBE WHAT THE ISSUE WAS. THE GROUNDING PAD WAS PLACED PROPERLY ON THE PATIENT AND THERE WERE NO DEFECTS SEEN. ISI CONTACTED THE SURGEON AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL NOTICED. THE SURGEON REPORTEDLY NOTICED DAMAGE TO THE INSTRUMENT AND/OR ACCESSORY PRIOR TO THE ARCING EVENT. THE CANNULA WAS INSPECTED PRIOR TO USE AND THE PIN GAUGE TEST WAS PERFORMED. IT WAS REPORTED THAT ARCING WAS OBSERVED COMING FROM THE MIDDLE PART OF THE TIP COVER AND THAT THIS GENERATED STEAM FROM THE HEAT. THIS OCCURRED WHILE THE SURGEON WAS PERFORMING THE ABRASION OF THE APPENDIX. THE SURGEON REPORTED THAT THE MCS INSTRUMENT WAS IN CONTACT WITH TISSUE WHEN THE ARCING EVENT OCCURRED, BUT DID NOT TOUCH ANY STAPLES, CLIPS, SUTURES, NOR WAS IT IMMERSED IN LIQUID OR CONTAMINATED WITH BIO DEBRIS. THE SURGEON REPORTED THAT THE ARCING EVENT DAMAGED THE SMALL INTESTINE AND THE SURGEON SUTURED THIS LOCATION TO TREAT THE INJURY. THE PATIENT HAS REPORTEDLY NOT RETURNED TO THE HOSPITAL DUE TO COMPLICATIONS AS A RESULT OF THIS ARCING EVENT. THE CUSTOMER WAS REPORTEDLY USING A VIODV GENERATOR DURING THIS EVENT WITH CUT SET TO 3 AND COAG SET TO 2. THIS EVENT REPORTEDLY OCCURRED WITHIN THE FIRST HOUR OF THIS MCS INSTRUMENT BEING USED. THE SURGEON WAS ALSO USING A 30 DEGREE ENDOSCOPE, A TIP-UP FENESTRATED GRASPER INSTRUMENT, AND ANOTHER, UNSPECIFIED INSTRUMENT WHEN THIS EVENT OCCURRED. THE SURGEON REPORTED THAT THE INSTRUMENTS DID NOT COLLIDE AT ANY POINT. THE SURGEON REPORTED THAT THE WRIST OF THE MCS INSTRUMENT WAS STRAIGHTENED WHEN IT WAS REMOVED PRIOR TO THIS EVENT. DOUBLE-CANNULATION WAS NOT PERFORMED DURING THIS PROCEDURE. THE GROUNDING PAD WAS PLACED ON THE PATIENT¿S LEFT THIGH AND WAS REPORTEDLY PLACED PROPERLY, WITH NO DEFECTS OBSERVED. THE SURGEON SAID THEY BELIEVE THE CAUSE OF THIS ARCING EVENT WAS DAMAGE ON THE MCS TIP COVER ACCESSORY." } ], "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": "" } ] }