{ "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": "2955842-2013-04848", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131231", "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": "560302", "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": "20250812", "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, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "51 YR", "patient_sex": "", "patient_weight": "70", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Fever", "Fistula", "Nausea", "Pain", "Urinary Tract Infection", "Weakness", "Discomfort", "Fibrosis" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3441333", "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": "16804065", "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 WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2012 FOR DYSFUNCTIONAL UTERINE BLEEDING AND ENLARGING UTERINE FIBROIDS. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT (OP) AND THE OP REPORT FOR THE FOLLOWING LAPAROTOMY. NO MEDICAL HISTORY WAS PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL CAUTERY AND TRANSECTION OF THE INFUNDIBULOPELVIC VESSELS, THE ROUND LIGAMENTS, AND THE BROAD LIGAMENTS. IT WAS NOTED DURING THE DISSECTION OF THE BLADDER FLAP THAT THERE WAS MINIMAL SCAR TISSUE FROM HER CESAREAN SECTION. THE CARDINAL LIGAMENTS AND UTERINE VESSELS WERE CAUTERIZED WITH PK CAUTERY AND CUT, AND THE COLPOTOMY MADE TO THE LEVEL OF THE KOH BASKET. THE UTERUS WAS REMOVED VAGINALLY AND THE VAGINAL CUFF CLOSED WITH VLOCK SUTURES. SURGERY WAS COMPLETED WITH NO COMPLICATIONS. ON (B)(6) 2013 PATIENT PRESENTED WITH FEELINGS OF WEAKNESS, PERSISTENT PAIN AND NAUSEA AND LOW GRADE TEMPERATURE AND RLQ MILD TENDERNESS. PATIENT WAS STARTED ON LEVAQUIN FOR UTI. ON (B)(6) 2013 THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY TO REPAIR VESICOVAGINAL FISTULA. SURGERY WAS NOTABLE FOR SEVERE RETROPERITONEAL FIBROSIS SECONDARY TO THE FISTULA FORMATION AND EXTENSIVE ABDOMINOPELVIC ADHESIONS OF THE SMALL BOWEL, COLON, OMENTAL AND PERITONEAL ADHESIONS. BILATERAL SALPINGECTOMY WAS PERFORMED FOR PORTION O THE REMAINING TUBES, AND APPENDECTOMY PERFORMED DUE TO EXTENSIVE DISSECTION AND MANIPULATION OF APPENDIX. THE FISTULOUS TRACT INCORPORATED THE VAGINAL CUFF, AND WAS SHARPLY EXCISED FROM BOTH THE BLADDER WALL AND THE VAGINA. PRIMARY REPAIR OF EACH STRUCTURE WAS PERFORMED, THE BLADDER CHECKED FOR LEAKS, AND SEPRAFILM PLACED TO PREVENT ADHESIONS. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2013 THE PATIENT WAS SEEN FOR A POSTOPERATIVE CYSTOGRAM WHICH SHOWED A SMALL CAPACITY BLADDER, BUT NO EVIDENCE OF LEAK. NO FURTHER RECORDS WERE AVAILABLE AFTER THIS DATE." }, { "mdr_text_key": "17046704", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST SURGICAL COMPLICATIONS FOLLOWING 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": "" } ] }