{ "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": "2026-09-22", "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": "2955842-2013-04844", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130726", "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": "559253", "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": "20250804", "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" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "70", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Fever", "Pain", "Urinary Tract Infection", "Dysuria" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3441317", "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": "11248035", "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 MEDICAL RECORDS 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 SURGICAL PROCEDURE." }, { "mdr_text_key": "3856495", "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 TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY PROCEDURE ON (B)(6) 2012 FOR MENORRHAGIA, DYSMENORRHEA, AND RIGHT OVARIAN CYST. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HANDWRITTEN ER REPORT FROM (B)(6) 2012, DISCHARGE SUMMARY (B)(6) 2012, DOCTORS PROGRESS NOTES FROM (B)(6) 2012, PHYSICIAN'S ORDER FROM (B)(6) 2012. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. SURGERY REVEALED A PRIMARY CYSTO-RECTOCELE, A NORMAL SIZED, QUIET RETROVERTED UTERUS, CYSTIC RIGHT FALLOPIAN TUBE, MILD BOWEL ADHESIONS. AFTER PLACING A V-CARE UTERINE MANIPULATOR TRANSVAGINALLY, A PNEUMOPERITONEUM WAS CREATED WITH THE VERESS NEEDLE AND ADHESIONS WERE TAKEN DOWN WITH MONOPOLAR CAUTERY SHEARS WITHOUT INCIDENT. TUBO-OVARIAN PEDICLES, LATERAL LIGAMENTS, OVARIAN VESSELS AND THE BLADDER FLAP WERE CAUTERIZED WITH A BIPOLAR INSTRUMENT AND TAKEN DOWN WITH MONOPOLAR SHEARS. AFTER COMPLETE MOBILIZATION OF THE UTERUS AND TRANSECTION AT THE CERVIX THE UTERUS WAS DELIVERED TRANSVAGINALLY. SUBSEQUENTLY, BOTH FALLOPIAN TUBES WERE REMOVED AND CLEAR FLUID WAS NOTED WHEN THE RIGHT CYSTIC FALLOPIAN TUBE WAS DETACHED FROM THE PELVIC SIDE WALL. THE VAGINAL CUFF WAS CLOSED USING A QUILLED SUTURE IN A RUNNING NONLOCKING FASHION. AVITENE POWDER WAS PLACED OVER ALL PEDICLES. NO URINARY LEAK WAS OBSERVED. TRANSVAGINAL EXAMINATION SHOWED NO EVIDENCE OF ACTIVE BLEEDING. POSTOPERATIVE COURSE UNEVENTFUL EXCEPT THE URINARY CATHETER THAT WAS CAUSING SIGNIFICANT PAIN SINCE SURGERY AND THE PATIENT CONTINUED TO HAVE URINARY PAIN AFTER CATHETER REMOVAL EVER SINCE. ON (B)(6) 2012, THE PATIENT PRESENTED TO THE ER WITH FEVER, SUPRAPUBIC ABDOMINAL AND PELVIC PAIN,AND DYSURIA SINCE SURGERY. ON PHYSICAL EXAM, THERE WAS SUPRAPUBIC TENDERNESS. A CT ABDOMEN/PELVIS ON (B)(6) 2012 REVEALED A PELVIC FLUID COLLECTION BUT IT WAS FELT THAT THE MAIN CAUSE OF HER PAIN WAS THE URINARY TRACT INFECTION. THE PATIENT HAD CONTINUOUS IMPROVEMENT OF SYMPTOMS UNDER IV ANTIBIOTIC THERAPY AND WAS DISCHARGE HOME ON (B)(6) 2012." } ], "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": "" } ] }