{ "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": "2955842-2013-04854", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120214", "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": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "559690", "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": "20250806", "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": [ "DAV SI SURG SYS INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Distention", "Bowel Perforation", "Fluid Discharge" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3441356", "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": "3857422", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY WITH EXTENSIVE LAPAROSCOPIC ADHESIOLYSIS AND LAPAROSCOPIC BILATERAL PELVIC LYMPH NODE DISSECTION FOR PROSTATE CANCER ON (B)(6) 2012. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED A FOLLOW-UP REPORT WITH H&P DATED (B)(6) 2012. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGICAL PROCEDURE. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION; HOWEVER, THE SURGERY WAS COMPLICATED BY AN EXTENSIVE AMOUNT OF FLIMSY ADHESIONS OF BOWEL AND OMENTUM OF THE ANTERIOR ABDOMINAL WALL REQUIRING LAPAROSCOPIC ADHESIOLYSIS WITH MONOPOLAR CAUTERY USED SPARINGLY. DURING THE REMAINING DISSECTION THE SPACE BETWEEN THE RECTUM AND PROSTATE WAS DEVELOPED WITHOUT DIFFICULTY; HOWEVER, THERE WAS NOTED TO BE A SIGNIFICANT AMOUNT OF ADHESION LEFT INSIDE, SO WIDE DISSECTION WAS TAKEN USING BIPOLAR CAUTERY ON THE LEFT. THE RIGHT SIDE DID NOT HAVE A SIMILAR AMOUNT OF ADHESION; THEREFORE, NERVE SPARRING WAS ATTEMPTED ON THE RIGHT. A LYMPHADENECTOMY WAS CARRIED OUT IN THE BILATERAL ILEAL-OBTURATOR NODAL AREA, AROUND THE EXTERNAL ILIAC VESSEL VEIN AND THE OBTURATOR NERVE. IN THE END, SURGIFLO AND SURGICEL WAS PLACED IN THE NODAL DISSECTION AREA. POSTOPERATIVELY, THE PATIENT HAD SOME DELAY IN RECOVERY SECONDARY TO BOWEL DISTENTION BUT DISCHARGED HOME AFTER TOLERATING LIQUIDS AND HAVING BOWEL MOVEMENTS. DURING A FOLLOW-UP VISIT ON (B)(6) 2012 THE FOLEY CATHETER WAS REMOVED AFTER A NORMAL CYSTOGRAM WAS PERFORMED AND THE PATIENT'S SUBSEQUENT ATTEMPT TO VOID RESULTED IN VEGETABLE FIBER APPEARING URINE WITH SIGNIFICANT BILIOUS CONTENT CONSISTENT WITH LIKELY SUCCUS. THE PATIENT THEN UNDERWENT CYSTOSCOPY WITH FOLEY CATHETER REPLACEMENT AND WAS READMITTED THE SAME DAY FOR ASSUMED ENTEROVESICAL FISTULA AT THE LEVEL OF THE ANASTOMOSIS. A SAME DAY CT ABDOMEN/PELVIS REVEALED A PELVIC FLUID COLLECTION THAT WAS DRAINED UNDER CT-GUIDANCE. ON (B)(6) 2012 A RELAPAROTOMY WITH 3 HOUR ADHESIOLYSIS, SMALL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS, A RIGID SIGMOIDOSCOPY AND A PARTIAL REPLACEMENT OF THE URETHROVESICAL ANASTOMOSIS WAS PERFORMED AND REVEALED A PERFORATED SMALL BOWEL (1MM ON THE MESENTERIC BORDER) AND AN INTRAABDOMINAL ABSCESS. THE POSTOPERATIVE COURSE WAS COMPLICATED BY NAUSEA AND VOMITING, REQUIRING THE PLACEMENT OF AN NG TUBE AND THE PATIENT DEVELOPED SEPSIS DUE TO A CENTRAL LINE INFECTION REQUIRING ICU TREATMENT. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "11451209", "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 OF THE INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BOWEL INJURY DURING A DA VINCI 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": "" } ] }