{ "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": "2955842-2013-03504", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130304", "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": "20130912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "458840", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20130912", "sequence_number_treatment": [ "DA VINCI SI SURG SYS INSTRUMENTS, ACCESS & ESU." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "40 YR", "patient_sex": "", "patient_weight": "87", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Erythema", "Fever", "Fistula", "Inflammation", "Swelling", "Abnormal Vaginal Discharge" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345272", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "19296916", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI), RECEIVED INFORMATION AND THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY WITH CYSTOSCOPY PROCEDURE ON (B)(6) 2013. THE PATIENT'S PREOPERATIVE DIAGNOSIS INCLUDED BILATERAL PELVIC ENDOMETRIOSIS. ON (B)(6) 2013, THE PATIENT UNDERWENT A FLUOROSCOPY PROCEDURE AND IT WAS DISCOVERED THAT THE PATIENT HAD A PERIRECTAL OR PRESIGMOID MASS DEFORMING THE COLON WITH AN ASSOCIATED RECTOVAGINAL FISTULA. ACCORDING TO THE OPERATIVE (OR) REPORT REGARDING THE SURGERY ON (B)(6) 2013, THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS STATED THAT A CYSTOSCOPY PERFORMED DURING THE PROCEDURE SHOWED NO INJURY TO THE PATIENT'S BLADDER AND BILATERAL URETERAL EFFLUX. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. IT WAS STATED THAT THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ACCORDING TO THE PATIENT'S PROGRESS NOTES DATED (B)(6) 2013, POST-OPERATIVELY THE PATIENT DEVELOPED HIGH FEVERS AND EXPERIENCED ABDOMINAL PAIN. THE PATIENT ALSO NOTICED FECULENT DRAINAGE FROM THE VAGINA. THE PATIENT'S CONDITION WAS TREATED WITH ORAL ANTIBIOTICS. BASED ON THE INFORMATION INDICATED IN THE PROGRESS NOTES, THE PATIENT'S FEVER AND PAIN SUBSIDED AFTER TWO WEEKS. REPORTEDLY, DURING A BARIUM ENEMA PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT HAD A 2MM FISTULA AND WAS APPROXIMATELY 3CM IN LENGTH. THERE WAS A SUGGESTION OF A MASS COMPRESSING ON THE PATIENT'S RECTUM. THE COURSE OF TREATMENT PLAN WAS TO HAVE THE PATIENT UNDERGO AN ABDOMINAL AND PELVIS CT SCAN TO EVALUATE FOR AN ABDOMINAL ABSCESS AND TO CONTINUE TO HAVE THE PATIENT TAKE ORAL ANTIBIOTICS, AND A HIGH FIBER DIET WAS INITIATED. AN ABDOMINAL AND PELVIC CT SCAN ON (B)(6) 2013 SHOWED NO EVIDENCE OF ABSCESS; HOWEVER, THE PATIENT WAS NOTED TO HAVE A RECTOVAGINAL FISTULA. DURING A FOLLOW-UP VISIT ON (B)(6) 2013, THE PATIENT SHOWED SLIGHT IMPROVEMENT. A CT WAS REPORTEDLY PERFORMED AND SHOWED THAT THE PATIENT HAD INFLAMMATION OF THE PELVIS WITH EVIDENCE OF VAGINAL CUFF LEAK. REPORTEDLY, THE PATIENT UNDERWENT A COLONOSCOPY PROCEDURE ON (B)(6) 2013. THE RESULTS SHOWED AN AREA OF MODERATELY BOGGY, CONGESTED AND ERYTHEMATOUS MUCOSAS IN THE RECTO-SIGMOID COLON OVER ABOUT A 3CM SEGMENT. A BIOPSY PERFORMED FOUND THAT THE PATIENT HAD FOCAL COLITIS. NO OTHER MEDICAL RECORDS WERE PROVIDED TO ISI." }, { "mdr_text_key": "19320263", "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 POST-SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ISI HAS CONTACTED RISK MANAGEMENT GROUP AT THE SITE TO GATHER ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATION AFTER UNDERGOING A DA VINCI SI HYSTERECTOMY PROCEDURE. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT." } ], "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": "" } ] }