{ "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": "2955842-2012-00343", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20120720", "manufacturer_address_2": "", "pma_pmn_number": "K011002", "date_of_event": "20080118", "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": [ "Other", "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120807", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120720", "brand_name": "DA VINCI 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": "IS1200 A4.3P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20120720", "sequence_number_treatment": [ "DA VINCI SYSTEM, INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence", "Pain", "Injury" ] } ], "distributor_city": "", "date_report": "20130110", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2664013", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120625", "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": "2820643", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON JUNE 25, 2012, A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2008, PROVIDED INTUITIVE SURGICAL INFORMATION REGARDING THEIR POSTSURGICAL EXPERIENCE. THE PATIENT INDICATED THAT THEIR PROCEDURE WAS SUCCESSFUL IN REMOVING CANCER, AS THE PATIENT IS STILL CANCER FREE 4.5 YEARS AFTER THE PROCEDURE. HOWEVER, THE PATIENT ALLEGES NUMEROUS COMPLICATIONS THROUGH THE CASE: THE PATIENT CLAIMS THAT DURING THE SURGERY THERE WAS DAMAGE TO HIS VEIN, A SCRATCH ON HIS RIGHT EYE AND DAMAGE TO HIS PENIS CAUSING A CLOSED URETHRA. THE PATIENT REPORTED THAT THE PROCEDURE LEFT HIM INCONTINENT, AND IMPOTENT. THE PATIENT ALSO REPORTED THAT THE PROCEDURE HAS CAUSED HIM TO HAVE PAIN DURING ORGASM, AND HAVE PAIN IN THE LEGS AND GROIN. THE PATIENT ALSO ALLEGES THAT A SECOND PROCEDURE WAS REQUIRED TO REPAIR A GROIN HERNIA. THE PATIENT ALLEGES THAT HE MIGHT NOT HAVE UNDERWENT SURGERY HAD THEY SEEN THE RECOMMENDATION FROM (B)(4), WHICH HE CLAIMS, SUGGESTS MEN NOT GET SCREENED FOR PROSTATE CANCER PARTLY BECAUSE IT RESULTS IN OVERTREATMENT." }, { "mdr_text_key": "10449877", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "9984344", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "POST-OPERATIVE INCONTINENCE AND IMPOTENCE IS CONSIDERED A KNOWN AND ASSESSED NORMAL RISK OF PROSTATECTOMY PROCEDURES, AND CAN DEVELOP REGARDLESS OF THE MODALITY USED TO PERFORM THE SURGERY. LIKEWISE, MANY COMPLICATIONS LISTED: CHANGES IN ORGASM, STERILITY, LYMPHEDEMA, DECREASE IN PENIS LENGTH, INGUINAL HERNIA ARE ALSO POTENTIAL COMPLICATIONS FROM PROSTATECTOMY SURGERY. A REVIEW OF SYSTEM LOGS FOR THE DATE OF SURGERY INDICATES NO SYSTEM MALFUNCTIONS OCCURRED. ADDITIONALLY THERE IS NO ALLEGATION OF SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTION. COMPLAINTS THAT THE PATIENT FILED WITH THE (B)(4) ALSO DETERMINED, THE CARE RENDERED IN THIS CASE WAS CONSISTENT WITH THE STANDARD OF PRACTICE IN THE COMMUNITY. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE FROM THE HOSPITAL. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." } ], "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": "01/10/2013" } ] }