{ "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": "2955842-2013-04755", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110620", "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": "20131031", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "559513", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "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 A5.1PP8", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20131031", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES&ES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "51 YR", "patient_sex": "", "patient_weight": "98", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Extravasation", "Fistula", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20131001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3439723", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131001", "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": "11344078", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED BOWL INJURY." }, { "mdr_text_key": "3947178", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION FOR PROSTATE CANCER ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE FOLLOW UP OPERATIONS, BUT NO MEDICAL HISTORY OR IMAGING REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PROSTATECTOMY WAS STARTED WITH EXPOSURE AND SHARP TRANSECTION OF THE BLADDER NECK, FOLLOWED BY DIVISION OF VAS DEFERENS, DISSECTION OF THE SEMINAL VESICLES, AND PROSTATIC PEDICLES. THE LEFT NEUROVASCULAR BUNDLE WAS CLIPPED SECONDARY TO HIGH VOLUME DISEASE ON THE LEFT. THE APEX WAS DISSECTED, DORSAL VENOUS COMPLEX CAUTERIZED AND DIVIDED AND THE URETHRA SHARPLY DIVIDED. IN ADDITION THERE WAS SIGNIFICANT BLEEDING FROM THE BLADDER NECK AND PROSTATIC PEDICLE ON THE LEFT WHICH WAS CONTROLLED WITH SEVERAL SUTURES. THERE WAS NO EVIDENCE OF RECTAL INJURY AT THE TIME PELVIC LYMPH NODES WERE THEN DISSECTED, CLIPPED AND REMOVED TO THE OBTURATOR NERVE. THE URETHRAL/BLADDER NECK ANASTOMOSIS WAS COMPLETED. AFTER COMPLETION THE ANTERIOR BLADDER NECK VESSEL WAS BLEEDING AND REQUIRED CAUTERY. FLOSEAL AND SURGICEL WERE USED TO MAINTAIN HEMOSTASIS AND THE SURGERY CLOSED. THERE WAS REPORT OF AN INTRAOPERATIVE COMPLICATION BEYOND 650ML BLOOD LOSS. ON (B)(6) 2011, PATIENT PRESENTED WITH FECULENT DRAINAGE FROM THE FOLEY CATHETER. CT REVEALED EXTRAVASATION OF CONTRAST FROM THE BLADDER INTO THE RECTUM. ON (B)(6) 2011 PATIENT UNDERWENT LAPAROSCOPIC LOOP COLOSTOMY AND LYSIS OF ADHESIONS FOR A RECTOVESICAL FISTULA. IT WAS NOTED THAT THE LEFT COLON WAS ADHERENT TO THE PELVIC SIDE WALL WITH A LEFT INDIRECT INGUINAL HERNIA WHICH REQUIRED 20 MINUTES OF DISSECTION. THE COLON WAS DIVERTED TO LLQ AND OSTOMY FORMED. THE SURGERY WAS COMPLETED AND PATIENT WAS DISCHARGED ON (B)(6) 2011 WITH COLOSTOMY AND RESOLUTION OF URINE LEAK. ON (B)(6) 2011, PATIENT UNDERWENT LAPAROTOMY FOR TAKE DOWN OF COLOSTOMY, CREATION OF DIVERTIN LOOP ILEOSTOMY, TRANSANAL REPAIR OF RECTOURETHRAL FISTULA FOR A PERSISTENT RECTOURETHRAL FISTULA. THE FISTULOUS TRACT WAS EXCISED, AND THE RECTUM REPAIRED WITH NO EVIDENCE OF NARROWING. ON (B)(6) 2011, THE PATIENT UNDERWENT TRANSPERINEAL REPAIR OF RECTOURETHRAL FISTULA WITH PLACEMENT OF ALLODERM FOR A PERSISTENT RECTOURETHRAL FISTULA. UPON SEPARATION OF THE FISTULA, A PLASTIC VASCULAR CLIP WITH STONES AROUND THE CLIP ON THE WERE FOUND ON THE BLADDER SIDE OF THE RECTOURETHRAL FISTULA. THE FOREIGN MATERIAL WAS EXCISED, AND THE BLADDER REPAIRED WITH OVERSEWING OF ALLODERM OVER THE REPAIR. THE RECTUM WAS THEN REPAIRED. ON (B)(6) 2012, THE PATIENT UNDERWENT DILATION OF URETHRAL STRICTURE AND ILEOSTOMY TAKEDOWN." } ], "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": "" } ] }