{ "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": "2955842-2013-04918", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121205", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "561995", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": "20250827", "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 SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "38 YR", "patient_sex": "", "patient_weight": "78", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Bacterial Infection", "Purulent Discharge", "Dyspnea", "Hematoma", "Nausea", "Pleural Effusion", "Renal Failure", "Sepsis", "Discomfort", "Cognitive Changes", "Fluid Discharge", "Test Result", "No Code Available", "Constipation" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444164", "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": "3781363", "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 SI HYSTERECTOMY FOR ABNORMAL UTERINE BLEEDING WITH LARGE UTERINE FIBROIDS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND THE EXPLORATORY LAPAROTOMY AND ICU DISCHARGE SUMMARY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL COAGULATION AND DIVISION OF THE ROUND LIGAMENTS, UTERO-OVARIAN LIGAMENTS, BROAD LIGAMENTS, UTEROSACRAL LIGAMENTS AND UTERINE VESSELS. THE COLPOTOMY WAS COMPLETED, BUT THE UTERUS WAS TOO LARGE TO DELIVER VAGINALLY, SO IT WAS MORCELLATED WITH A HAND HELD MORCELLATOR UNTIL SMALL ENOUGH TO DELIVER. THE VAGINAL CUFF WAS CLOSED WITH V-LOC SUTURE AND ADDITIONAL MATERIAL USED TO SECURE ADEQUATE HEMOSTASIS. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2012, PATIENT PRESENTED WITH A HISTORY OF LOWER ABDOMINAL DISCOMFORT, NAUSEA AND CONSTIPATION. CT IMAGING SHOWED EXTENSIVE COMPLEX FLUID COLLECTION IN PELVIS AND PERICOLIC GUTTERS CONSISTENT WITH HEMATOMA OR ABSCESS. IN THE ED DARK PURULENT MATERIAL WAS DRAINED THROUGH THE VAGINAL CUFF, AND IV ANTIBIOTICS STARTED. ON (B)(6) 2012, FOLLOW UP CT SHOWED CONSOLIDATION OF THE LUNG, INCREASE IN LOCULATED FLUID COLLECTION WITH BUBBLES OF AIR IN THE LEFT PARACOLIC GUTTER AND PERSISTENT FREE AIR. PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS AND DRAINAGE OF ABSCESSES. INTRAOPERATIVELY THE PATIENT WAS NOTED TO HAVE EXTENSIVE LOCULATIONS OF GROSS PURULENCE THROUGHOUT THE ABDOMEN AND A SIGNIFICANT AMOUNT OF HEMATOMA AND PURULENCE AT THE VAGINAL CUFF WHICH WAS FELT TO BE THE ORIGIN OF THE INFECTION. NO OTHER INTRA-ABDOMINAL ABNORMALITY WAS NOTED OTHER THAN THICK EXUDATE ON THE BOWEL AND PERITONEAL SURFACES. POST SURGERY PATIENT BECAME SEPTIC, HAD MENTAL STATUS CHANGES AND DEVELOPED ACUTE KIDNEY INJURY. CULTURES GREW PRIMARILY E.COLI WITH SOME PEPTOSTREPTOCOCCUS TETRADIUS, PEPTOSTREPTOCOCCUS ASACCHAROLYTICUS, AND DIPHTHEROIDS. ON (B)(6) 2012, A RIGHT SIDED THORACENTESIS WAS PERFORMED FOR RIGHT PLEURAL EFFUSION AND SHORTNESS OF BREATH. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED TO A LONG TERM CARE FACILITY FOR A 4 WEEK ANTIBIOTIC TREATMENT AFTER A PROLONGED STAY IN THE ICU DURING WHICH HER SEPSIS WAS TREATED AND RENAL FUNCTION IMPROVED, PATIENT'S MENTAL STATUS IMPROVED AND PATIENT BEGAN TO AMBULATE. SHE WAS DISCHARGED ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "11376664", "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 FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE." } ], "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": "" } ] }