{ "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": "2026-09-22", "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": "2955842-2012-00064", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20120216", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20101022", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "UNKNOWN", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20120731", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120216", "brand_name": "DA VINCI S SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, NAY", "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": "US", "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": "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": [ "Leak/Splash" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20120216", "sequence_number_treatment": [ "DA VINCI S INSTRUMENTS", " AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "70 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence" ] } ], "distributor_city": "", "date_report": "20130110", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2467769", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120309", "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": "9649820", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "POSTOPERATIVE 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. PER THE INFORMATION PROVIDED, NO SYSTEM MALFUNCTIONS WERE ALLEGED. OUR RECORDS INDICATE THAT THE SURGEON WHO PERFORMED THE PT'S PROCEDURE WAS TRAINED TO USE THE DA VINCI S SURGICAL SYSTEM WHILE CONDUCTING THEIR RESIDENCY. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE TO THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "2488681", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, A PT WHO UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2010, PROVIDED INTUITIVE SURGICAL INFORMATION REGARDING THEIR POSTSURGICAL EXPERIENCE. THE PT INDICATED THAT THEIR PROCEDURE WAS COMPLETED IN 5.5 HOURS AND THE DAY AFTER SURGERY, THEIR JP DRAIN FILLED WITH URINE AND LEAKING OUTSIDE OF THE CATHETER OCCURRED. THE PT SPENT 6 RECOVERY DAYS IN THE HOSPITAL. THEIR LEAKING CATHETER WAS IN PLACE FOR 5 WEEKS, WITH THE JP DRAIN IN PLACE FOR 5+ WEEKS. THE PT REPORTED THAT THE PROCEDURE LEFT THEM INCONTINENT AND IMPOTENT. THE PT ALSO INDICATED THAT A SECOND SURGERY HAS BEEN PLANNED TO INSTALL AN IUS (INTERNAL URETHRAL SUPPORT). THE PT ALLEGES THAT THEIR SURGERY OUTCOME MAY HAVE BEEN DIFFERENT IF THE PROCEDURE HAD BEEN PERFORMED BY A \"QUALIFIED\" SURGEON." }, { "mdr_text_key": "10348771", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)" }, { "mdr_text_key": "17179449", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, THE HOSPITAL'S DIRECTOR OF RISK MANAGEMENT INFORMED INTUITIVE SURGICAL THAT THE PATIENT'S POSTSURGICAL COMPLICATIONS WERE IN NO WAY RELATED TO THE USE OF THE DA VINCI S SURGICAL SYSTEM. THE DIRECTOR ALSO INDICATED THAT THE HOSPITAL WAS UNABLE TO RELEASE ANY MORE INFORMATION WITHOUT THE PATIENT'S CONSENT." } ], "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": "03/19/2012;01/10/2013" } ] }