{ "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": "2955842-2013-04768", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20090422", "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": "560392", "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": "20250810", "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": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES&ES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "39 YR", "patient_sex": "", "patient_weight": "57", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cyst(s)", "Pain" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440014", "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": "19589675", "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 TOTAL HYSTERECTOMY FOR MENORRHAGIA AND DYSMENORRHEA PROCEDURE ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND SECONDARY REVISION SURGERY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. AFTER PORT PLACEMENT, THE ROUND LIGAMENTS, UTEROOVARIAN VASCULAR PEDICLES COAGULATED AND DIVIDED. THE BLADDER FLAP WAS CREATED, THE UTERINE ARTERIES COAGULATED AND DIVIDED AND THE COLPOTOMY PERFORMED OVER THE VCARE CUP. THE UTERUS WAS DELIVERED THROUGH THE VAGINA, SMALL BLEEDERS CONTROLLED ON THE VAGINAL CUFF WITH CAUTERY, AND THE VAGINAL CUFF CLOSED WITH POLYSORB AND A LAPRA-TY. A SHEET OF INTERCEED WAS PLACED OVER THE VAGINAL CUFF, AND THE PROCEDURE COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2009, ON A POSTOPERATIVE VISIT PATIENT WAS DOING WELL WITH NO TENDERNESS, AND A WELL HEALED INCISION CITE. ON (B)(6) 2009, PATIENT PRESENTED WITH HISTORY OF PAIN WITH INTERCOURSE SINCE (B)(6) 2009. VAGINAL EXAM SHOWED ABSENT CERVIX, HEALED VAGINAL CUFF, ADNEXAL TENDERNESS. AN U/S WAS RECOMMENDED FOR WORKUP OF PELVIC PAIN. SUBSEQUENT U/S SHOWED OVARIAN MASSES. ON (B)(6) 2009, PATIENT UNDERWENT DAVINCI BILATERAL SALPING-OOPHORECTOMY WITH VAGINAL CUFF REVISION FOR PELVIC PAIN AND OVARIAN CYST. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE URETERS WERE VISUALIZED AND IP LIGAMENTS COAGULATED AND DIVIDED AND THE OVARIES DISSECTED OFF THE SIDEWALLS. THE THIN PERITONEAL MEMBRANE WAS EXCISED OVER THE VAGINAL CUFF AND THE OVARIES REMOVED THROUGH THE VAGINA. THE VAGINAL APEX INCISED WITH SCISSORS TO FRESHEN THE EDGE, AND THE VAGINAL CUFF CLOSED WITH A TWO LAYER MUCOSAL AND FIBROMUSCULAR REPAIR. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2009, A CT IMAGING STUDY OF THE ABDOMEN/PELVIS FOR LLQ PAIN SHOWED POST CHOLECYSTECTOMY CHANGES TO THE COMMON BILE DUCT, AND TRACE FREE FLUID IN THE ABDOMEN WITH NO EVIDENCE OF ABSCESS OR INFLAMMATORY CHANGES. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF IMAGING." }, { "mdr_text_key": "19831393", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED POST -SURGICAL COMPLICATIONS." } ], "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": "" } ] }