{ "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": "2955842-2013-04798", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130627", "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": "560036", "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": [ "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": "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 SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Extravasation", "Fistula", "Unspecified Infection", "Fluid Discharge" ] } ], "distributor_city": "", "date_report": "20131001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440542", "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": "3901388", "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 TOTAL HYSTERECTOMY, LEFT SALPINGECTOMY, CYSTOSCOPY AND EXTENSIVE LYSIS OF ADHESIONS FOR MENORRHAGIA, FIBROID UTERUS, PELVIC PAIN AND ANEMIA ON (B)(6) 2013. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT, THE REPORT FROM A CT UROGRAM, AND THE PROCEDURE NOTE FOR THE LATER PLACING OF A STENT. DURING THE PRIMARY SURGICAL PROCEDURE, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. THE OPERATIVE NOTE INDICATED THAT THERE WERE EXTENSIVE DENSE ADHESIONS INVOLVING THE ANTERIOR ABDOMINAL WALL, OMENTUM, BOWEL AND RIGHT TUBE AND OVARY (PATIENT HAD H/O RIGHT SALPINGECTOMY). A MONOPOLAR CURVED SCISSORS INSTRUMENT, MARYLAND DISSECTOR INSTRUMENT AND PROGRASP FORCEPS INSTRUMENT WERE USED TO SEQUENTIALLY COAGULATE WITH BIPOLAR AND EXCISE THE ROUND, BROAD AND UTERO-OVARIAN LIGAMENTS. THE COLPOTOMY WAS MADE AGAINST A KOH CUP. SHARP KNIFE MORCELLATION WAS REQUIRED TO REMOVE THE UTERUS THROUGH THE VAGINA, AND IT WAS NOTED THAT THE ENTIRE PROCEDURE WAS EXTREMELY DIFFICULT DUE TO THE EXTREMELY LARGE SIZE OF THE UTERUS AND THE MULTIPLE FIBROIDS. UPON CYSTOSCOPY, BILATERAL JETS WERE NOTED, AND THE SURGICAL INCISIONS WERE CLOSED. THERE WAS NO REPORT OF INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2013, THE PATIENT PRESENTED WITH A HISTORY OF CLEAR FLUID IN HER VAGINA. A CT UROGRAM WAS PERFORMED WHICH SHOWED THE DISTAL RIGHT URETER WAS NOT WELL DEFINED AND THE APPEARANCE OF CONTRAST EXTRAVASATION INTO THE VAGINA. INFECTION COULD NOT BE RULED OUT. ON (B)(6) 2013 THE PATIENT UNDERWENT A CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAM, RIGHT URETERAL STENT PLACEMENT FOR SUSPECTED RIGHT URETEROVAGINAL FISTULA. THE PYELOGRAM CONFIRMED THE EXISTENCE OF THE FISTULA FROM THE DISTAL RIGHT URETER TO THE VAGINA. THE STENT WAS PLACED SUCCESSFULLY WITHOUT COMPLICATION WITH A PLAN FOR DISCHARGE WITH THE STENT IN PLACE FOR 6 WEEKS. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF THE DISCHARGE." }, { "mdr_text_key": "11098814", "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 POST-SURGICAL COMPLICATIONS 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. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS FOLLOWING 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": "" } ] }