{ "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": "2955842-2013-04832", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120104", "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": "559376", "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": "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": "20131031", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "92", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Bacterial Infection", "Purulent Discharge", "Fever", "Inflammation", "Nausea", "Perforation", "Pleural Effusion", "Vomiting", "Peritonitis", "Sweating", "Confusion/ Disorientation" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3441266", "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": "11241190", "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 SI SURGICAL PROCEDURE." }, { "mdr_text_key": "3945726", "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, BILATERAL SALPINGO-OOPHORECTOMY, UTEROSACRAL VAGINAL VAULT SUSPENSION AND CYSTOSCOPY PROCEDURE ON (B)(6) 2012 FOR MENORRHAGIA, DYSMENORRHEA AND PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AS WELL AS A POSTOPERATIVE CONSULT REPORT FROM (B)(6) 2012. MULTIPLE LAB REPORTS WERE ALSO INCLUDED. 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. MULTIPLE ADHESIONS OF THE OMENTUM, SIGMOID, EPIPLOICA AND SIGMOID TO THE LEFT PELVIC SIDEWALL AND OVARY WERE NOTED AND TAKEN DOWN, WHICH TOOK APPROXIMATELY 30 MINUTES. THE REMAINDER OF THE PROCEDURE WAS UNEVENTFUL AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT PRESENTED WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING IN THE ER. SHE WAS HALLUCINATING AND SWEATING PROFUSELY. SHE HAD A TENDER ABDOMEN AND FEVER. THE CT SCAN SHOWED A LARGE ABSCESS IN THE PELVIS AND PNEUMOPERITONEUM WITH EXTREME INFLAMMATORY CHANGE IN THE PELVIS. A SURGICAL CONSULT WAS PERFORMED, FOR A POTENTIAL HOLLOW VISCUS PERFORATION. AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND WAS FOLLOWED BY THE DRAINAGE OF > 1L OF PUS FROM A PELVIC ABSCESS. EXTENSIVE ABDOMINAL ADHESIONS DUE TO PERITONITIS AND A SMALL PERFORATION IN THE LOOP WERE NOTED. ON (B)(6) 2012, A CT SCAN SHOWED A NEW TRACE RIGHT PLEURAL EFFUSION WITH MILD ATELECTASIS. FREE AIR DROPLETS WERE FOUND SCATTERED IN THE ABDOMEN AND PELVIS. A NEW RIGHT LOWER QUADRANT ILEOSTOMY WAS SEEN. ON (B)(6) 2012, A CT SCAN SHOWED THE DRAIN IN PROPER POSITION AND SMALL AMOUNTS OF FREE GAS IN THE MID AND ANTERIOR ABDOMEN. FREE FLUID SEEN AND NOTED TO BE UNCHANGED SINCE THE (B)(6) 2012 FINDINGS. ILEOSTOMY WAS INTACT. INTERVENTIONAL RADIOLOGY CONSULT FOR ABSCESS DRAINAGE RECOMMENDED. ON (B)(6) 2012, A CT-GUIDED DRAINAGE OF THE ABSCESSES WAS PERFORMED AND 60CC PUS OBTAINED. ON (B)(6) 2012, A CT SCAN NOTED FISTULOUS COMMUNICATION TO THE LEFT PELVIC ABSCESS. PATIENT HAD AN ELEVATED WHITE CELL COUNT AND SLIGHT WORSENING OF SYMPTOMS, POTENTIALLY FROM CHEMICAL PERITONITIS FROM THE BARIUM RECEIVED. THE PATIENT WAS DISCHARGED TO A SPECIALTY HOSPITAL ON (B)(6) 2012 FOR SKILLED NURSING IN STABLE CONDITION." } ], "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": "" } ] }