{ "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": "2955842-2013-02424", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130703", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110602", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130703", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "304894", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130703", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "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": "20130703", "sequence_number_treatment": [ "DA VINCI SI SURG SYS, INSTRUMENTS, ACCESS & ESU" ], "sequence_number_outcome": [ "Hospitalization", " O", " R" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "78", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20130603", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3205845", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "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": "3697935", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL COMPLAINT INDICATING THAT A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE SUSTAINED BLADDER AND PELVIC WALL INJURIES. REPORTEDLY THE INJURIES SUSTAINED BY THE PATIENT CAUSED A SMALL BOWEL OBSTRUCTION WITH FISTULA." }, { "mdr_text_key": "11079562", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE ATTORNEY REPRESENTING THE SURGEON RESPONDED INDICATING THAT AT THIS TIME THE SURGEON IS UNABLE TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT DUE TO LEGAL CONSTRAINTS. A REVIEW OF THE SITE'S SYSTEM LOG FOR THE REPORTED PROCEDURE DATE FOUND NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURIES SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGATION THAT A PATIENT SUSTAINED INJURIES DURING DA VINCI SURGICAL PROCEDURE. DUE TO THE LIMITED INFORMATION PROVIDED, AT THIS TIME, ISI IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURIES SUSTAINED BY THE PATIENT. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "24207687", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON OCTOBER 2, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PATIENT'S OPERATIVE (OP) REPORT FOR THE PRIMARY SURGICAL PROCEDURE AND HOSPITAL, OFFICE AND RADIOLOGY REPORTS. ACCORDING TO THE PATIENT'S OP REPORT, ON (B)(6) 2011 THE PATIENT UNDERWENT A DA VINCI SI PROSTATECTOMY FOR PROSTATIC ADENOCARCINOMA. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL, OFFICE, AND RADIOLOGY REPORTS THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SI SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION, HOWEVER A HEMO-LOCK CLIP LATER MIGRATED FROM A SITE OF PLACEMENT THROUGH TO ALTERNATE SITE. ON (B)(6) 2011, THE PATIENT PRESENTED WITH SYMPTOMS OF SMALL BOWEL OBSTRUCTION AND POSSIBLE LEAKING ANASTOMOSIS. AN EMERGENCY LAPAROTOMY FAILED TO SHOW COLORECTAL FISTULA. ADHESIONS AND SMALL URINOMA. ON (B)(6) 2011, CYSTOSCOPY WITH EXTRACTION OF HEMOLOCK CLIP FROM BLADDER NECK AND ON (B)(6) 2012 THE COLOSTOMY WAS REVERSED. PATIENT HAD MULTIPLE COMPLAINTS OF RECTAL ITCHING." } ], "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": "11/01/2013" } ] }