{ "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": "2955842-2013-03497", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110413", "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": "20130912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "460307", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "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 A6.0P6", "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": "20250813", "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": "20130912", "sequence_number_treatment": [ "DA VINCI SI SURG INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "31 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Diarrhea", "Fever", "Laceration(s)", "Abnormal Vaginal Discharge", "Vomiting", "Abdominal Cramps" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345199", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "3817234", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY AND ABLATION OF ENDOMETRIOSIS PROCEDURE ON (B)(6) 2011. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES OCCURRED OR THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE OP REPORT, AFTER CLOSURE OF THE PATIENT'S VAGINAL CUFF WAS COMPLETED, EXCELLENT HEMOSTASIS WAS NOTED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM (ER) COMPLAINING OF ABDOMINAL PAIN, HAD A FEVER OF 101 AND HAD DRY NON-PRODUCTIVE DRY COUGH. THE PATIENT DENIED ANY ABNORMAL VAGINAL DISCHARGE, VOMITING OR DIARRHEA. REPORTEDLY, A CHEST X-RAY WAS PERFORMED. THE FINDINGS WERE NORMAL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL'S ER ON (B)(6) 2011 COMPLAINING OF RIGHT SIDED PELVIC PAIN AND A SMALL DECREASE IN APPETITE. ACCORDING TO THE ER DOCUMENTATION, THE PATIENT UNDERWENT A PHYSICAL EXAM, LABS AND X-RAYS. THESE WERE ALL FOUND TO BE UNREMARKABLE. THE PATIENT WAS DISCHARGED ON THE SAME DAY. ON (B)(6) 2011 THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF CHRONIC PELVIC PAIN AND CRAMPING FOLLOWING COITUS. REPORTEDLY, DUE TO THE PAIN, THE PATIENT HAD TROUBLE MOVING HER LEGS. REPORTEDLY, DURING A PELVIC EXAMINATION, IT WAS DISCOVERED THAT THE PATIENT HAD A BROWN DISCHARGE AND THE TISSUE OF HER VAGINAL CUFF EXHIBITED GRANULATION. THE PATIENT'S LABS SHOWED THAT HER KOH TEST WAS ESSENTIALLY NEGATIVE. DURING THE PATIENT'S ER HOSPITALIZATION, DEMEROL AND PHENEGAN WERE ADMINISTERED TO THE PATIENT TO CONTROL HER PAIN. REPORTEDLY, THE PATIENT'S PAIN IMPROVED. REPORTEDLY, ON (B)(6) 2011, THE PATIENT PRESENTED TO THE HOSPITAL'S ER COMPLAINING OF ABDOMINAL PAIN DURING COITUS. EXAMINATION OF THE PATIENT FOUND THAT THE PATIENT HAD A VAGINAL CUFF LACERATION. THE PATIENT WAS SCHEDULED TO UNDERGO A SURGICAL PROCEDURE TO REPAIR THE DEFECT. ACCORDING TO THE PATIENT'S OP REPORT DATED (B)(6) 2011, THE PATIENT'S VAGINAL CUFF WAS REPAIRED WITH SUTURE. FOLLOWING THE REPAIR, EXCELLENT HEMOSTASIS WAS NOTED ALONG THE ENTIRE SUTURE LINE. AFTER COMPLETION OF THE PROCEDURE, THE PATIENT WAS TAKEN BACK TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. THE PATIENT'S MEDICAL RECORDS SINCE (B)(6) 2011 WERE NOT PROVIDED TO ISI; THEREFORE, THE PATIENT'S CURRENT CONDITION IS UNKNOWN." }, { "mdr_text_key": "11200571", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED IN THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF POST-OPERATIVE 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. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS POST A DA VINCI SI HYSTERECTOMY 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": "" } ] }