{ "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": "2955842-2011-00109", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20110414", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20110315", "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": [ "Foreign", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20110415", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20110414", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20110414", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "76 YR", "patient_sex": "", "patient_weight": "64", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Purulent Discharge", "Fistula", "Inflammation" ] } ], "distributor_city": "", "date_report": "20110315", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2058205", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20110315", "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": "9112103", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SURGEON COMMENTED THAT THE SYSTEM FUNCTIONED PROPERLY AND NO ANOMALIES WERE NOTED DURING THE DA VINCI S SURGICAL PROCEDURE PERFORMED ON (B)(6) 2011. THE SURGEON ADVISED THAT IT COULD NOT DETERMINE AS TO HOW THE FISTULA DEVELOPED AND SUGGESTED THAT THE PANCREAS COULD HAVE BEEN UNINTENTIONALLY DAMAGED DURING THE PROCEDURE AS THE PATIENT WAS REPORTED AS HAVING VISCERAL FAT. HE ALSO SUGGESTED THAT DAMAGE TO THE PANCREASE COULD HAVE BEEN CAUSED BY A THIRD PARTY ENDOSCOPIC FORCEPS OR LIGASURE INSTRUMENTS INSERTED THROUGH THE ASSISTANT PORT. THE SURGEON ADVISED THAT THIS TYPE OF SURGICAL COMPLICATION IS A KNOWN RISK OF FUNDECTOMY PROCEDURES REGARDLESS OF OR SURGICAL TECHNIQUE OR TOOLS USED. PER THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM, INSTRUMENT AND ACCESSORIES WORKED AS INTENDED AND NO SYSTEM MALFUNCTIONS OCCURRED." }, { "mdr_text_key": "1853503", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A SUCCESSFUL DA VINCI S FUNDECTOMY PROCEDURE, HOWEVER, 3 HOURS POST PROCEDURE, A PANCREATIC FISTULA WAS FOUND. DRAINAGE WAS PERFORMED AND AMYLASE LEVELS WERE TESTED. ON (B)(6) 2011, THE DOCTOR DETERMINED THAT THE INSERTS USED FOR DRAINAGE WAS NOT ALLOWING SUFFICIENT DRAINAGE AND AS A RESULT THE SURGEON CLEANED THE PATIENT ENDOSCOPICALLY AND A DRAINAGE TUBE WAS PLACED. ON (B)(6) 2011, THE PATIENT'S RESPIRATORY STATUS BECAME WORSE AND A CT SCAN SHOWED AN ABSCESS INSIDE THE MEDIASTINUM AND THE CHEST CAVITY. IT WAS FOUND THAT THE PATIENT ALSO EXPERIENCED MEDIASTINITIS AND EMPYEMA. DRAINAGE WAS PERFORMED AND THE PATIENT WAS PUT ON A RESPIRATOR. AS OF (B)(6) 2011, THE SITE REPORTED THAT THE PATIENT IS RECOVERING WITH NO FEVER. THE PATIENT IS SAID TO BE RECOVERING WELL WITH ALL SYMPTOMS IMPROVING." } ], "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": "" } ] }