{ "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": "2955842-2013-04767", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120312", "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": "560535", "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": "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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 S SYSTEM INSTRUMENTS AND ACCESSORIES&ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "67 YR", "patient_sex": "", "patient_weight": "109", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Adhesion(s)", "Fistula", "Hemorrhage/Blood Loss/Bleeding", "Inflammation", "Necrosis", "Urinary Retention", "Vomiting", "Injury", "Abdominal Distention", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3439989", "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": "3898616", "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 UNDERWENT A DAVINCI PROSTATECTOMY AND EXTENSIVE LYSIS OF ADHESIONS FOR ADENOCARCINOMA IN WHICH 1000ML OF BLOOD LOSS WHICH OCCURRED ON (B)(6) 2012 . INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. UPON INSERTION OF THE ENDOSCOPE, MULTIPLE LOOPS OF BOWEL WERE NOTED TO BE ADHERED TO THE POSTERIOR ABDOMINAL WALL. MULTIPLE ADHESIONS WERE TAKEN DOWN WITH LAPAROSCOPIC SHEARS PRIOR TO ROBOT DOCKING. AFTER DOCKING, MUCH FAT WAS NOTED IN THE ENDOPELVIC FASCIA SURFACE. EXCISING THE BLADDER NEXT ADJACENT TO THE MEDIAN LOBE OF THE PROSTATE WAS A VERY CHALLENGING PORTION OF THE PROCEDURE DUE TO THE SIZE OF THE PROSTATE MEDIAN LOBE. BLADDER NECK RECONSTRUCTION WAS ALSO PARTICULARLY CHALLENGING AND IT WAS NOTED THAT THE ENTIRE SURGERY REQUIRED MUCH MORE SKILL THAN THE NORMAL PROSTATECTOMIES PERFORMED AT THIS INSTITUTION. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6), THE PATIENT PRESENTED WITH SEVERE ABDOMINAL PAIN, DISTENTION, VOMITING AND LOW URINARY OUTPUT. ON (B)(6) 2012, AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND ADHESIONS WERE LYSED. EXTENSIVE ADHESIONS WERE ENCOUNTERED. IN THE PROXIMAL TO MID-ILEUM, A SMALL BOWEL PERFORATION WAS ENCOUNTERED. SIGNIFICANT INFLAMMATORY RESPONSE WAS NOTED, AND SINCE THE BOWEL WAS NOT DEEMED HEALTHY ENOUGH FOR AN ANASTOMOSIS, AN ILEOSTOMY WAS PERFORMED. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE, WHERE HE REMAINED UNTIL EXPERIENCING A MASSIVE INTERNAL HEMORRHAGE. HE WAS THEN PLACED ON A VENTILATOR. A MAG3 RENAL SCAN REVEALED ACUTE TUBULAR NECROSIS AND ACUTE KIDNEY INJURY. THE PATIENT WAS EVENTUALLY TRANSFERRED TO A LONG-TERM CARE FACILITY. ON (B)(6) 2012, A TRACHEOSTOMY WAS PERFORMED. IT WAS REMOVED AND REPLACED ON (B)(6) 2012 DUE TO SIGNIFICANT BLEEDING. ON (B)(6) 2012, THE PATIENT WAS TREATED FOR BLADDER NECK CONTRACTURE WITH A TRANSURETHRAL INCISION OF THE CONTRACTURE AND THEN DISCHARGED HOME IN STABLE CONDITION. ON (B)(6) 2013 THE PATIENT UNDERWENT A CT SCAN WHICH REVEALED A FAILING AV FISTULA. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "11343195", "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 POST- 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 POST -SURGICAL COMPLICATIONS." } ], "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": "" } ] }