{ "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": "2955842-2013-04880", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20090507", "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": "562563", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "29 YR", "patient_sex": "", "patient_weight": "110", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Cyst(s)", "Hemorrhage/Blood Loss/Bleeding", "Inflammation" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3443087", "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": "3859466", "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 TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE ON (B)(6) 2009 FOR PELVIC PAIN AND ENDOMETRIOSIS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT IN ADDITION TO THE SURGICAL PATHOLOGY REPORT AND VARIOUS LAB RESULTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. UPON INITIAL EXAMINATION OF THE PELVIC CONTENTS IMMEDIATELY FOLLOWING ENDOSCOPE PLACEMENT, THE UTERUS APPEARED TO BE ENLARGED AND A DEFECT IN THE RIGHT CORNEAL REGION WAS NOTED, THROUGH WHICH THE BALLOON WAS VISIBLE. SAID DEFECT WAS CONFIRMED IN THE SURGICAL PATH REPORT. MINIMAL BLOOD LOSS OCCURRED DURING THE PROCEDURE, WHICH THE PATIENT TOLERATED WELL AND WAS TAKEN BACK TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. ON (B)(6) 2009, THE PATIENT PRESENTED WITH PELVIC PAIN AFTER INTERCOURSE. A CT SCAN FOUND A SMALL AMOUNT OF PNEUMOPERITONEUM AND NONSPECIFIC FREE FLUID IN THE PELVIS. A CONFLICTING REPORT FROM THE PHYSICIAN STATES THAT ALTHOUGH SHE TOLD THE ER STAFF THAT SHE HAD INTERCOURSE, IT WAS NOT TRUE. A VAGINAL EVALUATION WAS PERFORMED AND THE CUFF WAS DEEMED INTACT. A LAPAROSCOPIC EXAM NOTED ADHESIONS OF THE SMALL BOWEL AND APPENDIX TO THE VAGINAL CUFF. A LAPAROTOMY WAS PERFORMED. THE CUFF WAS OPENED FOR PLACEMENT OF A DRAIN. THE APPENDIX WAS INFLAMED DUE TO ITS ADHESION TO THE VAGINAL CUFF AND WAS REMOVED. THE PATIENT'S OVARIES AND AN ADHERENT FALLOPIAN TUBE WERE REMOVED. THE OVARIES WERE FOUND TO HAVE FLUID FILLED CORTICAL CYSTS AND A HEMORRHAGIC CYST. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "11241239", "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 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": "" } ] }