{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2020-10930", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200918", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20200821", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200918", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1020367", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200918", "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": "M90200117", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200910", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)M90200117", "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": [ "Arcing", "Arcing" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200918", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20200821", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10554437", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200821", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "211095909", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE ALLEGED OPERATIVE COMPLICATION CANNOT BE DETERMINED. ISI HAS RECEIVED THE MCS TIP COVER ACCESSORY ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT THAT A HOLE WAS IDENTIFIED IN THE GREY AREA OF THE TIP COVER. THE MIDDLE OF THE MCS TIP COVER ACCESSORY BODY EXHIBITED LOCALIZED MELTING, WHICH IS INDICATIVE OF ARCING. A HOLE, APPROXIMATELY MEASURING 0.16\" X 0.09\" WAS NOTICEABLY VISIBLE. MATERIAL WAS MISSING. ANY MISSING MATERIAL IS LIKELY THERMALLY INDUCED, RATHER THAN MECHANICALLY INDUCED. AN ADDITIONAL OBSERVATION NOT REPORTED WAS THAT THE MCS TIP COVER ACCESSORY WAS FOUND TO HAVE TEARING AT THE MOUTH OF THE CLEAR DISTAL END. THE TEAR WAS NOT AXIALLY ALIGNED WITH THE MCS TIP COVER ACCESSORY AND MEASURED 0.17\" IN LENGTH. 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. ADDITIONALLY, A PHOTO OF THE MCS TIP COVER ACCESSORY ASSOCIATED WITH THIS COMPLAINT WAS PROVIDED TO ISI AND EVALUATED. THE PHOTO SHOWS A HOLE IN THE PELLETHANE (GREY) SECTION OF THE MCS TIP COVER ACCESSORY. THE HOLE APPEARANCE IS CONSISTENT WITH UNINTENDED ENERGY ESCAPING THRU THE MCS TIP COVER ACCESSORY. FURTHERMORE, AS NOTED BY THE CSR, A VIDEO OF THE PROCEDURE WAS REVIEWED WITH THE SURGEON AND A HOLE ON THE GREY AREA OF THE MCS TIP COVER ACCESSORY WAS FOUND AFTER THE MCS INSTRUMENT AND A TIP-UP FENESTRATED GRASPER INSTRUMENT COLLIDED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED ABOUT THE EVENT. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE, INCLUDING THE MCS INSTRUMENT, WERE USED IN SUBSEQUENT PROCEDURES, WITH THE EXCEPTION OF THE FOLLOWING: FENESTRATED BIPOLAR FORCEPS (PART #470205-17; LOT #N10191209-0224) AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. TIP-UP FENESTRATED GRASPER (PART #470347-11; LOT #N10190111-0080) AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. MEDIUM-LARGE CLIP APPLIER (PART #470327-09; LOT #N10180702-0104) AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. MEDIUM-LARGE CLIP APPLIER (PART #470327-12; LOT #N10191125-0196) AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. VESSEL SEALER EXTEND (PART #480422-01; LOT #T10190328-0354) IS A SINGLE-USE INSTRUMENT AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. SUREFORM 60 (PART #480460-09; LOT #T91200102-0238) IS A SINGLE-USE INSTRUMENT AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. LARGE NEEDLE DRIVER (PART #470006-12; LOT #N12190805-0191) AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. AS OF 15-SEP-2020, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE BURN INJURIES TO THE BOWEL WHICH REQUIRED REPAIR WITH SUTURES. AFTER THE BURN INJURIES WERE IDENTIFIED, THE SURGICAL STAFF INSPECTED THE MCS TIP COVER ACCESSORY AND FOUND A HOLE. THE CUSTOMER BELIEVE THE BURN INJURIES WERE RELATED TO THE HOLE FOUND ON THE MCS TIP COVER ACCESSORY. AT THIS TIME, THE CAUSE OF THE ALLEGED OPERATIVE COMPLICATIONS IS UNKNOWN. ALSO, ALTHOUGH THERE WAS EVIDENCE OF MISUSE OF THE MCS INSTRUMENT BASED UPON A REVIEW OF A VIDEO OF THE PROCEDURE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN OR UNAVAILABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE." }, { "mdr_text_key": "211095910", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, A BURN INJURY WAS IDENTIFIED ON THE SMALL INTESTINE. THE INTRA-OPERATIVE COMPLICATION WAS FOUND WHILE THE SURGEON WAS CHECKING FOR BLEEDING TOWARDS THE END OF THE PROCEDURE. AFTER THE BURN INJURY WAS IDENTIFIED, THE SURGICAL STAFF INSPECTED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON A MCS INSTRUMENT AND IDENTIFIED A HOLE. THE SITE BELIEVES THE BURN INJURY WAS RELATED TO THE HOLE FOUND ON THE MCS TIP COVER ACCESSORY. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP INSTRUMENT/ACCESSORY. ON 28-AUG-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON AND A NURSE: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) REPORTEDLY REVIEWED A VIDEO OF THE PROCEDURE WITH THE SURGEON. PER THE CSR, A COLLISION WAS OBSERVED INTRA-OPERATIVELY BETWEEN THE MCS INSTRUMENT AND A TIP-UP FENESTRATED GRASPER INSTRUMENT INSTALLED ON ARM #4. THE MCS TIP COVER ACCESSORY WAS REPORTEDLY HIT AND A HOLE WAS IDENTIFIED IN THE GREY AREA OF THE TIP COVER. DURING THE COURSE OF THE PROCEDURE, ARCING OF ELECTRICAL ENERGY WAS OBSERVED. IN ADDITION, 2 INJURIES TO THE INTESTINE WERE CONFIRMED. AS A RESULT OF THE INTRA-OPERATIVE COMPLICATIONS, ADDITIONAL SUTURING WAS PERFORMED. THE INSTRUMENTS WERE INSPECTED PRIOR TO USE AND NO ISSUES WERE IDENTIFIED AT THE TIME. IT WAS REPORTED THAT THE MCS INSTRUMENT IS NOT AVAILABLE FOR RETURN TO ISI FOR EVALUATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }