{ "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": "2955842-2013-04785", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100708", "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": "560315", "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 A6.0P8", "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": "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": "20131031", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "88", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Pulmonary Embolism", "Adhesion(s)", "Anemia", "Edema", "Fistula", "Laceration(s)", "Blood Loss", "Bowel Perforation", "No Code Available" ] } ], "distributor_city": "", "date_report": "20131001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440310", "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": "3853962", "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 SI RADICAL PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION AND REPAIR OF A RECTAL TEAR FOR ADENOCARCINOMA OF THE PROSTATE ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS. CONSULTATION REPORTS FROM VARIOUS SURGEONS INVOLVED IN HIS SUBSEQUENT CARE ARE ALSO INCLUDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION - A RECTAL TEAR. OPENING DENONVILLIERS' SPACE WAS NOTED TO BE DIFFICULT DUE TO THE PRESENCE OF A PARTICULARLY LARGE, FLOPPY BLADDER. THE BLADDER WAS ADHERED TO THE ANTERIOR ABDOMINAL WALL, WHICH MADE DISSECTION INTO THE SPACE OF RETZIUS PARTICULARLY DIFFICULT. LOCATION OF THE BLADDER NECK REQUIRED FURTHER DISSECTION, AS THE BLADDER WAS CONSTANTLY FLOPPING ON TO THE PROSTATE. SPECIMENS OF THE BLADDER NECK WERE FROZEN TO DETERMINE THE EXTENT OF DISSECTION REQUIRED, AND ADDITIONAL RESECTION WAS REQUIRED UPON RECEIPT OF THE RESULTS. UPON COMPLETION OF SEPARATING THE PROSTATE FROM THE REMAINING DENONVILLER FASCIA, A 1CM RENT WAS NOTED IN THE RECTUM. THIS WAS A RECTAL DIVERTICULUM THAT HAD BEEN ADHERENT TO THE POSTERIOR PORTION OF THE PROSTATE. A 2-LAYER CLOSURE WAS SUBSEQUENTLY PERFORMED. ANOTHER RECTAL DIVERTICULUM WAS NOTED TO BE ADHERENT AND ON REMOVING THE PROSTATE, THIS AREA APPEARED TO AVULSE. THIS WAS CLOSED IN 2 LAYERS. ANOTHER PINPOINT LEAK WAS NOTED UPON COMPLETING THE PROSTATE DISSECTION AND WAS REPAIRED. ANOTHER SURGEON WAS CONSULTED TO VIEW THE RECTAL TEAR REPAIRS UNDER RECTAL INSUFFLATION AND AGREED THAT THE REPAIRS WERE SUFFICIENT. THE PATIENT WAS CLOSED AND TRANSFERRED TO THE RECOVER ROOM IN STABLE CONDITION; 200ML BLOOD LOSS OCCURRED. ON (B)(6) 2010 PATIENT PRESENTED WITH EVIDENCE OF FECAL DRAINAGE AROUND HIS FOLEY CATHETER. ON (B)(6) 2010 A HAND-ASSISTED LAPAROSCOPIC DIVERTING COLOSTOMY WAS PERFORMED IN WHICH LYSIS OF ADHESIONS AND REPAIR OF A SMALL BOWEL AND SEROSAL TEARS OCCURRED. ADHESIONS OF BOWEL TO THE DRAIN FROM THE PRIOR PROCEDURE WERE TAKEN DOWN AND SEROSAL TEARS OCCURRED DURING THIS PROCESS, WHICH WERE REPAIRED WITH SUTURE. FOLLOWING THE COLOSTOMY AN ULCER IN THE ANTERIOR ASPECT OF THE RECTUM ABOVE THE SPHINCTER COMPLEX WAS FOUND. THE URETHROVESICAL ANASTOMOSIS HAD DEHISCED. THE DECISION WAS MADE TO DISCUSS THE FINDINGS WITH THE PATIENT BEFORE PROCEEDING AND HE WAS WOKEN BEFORE BEING TAKEN TO THE RECOVERY ROOM IN EXCELLENT CONDITION. THE FOLLOWING DAY HE WAS PLACED UNDER ANESTHESIA FOR EVALUATION OF HIS RECTOURETHRAL FISTULA, WHICH WAS OBSERVED TO BE A 5CM X 5CM FISTULA WITH EVIDENCE OF PRIOR SUTURING. CONSERVATIVE MANAGEMENT WAS RECOMMENDED. HE WAS GIVEN 2 UNITS OF RED BLOOD CELLS DUE TO ANEMIA RELATED TO INTRAOPERATIVE BLOOD LOSS AND DISCHARGED TO HOME ON (B)(6) 2010 IN STABLE CONDITION. ON (B)(6) 2010 THE PATIENT WAS ADMITTED TO THE ER WITH LEFT LOWER LEG EDEMA AND WAS FOUND TO HAVE BILATERAL DEEP VEIN THROMBOSIS AS WELL AS BILATERAL PULMONARY EMBOLISM. HE WAS PLACED ON ANTICOAGULANTS AFTER A VASCULAR SURGEON RECOMMENDED AGAINST PLACEMENT OF AN INFERIOR VENA CAVA FILTER. HE WAS DISCHARGE ON (B)(6) 2010 IN STABLE CONDITION. NO FURTHER INFORMATION WAS PROVIDED AFTER THIS DISCHARGE." }, { "mdr_text_key": "11449939", "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 POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED A BOWEL INJURY WHILE UNDERGOING A DA VINCI SI RADICAL PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION FOR ADENOCARCINOMA OF THE PROSTATE." } ], "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": "" } ] }