{ "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": "2955842-2013-03513", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110308", "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": "459123", "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 A6.0P8", "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": [ "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": "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": "20130912", "sequence_number_treatment": [ "DA VINCI SI SURG INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "128", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Internal Organ Perforation", "Pain" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345882", "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": "3816204", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON AUGUST 16, 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGECTOMY PROCEDURE ON (B)(6) 2011. REPORTEDLY, DURING THE SURGICAL PROCEDURE AN INADVERTENT CYSTOTOMY OCCURRED. THE OPERATIVE REPORT FINDING INDICATED THAT THE PATIENT HAD EXTENSIVE ANTERIOR ABDOMINAL WALL ADHESIONS AND SCARRING. THE PATIENT'S UTERUS WAS FOUND TO BE ENLARGED DUE TO UTERINE FIBROIDS. THE PATIENT ALSO HAD RIGHT AND LEFT OVARIAN FOLLICULAR CYSTS THAT WERE NOT ADJUSTED. REPORTEDLY, THERE WERE ALSO EXTENSIVE FILMY ADHESIONS ALONG THE ANTERIOR ASPECT OF THE BLADDER TO THE ANTERIOR ABDOMINAL WALL. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. THE OP REPORT INDICATED AN INADVERTENT CYSTOTOMY OCCURRED AND WAS REPAIRED INTRA-OPERATIVELY. A CYSTOSCOPY WAS PERFORMED TO CONFIRM THE INTACTNESS OF THE URETERS. THE PATIENT WAS TAKEN TO THE POST-ANESTHESIA CARE UNIT AWAKE AND IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. REPORTEDLY, THE PATIENT UNDERWENT A CYSTOGRAM ON (B)(6) 2011. THE CYSTOGRAM SHOWED THAT THE PATIENT'S BLADDER WAS DISTENDED AND THERE WAS A SMALL OUTPOUCH OF CONTRAST MATERIAL ALONG THE DOME OF THE BLADDER; HOWEVER, THERE WAS NO EVIDENCE OF EXTRAVASATION AND THE BLADDER APPEARED TO BE NORMAL. THE PATIENT TOLERATED THE PROCEDURE WELL. REPORTEDLY, THE PATIENT UNDERWENT A DA VINCI OOPHORECTOMY PROCEDURE ON (B)(6) 2013 DUE TO PELVIC PAIN. THE OP REPORT REGARDING THIS PROCEDURE WAS NOT PROVIDED TO ISI. REPORTEDLY, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM ON (B)(6) 2013 COMPLAINING OF RIGHT FLANK PAIN. A URINE ANALYSIS WAS PERFORMED AND IT WAS CONSISTENT WITH PROBABLE UTERINE TRACT INFECTION. A COMPLETE BLOOD COUNT TEST WAS PERFORMED AND THE RESULTS WERE FOUND TO BE NORMAL. A CT SCAN WAS ALSO PERFORMED. THE FINDINGS WERE NEGATIVE FOR PULMONARY EMBOLISM. THE PATIENT WAS GIVEN ANTIBIOTICS TO TREAT HER CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013." }, { "mdr_text_key": "11198099", "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 INJURY SUSTAINED 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 THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING 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": "" } ] }