{ "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": "2955842-2013-03168", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120312", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "409890", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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": "IS 3000 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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Anemia", "Laceration(s)", "Seroma" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305718", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "20860303", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO DEVELOPED POST- SURGICAL COMPLICATIONS AFTER HAVING A DA VINCI SI HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012. IT WAS NOTED THAT A 360 DEGREE CIRCUMFERENTIAL CUTTING OF THE CERVIX FROM THE VAGINA WAS PERFORMED USING MONOPOLAR HOT SHEARS. A SMALL LACERATION WAS DETECTED AT THE VAGINAL CUFF; HOWEVER, THE LACERATION WAS CLOSED WITH SUTURES. THE PELVIS WAS IRRIGATED AND FOUND TO BE COMPLETELY HEMOSTATIC BEFORE THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED HOME ON POST- OPERATIVE DAY ONE. THE PATIENT WENT IN TO THE OFFICE FOR A FOLLOW-UP VISIT ON (B)(6) 2012 AND THE ABDOMINAL INCISIONS WERE DESCRIBED AS HEALING WELL. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2012 WITH COMPLAINTS OF ABDOMINAL PAIN. PATIENT WAS EXAMINED AND A CT SCAN OF THE ABDOMEN AND PELVIS REVEALED A SMALL FLUID COLLECTION IN THE CUL-DE-SAC NEAR THE CUFF WITH A FLECK OF AIR MEASURING 2 CM. DIFFERENTIAL DIAGNOSES INCLUDE A SMALL ABSCESS OR SEROMA. THE PATIENT SUBSEQUENTLY SAW ANOTHER SURGEON ON (B)(6) 2012 AND HIS EXAMINATION REVEALED AN EXTREMELY TENDER VAGINAL CUFF, AND SURGEON ADMITTED HER TO THE HOSPITAL WITH SUSPECTED VAGINAL CUFF ABSCESS. LABORATORY WORK DURING THE ADMISSION WAS SIGNIFICANT FOR ANEMIA AND LEUKOCYTOSIS (ELEVATED WHITE BLOOD COUNT). THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND WAS DISCHARGED ON (B)(6) 2012 ON ORAL ANTIBIOTICS. THE PATIENT'S DISCHARGE DIAGNOSIS ALSO INCLUDED VAGINAL CUFF ABSCESS. AS OF (B)(6) 2012 THE ABSCESS/CELLULITIS WAS RESOLVED. THE LAST NOTED VISIT WAS ON (B)(6) 2013 AT WHICH TIME ESTROGEN HORMONE TREATMENT WAS INITIATED FOR PERI/POST MENOPAUSAL SYMPTOMS. IT WAS ALSO NOTED THAT THE PATIENT HAD VULVOVAGINITIS AND WAS TREATED WITH AN ANTIBIOTIC." }, { "mdr_text_key": "21135917", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW -UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THE PATIENT'S CONDITION RESOLVED WITH ANTIBIOTIC THERAPY WITHOUT THE NEED FOR ANY ADDITIONAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUFFERED AN ABSCESS AFTER A DA VINCI SI HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY PROCEDURE. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." } ], "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": "" } ] }