{ "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": "2955842-2013-03198", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130826", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100915", "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": "20130826", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "417059", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130826", "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, A60.P8", "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": "20250826", "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": "20130826", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "36 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fever", "Inflammation", "Nausea", "Vomiting", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3306723", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "11065911", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL 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 DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, 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 AFTER UNDERGOING A DA VINCI SI SURGICAL HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "3587144", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON 07/25/2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2010 FOR DYSMENORRHEA, MENORRHAGIA, AND DYSPAREUNIA. ACCORDING TO THE OPERATIVE REPORT FOR THE DA VINCI SI SURGICAL PROCEDURE, THE SURGEON FOUND A RETROVERTED FIBROID UTERUS, NO EVIDENCE OF ENDOMETRIOSIS, AND NORMAL APPEARING OVARIES AND APPENDIX. THE REPORT MENTIONED THE USE OF THE BIPOLAR CAUTERY, AND ENDOSHEARS INSTRUMENTS DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT OF ANY DA VINCI SYSTEM OR INSTRUMENT MALFUNCTION OCCURRING DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS WERE NOTED. THE PATIENT WAS SENT HOME POSTOPERATIVE DAY 2. ON (B)(6) 2010 THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ABDOMINAL PAIN. THE MEDICAL RECORD INDICATED THAT THE PATIENT WAS HAVING SEVERE ABDOMINAL PAIN, NAUSEA, VOMITING, FEVER, AND BLOODY STOOL. A CAT SCAN WAS DONE ON THE PELVIS AND ABDOMEN SHOWING FINDINGS CONSISTENT WITH INFLAMMATORY OR INFECTIOUS PROCESS WITHIN THE POST-SURGICAL SITE WITH FLUID COLLECTIONS IN THE LEFT ADNEXAL REGION AND ANTERIOR TO THE VAGINA. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND PAIN MEDICATIONS AND WAS RECOMMENDED TO WAIT 6 WEEKS FOR THE INFLAMMATORY CHANGES TO HEAL BEFORE REPEATING THE SCOPE. ACCORDING TO THE DOCUMENTATION RECEIVED, THE PATIENT WAS HOSPITALIZED FOR 4 DAYS AND WAS HOSPITALIZED AGAIN IN (B)(6) 2013 FOR BOWEL OBSTRUCTION. THE PATIENT'S CURRENT CONDITION WAS NOT PROVIDED." } ], "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": "" } ] }