{ "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": "2955842-2013-04837", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20121023", "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": "559241", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "brand_name": "DA VINCI S 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": "IS2000, A51P7", "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": [ "Material Separation" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "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 S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "31 YR", "patient_sex": "", "patient_weight": "87", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Cyst(s)", "Fever", "Inflammation", "Dysuria" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3441293", "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": "11341026", "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": "3946223", "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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR SYMPTOMATIC UTERINE FIBROIDS AND PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION, ALTHOUGH IT WAS DIFFICULT TO SEE THE EXTENT OF THE BLADDER DUE TO THE SIZE OF THE UTERINE FIBROID AND ITS DISTORTION OF THE RELEVANT ANATOMY. THE SURGEON ATTEMPTED TO CREATE A BLADDER FLAP AND PUSH THE PERITONEUM AWAY. CAUTERIZATION OF THE UTERINE ARTERIES WAS PERFORMED AND BLANCHING WAS NOTED ON THE UTERUS. THE OPERATIVE REPORT STATED THAT THE URETERS WERE VISUALIZED THROUGHOUT. DUE TO AMBIGUITY IN THE LOCATION OF THE BLADDER, IT WAS FILLED WITH METHYLENE BLUE TO DIFFERENTIATE IT FROM NORMAL PERITONEUM. THE URETERS WERE NOTED TO BE FUNCTIONING AFTER REMOVAL OF THE UTERUS AND CERVIX. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT PRESENTED WITH LEFT SIDE AND LEFT ABDOMINAL PAIN IN ADDITION TO A LOW-GRADE FEVER. SHE WAS HOSPITALIZED WITH A DIAGNOSIS OF PYELONEPHRITIS. A CT SCAN SHOWED MODERATE HYDROURETERONEPHROSIS AND PERINEPHRIC STRAND CHANGES. AN ABSCESS WAS NOTED NEXT TO THE LEFT DISTAL URETER AND EXTRALUMINAL GASS COLLECTION WAS NOTED WITHIN THE PELVIC CUL-DE-SAC. THE URETER WAS NOT VISUALIZED AND WAS NOTED TO BE LIKELY SURGICALLY ABSENT. SHE WAS DISCHARGED IN GOOD CONDITION ON (B)(6) 2012 WITH A FEVER, FOR A TOTAL STAY OF THREE DAYS. ON (B)(6) 2012, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE PLACEMENT OF A LEFT DOUBLE-J STENT. DURING THE CYSTOSCOPY IT WAS NOTED THAT THE VAGINAL CUFF APPEARED TO BE SEPARATED BUT THE SUTURES WERE INTACT. SHE WAS DISCHARGED TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(6) 2012, SHE PRESENTED TO THE ER WITH DYSURIA AND INTENSE LEFT FLANK PAIN. A CT WAS PERFORMED AND FOUND THE PREVIOUS STENT IN THE PROPER LOCATION AND RESOLUTION OF GAS PREVIOUSLY COLLECTED IN THE PELVIS. ON (B)(6) 2013, ANOTHER CT SCAN WAS PERFORMED. IT WAS NOTED THAT THE STENT HAD BEEN REMOVED AND THAT AN ADNEXAL CYST WAS SEEN WHICH WAS NOT PREVIOUSLY NOTED. NO FURTHER INFORMATION WAS PROVIDED." } ], "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": "" } ] }