{ "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": "HOSPITAL", "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": "2955842-2015-00463", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150320", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140206", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150320", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "191237", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150320", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20150320", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Burn", "Pain", "Tachycardia", "Injury", "Alteration In Body Temperature", "No Code Available" ] } ], "distributor_city": "", "date_report": "20150218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4621671", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150218", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "13103396", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. THE CAUSE OF THE SMALL BOWEL INJURIES SUSTAINED BY THE PATIENT IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF 02/06/2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE INJURIES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI COLECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED TWO SMALL BOWEL INJURIES THAT WERE REPAIRED WITH SUTURES. HOWEVER, AT THIS TIME, THE CAUSE OF THE SMALL BOWEL INJURIES IS UNKNOWN." }, { "mdr_text_key": "5588357", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI TOTAL COLECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A POSSIBLE THERMAL BURN TO THE SMALL BOWEL POST-OPERATIVELY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE POST-OPERATIVE COMPLICATION WAS IDENTIFIED ON POST-OPERATIVE DAY 11. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OBSERVED AND NO REPORTS OF ANY ARCING OF ENERGY FROM AN INSTRUMENT. ON (B)(6) 2015, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR. SHE INDICATED THAT SHE WAS IN AND OUT OF THE DA VINCI SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR ISSUES WITH THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES. TO HER KNOWLEDGE, THE PATIENT WAS TAKEN BACK TO THE OR ON AN UNSPECIFIED DATE FOR REPAIR OF A POSSIBLE THERMAL INJURY TO THE SMALL BOWEL. THE ROBOTICS COORDINATOR DID NOT KNOW WHAT THE SUSPECTED CAUSE WAS FOR THE THERMAL INJURY. AFTER THE THERMAL INJURY WAS REPAIRED, THE PATIENT WAS SENT TO A LARGER MEDICAL FACILITY FOR OBSERVATION AND FURTHER ASSESSMENT. THE ROBOTICS COORDINATOR WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ON (B)(6) 2015, ISI CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE SURGEON, THE DA VINCI TOTAL COLECTOMY PROCEDURE WAS COMPLETED WITH NO INTRA-OPERATIVE COMPLICATIONS OR ISSUES OBSERVED WITH THE DA VINCI SURGICAL SYSTEM. THE SURGEON STATED THAT THERE WERE NO INSTRUMENT COLLISIONS OR EVIDENCE OF ARCING OBSERVED. THE ESU SETTINGS USED BY THE SURGEON WERE 22 CUT AND 22 COAG. THE SURGEON STATED THAT THE PROCEDURE WAS LENGTHY AND TOOK ABOUT 4 HOURS DUE TO THE COMPLEXITY OF THE CASE. ON POST-OP DAY 6 OR 8, THE PATIENT PRESENTED WITH SYMPTOMS OF PERSISTENT TACHYCARDIA, ILEUS, INTERMITTENT TEMPS, AND PAIN. THE SURGEON SUSPECTED THAT THE PATIENT HAD A SWOLLEN BOWEL DUE TO A BOWEL OBSTRUCTION OR POSSIBLE TWISTING OF THE BOWEL. THE PATIENT WAS BROUGHT BACK TO THE ER AND A LAPAROTOMY WAS PERFORMED. THE PATIENT WAS FOUND TO HAVE AN ABDOMEN FULL OF BILE AND 2 AREAS OF LEAKS IN THE JEJUNUM THAT WERE INCHES APART FROM EACH OTHER AT THE LEVEL OF THE MESENTERIC BOWEL. THE SURGEON DESCRIBED THE LEAKS AS POSSIBLE SEROSAL RENTS OR THERMAL BURNS OF UNKNOWN ETIOLOGY. THERE WAS NO EVIDENCE OF A BOWEL OBSTRUCTION. THE SURGEON DID NOT KNOW WHAT CAUSED THE LEAKS WHICH HE REPAIRED WITH SUTURES. AT THIS TIME, THE PATIENT STILL HAS A TRACHEOSTOMY, CAN'T EAT, AND HAS BEEN HOSPITALIZED FOR 35 DAYS. THE SURGEON INDICATED THAT THE PATIENT WILL LIKELY RECOVER BUT STILL HAS A LONG ROAD AHEAD." } ], "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": "" } ] }