{ "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": "2955842-2013-04870", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101013", "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": "562519", "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": "20250813", "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 S SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "42 YR", "patient_sex": "", "patient_weight": "57", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Edema", "Hemorrhage/Blood Loss/Bleeding", "Pain", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3442789", "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": "3786029", "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 THAT UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL PELVIC LYMPHADENECTOMY FOR INVASIVE ADENOCARCINOMA OF THE CERVIX ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE FOLLOW UP RECONSTRUCTIVE SURGERIES. NO MEDICAL HISTORY WAS AVAILABLE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE RADICAL HYSTERECTOMY WAS PERFORMED IN THE STANDARD MANNER WITH SEQUENTIAL CAUTERIZATION AND DIVISION OF THE FALLOPIAN TUBES, UTERO-OVARIAN LIGAMENTS, UTERINE VESSELS, CARDINAL LIGAMENT AND UTEROSACRAL LIGAMENTS. COLPOTOMY WAS PERFORMED WITH ELECTROCAUTERY AND SHARP DIVISION WITH A 2 CM VAGINAL MARGIN. THE SPECIMEN WAS DELIVERED THROUGH THE VAGINA, AND THE VAGINAL CUFF CLOSED WITH V-LOC SUTURE AND ONE ADDITIONAL 2-0 VICRYL SUTURE. LYMPHADENECTOMY WAS PERFORMED FROM THE COMMON ILIAC VESSELS TO THE DEEP CIRCUMFLEX VEIN AND POSTERIORLY TO THE OBTURATOR NERVE. THE URETERS WERE OBSERVED TO BE PERISTALSING NORMALLY, AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2011, PATIENT PRESENTED WITH PAIN AND BLEEDING FOLLOWING INTERCOURSE. UPON EXAM WAS FOUND TO HAVE A FULL THICKNESS SEPARATION OF THE VAGINAL APEX INVOLVING THE PERITONEUM. THERE WAS SOME EDEMA AT THE VAGINAL CUFF MARGINS, BUT NO EVIDENCE FOR CELLULITIS OR ABSCESS. SHE WAS TAKEN TO THE OPERATING ROOM FOR A VAGINAL CUFF REAPPROXIMATION. THE SURGEON REPORTED BEING ABLE TO EASILY IDENTIFY HEALTHY VAGINAL CUFF WITH EDEMA, BUT NO EVIDENCE OF DEVITALIZED TISSUE. THE CUFF WAS REAPPROXIMATED, AND THERE WERE NO COMPLICATIONS. ON (B)(6) 2012, PATIENT PRESENTED WITH NEW DEHISCENCE AND OMENTUM PROTRUDING FROM THE VAGINA. SHE WAS TAKEN TO THE OPERATING ROOM FOR A VAGINAL CUFF REVISION AND EXCISION OF PROTRUDING OMENTUM. THE RECTUM AND BLADDER WERE BOTH DISSECTED AWAY FROM THE VAGINAL WALL FOR 2 CM MARGIN AND THE CUFF REAPPROXIMATED AND CLOSED IN A PURSE-STRING MANNER WITH PERMANENT PROLENE SUTURE. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2012, PATIENT WAS SEEN FOR POSTOPERATIVE FOLLOWUP WHICH SHOWED THE VAGINA HEALING WELL, BUT BEING SHORTENED TO 5 CM AT REST. ON (B)(6) 2013, PATIENT UNDERWENT EXAMINATION UNDER ANESTHESIA AND VAGINAL CUFF STRENGTH TESTING. THE MARGINS BEGAN SEPARATING UNDER STRETCH, AND A STRENGTHENING SUTURE WAS PLACED. ON (B)(6) 2013, PATIENT UNDERWENT AN EXTENSIVE VAGINOPLASTY WITH CREATION OF A NEOVAGINA WITH A MYOFASCIOCUTENEOUS FLAP. DURING SURGERY IT WAS NOTED THAT THE VAGINA WAS VERY THIN, BUT HAD WELL VASCULARIZED EPITHELIAL TISSUE. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. PATHOLOGY SHOWED THE VAGINAL CUFF EXCISION TO HAVE PATCHY CHRONIC INFLAMMATION AND FIBROSIS WITH NO EVIDENCE OF DYSPLASIA OR CARCINOMA." }, { "mdr_text_key": "11214880", "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. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL 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": "" } ] }