{ "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": "2955842-2013-04935", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20070130", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562156", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": "20250827", "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": "20131101", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Abscess", "Adhesion(s)", "Dehydration", "Encephalopathy", "Fistula", "Neuropathy", "Renal Failure", "Sepsis", "Tissue Damage", "Obstruction/Occlusion", "Test Result" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444181", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "3950785", "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 RETROPUBIC PROSTATECTOMY FOR LOCALIZED PROSTATE CANCER ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS ((B)(6) 2007). ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL: (B)(6) 2007, INFECTIOUS DISEASE CONSULTATION (B)(6) 2007, GENERAL SURGERY CONSULT (B)(6) 2007, PULMONOLOGY CONSULT (B)(6) 2007, HEMATOLOGY CONSULT (B)(6) 2007, NEUROLOGY CONSULT (B)(6) 2007, NEPHROLOGY CONSULT (B)(6) 2007, DISCHARGE SUMMARY (B)(6) 2007 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 ENTERING INTO THE ABDOMEN AND CREATING A PNEUMOPERITONEUM NO SIGNIFICANT ADHESIONS WERE NOTED. SUBSEQUENTLY, A ROUTINE RADICAL PROSTATECTOMY WAS PERFORMED WITHOUT INCREASED DIFFICULTY OR NOTED INJURIES TO ADJACENT STRUCTURES. THE WOUND AREA LOOKED TO HAVE NO APPARENT INJURY TO THE BLADDER OR BOWEL. ON (B)(6) 2007 - THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH EXTENSIVE ADHESIOLYSIS, SMALL BOWEL RESECTION AND REPAIR OF MULTIPLE ENTEROTOMIES. DEBRIDEMENT AND DRAINAGE OF RIGHT-SIDED ABDOMINAL WALL ABSCESS (B)(6) 2007 - THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH SUTURE REPAIR OF SMALL BOWEL AND DEBRIDEMENT OF ANTEROLATERAL ABDOMINAL WALL ABSCESS WITH VICRYL MESH PATCH CLOSURE. ON (B)(6) 2007 - THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH INTUBATION OF ENTEROCUTANEOUS FISTULA, SEPARATION OF THE WOUND AND APPLICATION OF WOUND VAC. HIS POSTOPERATIVE COURSE WAS COMPLICATED BY DEVELOPMENT OF SMALL BOWEL OBSTRUCTION WITH SUBSEQUENT FINDING OF A SMALL BOWEL INJURY AND SUBSEQUENT DEVELOPMENT OF AN ENTEROCUTANEOUS FISTULA. HE WAS FOUND TO HAVE A SMALL BOWEL INJURY AND SPONTANEOUS DRAINAGE OF AN ENTEROCUTANEOUS FISTULA. LOCAL WOUND CARE WAS CARRIED OUT AFTER HE DEVELOPED A BREAKDOWN OF HIS SMALL BOWEL SITE AFTER HIS INITIAL EXPLORATORY LAPAROTOMY. THE PATIENT UNDERWENT SEVERAL EXPLORATIONS OF THIS LOCAL WOUND FOR MANAGEMENT AND DEBRIDEMENT WHICH WAS THEN TREATED WITH A WOUND VAC. HE DEVELOPED ACUTE RENAL FAILURE DUE TO DEHYDRATION SECONDARY TO HIGH-OUTPUT FISTULA WITH SEPSIS, CRITICAL ILLNESS NEUROPATHY, ENCEPHALOPATHY, PANCYTOPENIA SECONDARY MOST LIKELY DUE TO HIS ILLNESS AND PHARMACOMEDICAL TREATMENT. ON (B)(6) 2007, HE IS DISCHARGED HOME WITH LOCAL HOME HEALTH, LOCAL WOUND CARE AND WOUND VAC. THE FOLLOWING PROCEDURES WERE PERFORMED TO CONTROL THE ENTEROCUTANEOUS FISTULA AND WOUND HEALING: ON (B)(6) 2007, CLOSURE OF ENTEROCUTANEOUS FISTULA, CLOSURE OF COMPLEX ABDOMINAL WOUND, FLEXIBLE AND RIGID CYSTOSCOPY WITH STENT PLACEMENT. ON (B)(6) 2007, EXCISION AND DEBRIDEMENT OF A RIGHT LOWER QUADRANT ROOM WITH FURTHER MATURATION OF ENTEROCUTANEOUS FISTULA ON (B)(6) 2007, PARTIAL PANNICULECTOMY WITH MATURATION OF STOMA AND DEBRIDEMENT FOR COMPLEX WOUND OSTOMY IN RLQ. ON (B)(6) 2007, DEBRIDEMENT OF WOUND, TAKE DOWN OF OSTOMY ON (B)(6) 2007, CLOSURE OF ENTEROCUTANEOUS FISTULA WITH LIMITED ADHESIOLYSIS, ALLODERM GRAFT CLOSURE OF ABDOMINAL WALL WOUND WITH ENTEROCUTANEOUS FISTULA." }, { "mdr_text_key": "11213577", "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 EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE." } ], "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": "" } ] }