{ "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": "2955842-2013-05005", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131103", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120427", "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", "User facility" ], "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": "565545", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131103", "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": "DA", "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": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20131103", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "45 YR", "patient_sex": "", "patient_weight": "86", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Shock", "Injury", "Loss of consciousness", "Irritability" ] } ], "distributor_city": "", "date_report": "20131024", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444757", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131024", "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": "3861379", "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 PROCEDURE ON (B)(6) 2012 FOR MENORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED SOME OF THE HOSPITAL RECORDS AND DOCUMENTATION REGARDING THE PATIENT INJURIES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS AN INTRAOPERATIVE COMPLICATION. THE OPERATIVE REPORT DETAILED A PELVIC SIDEWALL RENT AND A HEMATOMA, WHICH WAS SUTURED AND OBSERVED AND FELT NOT TO BE EXPANDING. THE HYSTERECTOMY PROCEEDED TO COMPLETION. THE PATIENT PROCEEDED TO RECOVERY WHERE SHE HAD AN EPISODE OF HYPOTENSION, WHICH SEEMED RESPONSIVE TO FLUIDS, 2 UNITS OF PACKED RBC'S, AND VOLUME EXPANDERS. THEN FOR 9 HOURS OR SO, SHE WAS ON THE MEDICAL FLOOR, BUT EVENTUALLY BECAME AGITATED, LOST CONSCIOUSNESS AND WAS FOUND TO HAVE A LOWER THAN EXPECTED HEMOGLOBIN. SHE RETURNED TO THE OPERATING ROOM WHERE SHE WAS FOUND TO HAVE AN INJURY TO THE DISTAL RIGHT ILIAC ARTERY. THIS WAS RETROPERITONEAL AND HAD TO BE REPAIRED BY A VASCULAR TEAM. THE PATIENT SUFFERED A VARIETY OF PROBLEMS RELATED TO REVERSIBLE SHOCK, BUT EVENTUALLY RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL ON DAY 14." }, { "mdr_text_key": "11412141", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A USER FACILITY MEDWATCH (UF/IMPORTER REPORTER (B)(4), DATED (B)(4) 2013). PER THE REPORT, THE SURGICAL STAFF NOTED SOME BLEEDING DURING THE DA VINCI HYSTERECTOMY PROCEDURE. THE SURGEON PLACED A STITCH WHERE THE HEMATOMA WAS AND DECIDED THAT THE PATIENT DID NOT REQUIRE AN OPEN SURGICAL PROCEDURE. THE SURGEON THEN FINISHED THE PROCEDURE AND CHECKED AGAIN FOR BLEEDING AND CHECKED THE HEMATOMA AREA, IT SEEMED THE SAME AND THEN SHE CLOSED. PATIENT WAS TRANSPORTED TO RECOVERY. HOWEVER, IT WAS REPORTED TO US LAST WEEK THAT THIS PATIENT HAD OTHER COMPLICATIONS AND WENT INTO HEMORRHAGIC SHOCK THE MORNING AFTER HER INITIAL SURGERY. AND SHE WAS TAKEN EMERGENTLY FOR AN EXPLORATORY LAPAROTOMY AND WAS FOUND TO HAVE AN INJURY TO HER RIGHT EXTERNAL ILIAC ARTERY. ON (B)(4) 2013, ISI SPOKE WITH THE INITIAL REPORTER OF THE USER FACILITY MEDWATCH. SHE CONFIRMED THERE CURRENTLY DO NOT HAVE ANY REPORTS OF ANY MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY RELATED TO THE REPORTED EVENT; HOWEVER, THEY ARE CURRENTLY CONDUCTING THEIR OWN INVESTIGATION. SHE ALSO PROVIDED THE CORRECT SYSTEM SERIAL USED WITH THE REPORTED EVENT, WHICH HAS BEEN UPDATED. BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS STILL BEING REPORTED SINCE THE PATIENT SUSTAINED POST-SURGICAL COMPLICATIONS FOLLOWING THE DA VINCI HYSTERECTOMY PROCEDURE. CORRECTIONS: SYSTEM SERIAL IS (B)(4)." }, { "mdr_text_key": "11214921", "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": "11/12/2013" } ] }