{ "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": "2955842-2013-04976", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20100223", "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": "562252", "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", "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": "20250806", "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": [ "Hospitalization", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Incontinence", "Pain", "Discomfort" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444363", "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": "3900230", "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 HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY, ADHESIOLYSIS, AND REPAIR OF VAGINAL WALL LACERATION PROCEDURE ON (B)(4) 2010 FOR AN ENLARGED FIBROID UTERUS, ANEMIA, PERSISTENT OVARIAN CYST, AND CHRONIC PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES AN UNDATED OPERATIVE REPORT OF A FISTULA REPAIR, A PATHOLOGY REPORT FROM (B)(6) 2010, AND OFFICE NOTES FROM THE PRIMARY SURGEON DOCUMENTING THE PATIENT'S RECOVERY ON (B)(6) 2010. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. ACCORDING TO THE DA VINCI SURGICAL PROCEDURE OPERATIVE REPORT, THE PATIENT WAS NOTED TO HAVE A UTERUS THAT WAS ENLARGED, IRREGULAR, FIRM CONSISTENCY, AND HAD FIBROIDS. BOWEL ADHESIONS TO ANTERIOR ABDOMINAL WALL ON RIGHT WERE NOT IN DIRECT FIELD OF OPERATION; THEY WERE MORE LATERAL. ADHESIONS ON LEFT SIDE WERE LYSED TO GET BOWEL AWAY FROM INFUNDIBULOPELVIC LIGAMENTS. ON CONTRALATERAL SIDE, THE SURGEON LOOKED TO SEE IF MORE ROOM TO MANEUVER THE BULKY UTERUS AND NOTED IT WAS DIFFICULT TO SEE THE END TO DEVELOP BLADDER FLAP. ON CONTRALATERAL SIDE, IT WAS DIFFICULT TO ACCESS POSTERIOR STRUCTURES DUE TO A LARGE FIBROID IN ANTERIOR RIGHT BROAD LIGAMENT. THE SURGEON STARTED DISSECTION RIGHT BELOW THE RIGHT ROUND LIGAMENT. STARTED RIGHT BLADDER FLAP; FIBROID INHIBITED; REMOVED FIBROID TO BETTER ACCESS ANATOMY. THERE WAS DIFFICULTY RETRIEVING THE UTERUS DUE TO THE BULKINESS AND FIBROID. MONOPOLAR CAUTERY WAS USED TO CUT A SEGMENT OF FUNDUS OFF, TO FIT UTERUS AND ALL PIECES OUT SEPARATELY. THERE WAS A SMALL LACERATION AT POSTERIOR FOURCHETTE AND POSTERIOR VAGINAL WALL RECURRED WHILE TRYING TO EXTRACT THE SPECIMEN VAGINALLY. AN UNDATED AND INCOMPLETE OPERATIVE REPORT, POSSIBLY (B)(6) 2010, NOTED THAT THE PATIENT'S VESICOVAGINAL FISTULA WAS EXCISED. ON (B)(6) 2010, AN OFFICE VISIT NOTE INDICATED THAT THE PATIENT DEVELOPED LEAKING URINE FROM BLADDER SECOND POST-OP WEEK; A VESICO-VAGINA FISTULA WAS DISCOVERED. ACCORDING TO A (B)(6) 2010 DOCTOR'S LETTER, THE PATIENT COMPLAINED OF MILD DYSPAREUNIA SECONDARY TO ESTROGEN DEFICIENCY IN THE VAGINAL MUCOSA. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT CONTINUES TO HAVE SOME DISCOMFORT." }, { "mdr_text_key": "11245344", "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 PATIENT UNDERWENT A DA VINCI HYSTERECTOMY FOR UTERINE FIBROIDS COMPLICATED BY DEVELOPMENT OF VESICOVAGINAL FISTULA 2 WEEKS AFTER HYSTERECTOMY. THIS WAS REPAIRED ADEQUATELY VIA LAPAROTOMY. OF NOTE, THE SURGEON DESCRIBED A RIGHT ANTERIOR FIBROID TUMOR NEAR THE BLADDER THAT WAS REMOVED FROM THE SPECIMEN TO FACILITATE FURTHER DISSECTION. THIS WAS DONE WITH CAUTERY. THE USE OF CAUTERY IN THIS AREA FOR THIS PURPOSE MAY HAVE BEEN THE ROOT CAUSE OF INJURY TO THE BLADDER. 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 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": "" } ] }