{ "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": "2955842-2019-10268", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20190412", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20110414", "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": [ "CONSUMER", "FOREIGN" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20190412", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "301975", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190412", "brand_name": "DA VINCI", "generic_name": "DA VINCI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20190412", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence", "Incontinence" ] } ], "distributor_city": "", "date_report": "20190329", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8509536", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190329", "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": "141779955", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. AT THIS TIME, THE SPECIFIC DA VINCI SURGICAL SYSTEM USED DURING THE RADICAL PROSTATECTOMY PROCEDURE IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT CLAIMED THAT HE HAS BEEN ¿COMPLETELY INCONTINENT.¿ HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM OCCURRED." }, { "mdr_text_key": "141779956", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE ON (B)(6) 2011, THE PATIENT CLAIMED THAT HE HAS BEEN \"COMPLETELY INCONTINENT.\" ACCORDING TO THE PATIENT, THE SURGEON¿S OPERATIVE REPORT NOTED NO COMPLICATIONS. PER THE PATIENT, A NURSING NOTE INDICATED HE HAD ¿EXTRAORDINARILY STRONG PAIN IN THE ABDOMINAL CAVITY AFTER THE OPERATION.¿ THE PATIENT WAS DISCHARGED ON (B)(6) 2011, WITH A ¿LYING BLADDER CATHETER.¿ THE CATHETER WAS REMOVED ON AN UNSPECIFIED DATE AT A REHABILITATION CLINIC AND ¿CLEAR URINARY INCONTINENCE WAS OBSERVED.¿ FOUR WEEKS POST-OPERATIVELY, THE PATIENT CLAIMED THAT ¿20-25 URINARY CATHETERS WERE NEEDED PER DAY.¿ SIX MONTHS POST-OPERATIVELY, THE PATIENT INDICATED THAT 15 CATHETERS WERE NEEDED. ON (B)(6) 2012, THE PATIENT REPORTEDLY UNDERWENT ¿URODYNAMIC TESTING¿ BY A PHYSICIAN AT ANOTHER HOSPITAL. THE PATIENT INDICATED THAT THE PHYSICIAN NOTED THE FOLLOWING IN HIS MEDICAL REPORT: ¿THERE¿S COMPLETE INCONTINENCE AFTER RADICAL PROSTATECTOMY WITH DAVINCI.¿ IN RELATION TO A LOW FILLING CAPACITY OF THE BLADDER, THE PATIENT QUESTIONED AS TO WHETHER \"SERIOUS ERRORS WERE MADE IN THE RECONSTRUCTION OF THE BLADDER NECK.\"" } ], "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": "" } ] }