{ "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": "2955842-2014-01984", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140407", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20130821", "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": "20140407", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "209358", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140407", "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": "", "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": "", "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": "20140407", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20140306", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3728578", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140306", "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": "18856198", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI PROSTATECTOMY PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A RECTAL PERFORATION. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION: THE DA VINCI PROSTATECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2013. IT IS UNKNOWN IF THE SURGICAL PROCEDURE WAS RECORDED. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTS THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS DURING THE SURGICAL PROCEDURE. THE SURGEON BELIEVED THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. TEN DAYS LATER ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH SYMPTOMS OF URINARY AND FECAL INCONTINENCE. ON (B)(6) 2013, THE PATIENT HAD A FOLLOW-UP VISIT AT THE HOSPITAL AND HAD COMPLAINTS OF INCONTINENCE AND LEAKAGE OF URINE FROM THE URETHRA. THE PATIENT DID NOT RECEIVE ANY TREATMENT DURING THE FOLLOW-UP VISIT. ON (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH A RECTAL PERFORATION. HOWEVER, THE PATIENT DID NOT RECEIVE ANY IMMEDIATE TREATMENT UPON BEING DIAGNOSED WITH THE RECTAL PERFORATION. THE PATIENT'S PROGRESS WAS TO BE OBSERVED WITH PRESERVATION THERAPY. ON (B)(6) 2014, THE PATIENT WAS RE-HOSPITALIZED DUE TO AN UNIMPROVED CONDITION WITH PRESERVATION THERAPY. THE PATIENT UNDERWENT A BALLOON IMPLANTATION PROCEDURE TO STOP REPORTS OF BLEEDING AND TO CLOSE THE BOWEL PERFORATION WITH HIGH PRESSURE BY BALLOON EXPANSION. ON (B)(6) 2014, THE PATIENT UNDERWENT PROCEDURES TO CLOSE THE BOWEL PERFORATION WITH CLIPS USING A COLON FIBERSCOPE AND TO STOP BLEEDING. DUE TO AN UNIMPROVED CONDITION, THE PATIENT UNDERWENT A COLOSTOMY PROCEDURE ON (B)(6) 2014. AS OF (B)(6) 2014, THE PATIENT WAS STILL HOSPITALIZED." }, { "mdr_text_key": "19273675", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND BOWEL INJURY. THERE IS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(4) 2013. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL PERFORATION AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND REQUIRED ADDITIONAL MEDICAL INTERVENTION. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S BOWEL INJURY IS UNKNOWN." } ], "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": "" } ] }