{ "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": "2955842-2013-04883", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120201", "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": "562780", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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 A5.1P7", "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": "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": "20131101", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "60", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Calcium Deposits/Calcification", "Pain", "Abnormal Vaginal Discharge", "Urinary Frequency / Polyuria", "Prolapse" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3443199", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "3860373", "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 ROBOTIC HYSTERECTOMY FOR PELVIC PAIN, PELVIC CONGESTION SYNDROME, BILATERAL OVARIAN CYSTS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. 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. ON (B)(6) 2012, THE PATIENT HAD THE FOLLOWING PROCEDURE LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY WITH DA VINCI ROBOTIC ASSIST. ON (B)(6) 2012, THE PATIENT WENT TO THE ER SINCE THE PATIENT WAS GOING TO THE BATHROOM, WENT TO HAVE A BOWEL MOVEMENT AND THEN AN OBJECT DROPPED OUT OF HER VAGINA. PATIENT WAS IN SEVERE PAIN. GYNECOLOGIC EXAMINATION: VAGINAL AREA REVEALS PROLAPSED OF ABOUT 6 INCHES OF SMALL INTESTINE WITH MESENTERY THROUGH THE VAGINA EXTERNALLY. THE PATIENT HAD THE FOLLOWING PROCEDURE: VAGINAL EXPLORATION, REDUCTION OF BOWEL EVISCERATION, CLOSURE OF VAGINAL CUFF, CYTOSCOPY, INSERTION OF DOUBLE-J STENT OF THE RIGHT URETER. IT WAS NOTED THAT THERE WAS A POSSIBLE URETERAL INJURY. CIEAR EFFLUX OF METHYLENE BLUE WAS SEEN FROM THE LEFT URETERAL ORIFICE BUT NONE FROM THE RIGHT. PLACED STENT W/O RADIOGRAPHIC GUIDANCE. PLAIN FILM-APPEARED TO BE IN GOOD POSITION. A KUB-RIGHT URETERAL STENT IN PLACE. THERE ARE SEVERAL SUBCENTIMETER CALCIFICATIONS PROJECTING OVER THE RIGHT KIDNEY. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WENT IN FOR RIGHT URETERAL STONE. IT WAS NOTED THAT THERE WAS NO STONE IN THE URETER. THE STENT WAS REMOVED. ON (B)(6) 2012, PATIENT WENT TO THE ER SINCE SHE SHE CLAIMED, SOMETHING IS LEAKING OUT OF ME. AN EXAM WAS DONE AND IT WAS NOTED CUFF INTACT, SUTURES EVIDENT. SCANT LIGHTISH VAGINAL DISCHARGE WHICH IS CULTURED. PATIENT WAS DISCHARGED AND WAS TO FOLLOW UP WITH HER GYNECOLOGIST. ON (B)(6) 2012 A CT ABD/PELVIS WAS PERFORMED. THERE WAS NO EVIDENCE OF HYDRONEPHROSIS. A PUNCTUATE CALCULUS REMAINS TOWARDS THE MID TO UPPER POLE OF THE PATIENT'S RIGHT KIDNEY. ON (B)(6) 2012, PATIENT FOLLOWED UP DUE TO RIGHT FLANK PAIN. CT IN (B)(6) SHOWED THE STONE IN THE RIGHT KIDNEY UNCHANGED. NO HYDRONEPHROSIS. HER PAIN HAS PERSISTED. PATIENT ALSO REPORTED URINARY FREQUENCY AND URGENCY. NO CHANGE IN PAIN WITH VISIT TO CHIROPRACTOR. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11254033", "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": "" } ] }