{ "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": "2955842-2012-00253", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20120607", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20100114", "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": "20120806", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120607", "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", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": "MS", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20120607", "sequence_number_treatment": [ "DA VINCI S INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "114", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Bacterial Infection", "Emotional Changes", "Fever", "Inflammation", "Pain", "Swelling", "Discomfort", "Injury", "Test Result" ] } ], "distributor_city": "", "date_report": "20130422", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2603935", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130422", "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": "2787786", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON MAY 8, 2012, INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT THAT ALLEGED THE FOLLOWING: ON (B)(6) 2010, A PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE WITH A LEFT SALPINGO-OOPHORECTOMY AT (B)(6). THERE WERE NO RECORDS OF ANY COMPLICATIONS DURING THE SURGERY AND THE PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT EXPERIENCED SEVERE PAIN IN HER LOWER ABDOMEN AND FEVER AND WAS SUBSEQUENTLY RE-ADMITTED TO (B)(6). THE PATIENT WAS IMMEDIATELY STARTED ON TRIPLE INTRAVENOUS ANTIBIOTIC THERAPY INCLUDING ROCEPHIN, GENTAMICIN, AND FAGYL. A DIAGNOSIS OF PELVIC ABSCESS ALONG THE VAGINAL CUFF WAS MADE. SECONDARY TO THIS, THE PATIENT HAD RADIOLOGY TESTS DONE, INCLUDING A CT SCAN OF THE ABDOMEN AND PELVIS WITH ORAL AND INTRAVENOUS CONTRAST, THAT CONFIRMED A LARGE MASS IN THE LEFT LOWER QUADRANT AND PELVIS HAVING INFLAMMATORY-TYPE FEATURES AND CONTAINING AIR MOST SUGGESTIVE OF AN ABSCESS. THE MASS WAS MEASURED TO BE 7.3 X 5.1 CENTIMETERS IN SIZE. THE READING RADIOLOGIST ALSO NOTED THAT THIS COULD ALSO BE A NECROTIC TYPE MASS WHICH COMMUNICATES WITH BOWEL. THE PATIENT WAS NOTED TO HAVE AN ELEVATED WHITE BLOOD CELL COUNT WITH A LEFT SHIFT CONSISTENT WITH SEPSIS. ON (B)(6) 2010, THE DECISION WAS MADE TO PROCEED WITH SURGERY TO EVALUATE THE ABSCESS. FINDING AT SURGERY CONFIRMED A LARGE PELVIC ABSCESS ALONG THE VAGINAL CUFF. A LARGE AMOUNT OF PUS WAS ENCOUNTERED ON MANIPULATING THE BOWEL OVER THE VAGINAL CUFF. ANOTHER SURGEON WAS CALLED IN TO EVALUATE THE COLON AND IT WAS FELT THAT THERE WAS NO DISCRETE BOWEL INJURY. A DRAINAGE TUBE (JP DRAIN) WAS THEN PLACED AFTER A COPIOUS AMOUNT OF IRRIGATION WITH A BACITRACIN SOLUTION. FOLLOWING THE (B)(6) 2010, SURGERY, THE PATIENT DEVELOPED A POST-OPERATIVE ILEUS. HER CULTURES REVEALED A POSITIVE E. COLI BACTERIAL INFECTION SENSITIVE TO LEVAQUIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2010, ON ORAL ANTIBIOTICS. THE PATIENT CONTINUED TO HAVE ABDOMINAL AND PELVIC PAIN AND BOWEL DISCOMFORT AND WAS REFERRED FOR A FOLLOW-UP CT SCAN ON (B)(6) 2010. THE STUDY SHOWED A PERIPHERALLY ENHANCING FLUID COLLECTION WHICH MEASURED APPROXIMATELY 3.6 CM. ON (B)(6) 2010, DUE TO PERSISTING LOWER ABDOMINAL PAIN, THE PATIENT HAD A THIRD CT SCAN DONE WHICH REVEALED A 2.9 CM PERIPHERALLY ENHANCING FLUID COLLECTION SUPERIOR TO THE BLADDER. ON (B)(6) 2010, DUE TO PERSISTENT LEFT LOWER QUADRANT ABDOMINAL PELVIC PAIN AND BLOATING, THE PATIENT HAD AN ADDITIONAL CT SCAN OF THE ABDOMEN AND PELVIS PERFORMED WHICH REVEALED RESIDUAL INFLAMMATORY SCARRING ALONG THE VAGINAL CUFF. THE PATIENT FURTHER ALLEGES THAT DUE TO THE INJURIES SUSTAINED TO HER VAGINAL CUFF AND BOWEL DURING THE DA VINCI S HYSTERECTOMY PROCEDURE, THE PATIENT HAD TO HAVE MULTIPLE ADDITIONAL MEDICAL TESTS AND PHYSICIAN CONSULTATIONS AND HAS SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT INJURY." }, { "mdr_text_key": "9828504", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT FROM THE SURGEON WHO PERFORMED THE DA VINCI S HYSTERECTOMY WITH A LEFT SALPINGO-OOPHORECTOMY PROCEDURE. TO DATE NO RESPONSE HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "15800875", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "17775549", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL RECEIVED A COPY OF THE PATIENT'S OPERATIVE REPORT. REVIEW OF THE PATIENT'S OPERATIVE REPORT FOUND NO INDICATION THAT A MALFUNCTION OF THE SITE'S DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT'S OPERATIVE REPORT INDICATED THAT THE SURGEON NOTED DURING THE SURGICAL PROCEDURE THAT THERE WAS SOME BLEEDING ON THE PATIENT'S LEFT VAGINAL CUFF APEX. THE AFFECTED AREA WAS MADE HEMOSTATIC WITH FIGURE OF EIGHT VICRYL SUTURES. THE AREA WAS COPIOUSLY IRRIGATED WITH WATER AND THE PEDICLES WERE RE-EVALUATED WITH NO FURTHER BLEEDING NOTED. THE OPERATIVE REPORT INDICATED THAT SURGISEAL WAS PLACED ALONG THE VAGINAL CUFF AND ALSO ALONG THE LEFT IP. THE SURGEON IRRIGATED THE AREA AND NO FURTHER BLEEDING WAS NOTED. THE PATIENT WAS CLOSED AND A CYSTOSCOPY WAS PERFORMED AND THERE WERE NO LESIONS TO THE PATIENT'S BLADDER NOTED. THE PATIENT'S URETERS FILLED IN WITH INDIGO CARMEN BILATERALLY WITH NO 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": "01/23/2013;05/19/2013" } ] }