{ "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": "2955842-2013-03153", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120807", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "410074", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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 A5.1P7", "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" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20130823", "sequence_number_treatment": [ "DA VINCI S INSTRUMENTS, ACCESSORIES AND ESU." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305597", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "15773612", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25TH, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT THAT UNDERWENT A DA VINCI S RADICAL PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2012. THE PATIENT HAD A HISTORY OF PSA WITH SUBSEQUENT DIAGNOSIS OF ADENOCARCINOMA OF THE PROSTATE. DURING THE PATIENT'S POST-OPERATIVE RECOVERY, IT WAS NOTED THAT THE PATIENT HAD RECTAL BLEEDING. A RECTAL EXAMINATION AND PROCTOSCOPY SHOWED THAT THE PATIENT HAD SUSTAINED A SMALL RECTOTOMY. THE PATIENT WAS IMMEDIATELY TAKEN BACK INTO THE OR TO REPAIR THE INJURY. ISI'S REVIEW OF THE PATIENT'S OPERATIVE (OP) REPORT RELATED TO THE PATIENT'S DA VINCI S PROSTATECTOMY PROCEDURE FOUND NO ANOMALIES OCCURRED DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. A GENERAL SURGEON WAS CONSULTED TO REPAIR THE DAMAGE TO THE PATIENT'S RECTUM. THE DAMAGE TO THE PATIENT'S RECTUM WAS REPAIRED USING THE DA VINCI SURGICAL SYSTEM. A TWO LAYERED CLOSURE WAS PERFORMED TO REPAIR THE AFFECTED AREA. THE PATIENT'S RECTUM WAS INSPECTED AFTER THE REPAIR WAS COMPLETED. NO OTHER DAMAGE WAS FOUND. AFTER THE SURGERY WAS COMPLETED, THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. BASED ON THE INFORMATION INDICATED IN THE OP REPORT, THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S DISCHARGE SUMMARY INDICATED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. PRIOR TO THE PATIENT'S RELEASE, THE PATIENT WAS AMBULATING, TOLERATING AN ORAL DIET, HAD POSITIVE BOWEL MOVEMENTS AND FLATUS AND HIS PAIN WAS WELL CONTROLLED. THE PATIENT WAS HEMODYNAMICALLY STABLE, AFEBRILE AND HIS LABS WERE WITHIN NORMAL RANGE. THE PATIENT WAS DISCHARGED HOME WITHOUT COMPLICATION." }, { "mdr_text_key": "15874444", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, OPERATIVE, DISCHARGE AND FOLLOW UP NOTES, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA THE OPERATIVE REPORTS DO NOT CONTAIN ANY REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. BAED ON THE INFORMATION PROVIDED IT WAS DETERMINED THAT THERE WAS NO DIRECT CORRELATION TO THE DA VINCI S PROSTATECTOMY PROCEDURE AND THE POST SURGICAL COMPLICATIONS EXPERIENCED BY THIS PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A RECTAL INJURY DURING A DA VINCI S PROSTATECTOMY PROCEDURE. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT." } ], "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": "" } ] }