{ "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": "2955842-2014-00209", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140110", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131202", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140113", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "20282", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140110", "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": "DA", "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": "CO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20140110", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Fever", "Sepsis", "Injury" ] } ], "distributor_city": "", "date_report": "20131212", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3568912", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140113", "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": "4217861", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI PROSTATECTOMY PROCEDURE, A PATIENT RETURNED TO THE HOSPITAL 3 DAYS LATER AND WAS FOUND TO HAVE SUSTAINED A COLON INJURY. THE INITIAL REPORTER OF THIS COMPLAINT, THE ROBOTICS COORDINATOR, INDICATED THAT THE PATIENT UNDERWENT A DIVERTING COLOSTOMY PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR FROM THE SITE. THE ROBOTICS COORDINATOR STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI PROSTATECTOMY PROCEDURE. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT RETURNED TO THE HOSPITAL 3 DAYS POST-OPERATIVELY WITH COMPLAINTS OF ABDOMINAL PAIN AND FEVER. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE AND WAS FOUND TO HAVE SEPSIS AND AN UNSPECIFIED COLON INJURY. THE ROBOTIC COORDINATOR STATED THAT A TEMPORARY COLOSTOMY WAS PLACED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT WAS TO RETURN TO THE HOSPITAL AT A LATER DATE FOR FURTHER EVALUATION AND POSSIBLE PLACEMENT OF A BOWEL ANASTOMOSIS." }, { "mdr_text_key": "11433653", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE DA VINCI PROSTATECTOMY INVOLVED WITH THIS COMPLAINT. ACCORDING TO THE SURGEON, THE PATIENT REQUIRED A DIVERTING COLOSTOMY. THE SURGEON INDICATED THAT THE DA VINCI SURGICAL PROCEDURE WAS PERFORMED WITHOUT OBVIOUS COMPLICATING INTRA-OPERATIVE MECHANICAL OR ANATOMICAL FACTORS. THE SURGEON DENIED HAVING ANY DIFFICULTY IN THE POSTERIOR DISSECTION. THE SURGEON INDICATED THAT THE DEVELOPMENT OF THE FISTULA CAME AS A SURPRISE. THE DA VINCI SURGICAL PROCEDURE WAS NOT RECORDED. HE DENIED OBSERVING ANY VISIBLE SIGNS OF ARCING, SPARKING, OR HAVING NOTICED THE SHAFT PORTION OF AN INSTRUMENT RESTING AGAINST THE RECTAL TISSUE. THE SURGEON REFERRED THE PATIENT TO A GENERAL SURGEON FOR MANAGEMENT AND WAS UNAWARE OF THE TYPE OF COLONIC INJURY THAT WAS FOUND. THE SURGEON WAS ALSO UNSURE ABOUT WHAT THE GENERAL SURGEON FOUND AND WHETHER THE INJURY APPEARED TO BE THERMAL OR DIRECT INJURY. ACCORDING TO THE SURGEON, THE PATIENT IN QUESTION WAS DOING WELL NOW AND RECENTLY HAD HIS DIVERSION COLOSTOMY TAKEN DOWN." }, { "mdr_text_key": "11434902", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE DEVELOPED SEPSIS AND SUSTAINED AN UNSPECIFIED COLON INJURY AFTER UNDERGOING A DA VINCI PROSTATECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURIES ARE UNKNOWN." } ], "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": "01/13/2014" } ] }