{ "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": "2955842-2013-00115", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20130110", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101103", "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": "20130111", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "14481", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130110", "brand_name": "DA VINCI 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": "UNKNOWN", "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": "OH", "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": "20130110", "sequence_number_treatment": [ "DA VINCI SURG SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Emotional Changes", "Fistula", "Unspecified Infection", "Cramp(s)", "Injury", "No Code Available" ] } ], "distributor_city": "", "date_report": "20130118", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2909052", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130807", "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": "10351047", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO PATIENT OR HOSPITAL NAME/CONTACT INFORMATION PROVIDED FOR THE REPORTED EVENT. THEREFORE, A FOLLOW UP ON THE ALLEGED PATIENT'S CONDITION AND EVENT DESCRIPTION COULD NOT BE MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT." }, { "mdr_text_key": "11031753", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON AUGUST 7, 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION INCLUDING THE PATIENT'S MEDICAL RECORDS REGARDING THE REPORTED EVENT. REPORTEDLY, ON (B)(6) 2010 THE PATIENT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE, BILATERAL SAPLING-OOPHORECTOMY AND LYSIS OF ADHESIONS. THE PATIENT ALSO UNDERWENT A CHOLECYSTECTOMY WITH INTRAOPERATIVE CHOLANGIOGRAM PROCEDURE. BASED ON THE INFORMATION PROVIDED IN THE PATIENT'S OPERATIVE (OP) REPORTS, THE SURGICAL PROCEDURES WERE UNREMARKABLE. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES OCCURRED AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE SURGICAL PROCEDURES WERE SUCCESSFULLY COMPLETED. REPORTEDLY THE PATIENT TOLERATED THE SURGICAL PROCEDURES WELL AND WAS AWAKENED AND TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT IN GOOD CONDITION. REPORTEDLY, ON (B)(6) 2010 AN ABDOMINAL AND PELVIS CT SCAN WITH CONTRAST WAS PERFORMED AND IT WAS DISCOVERED THAT THE PATIENT HAD A SIGNIFICANT AMOUNT OF URINE IN HER UPPER VAGINA AND THAT THE PATIENT HAD A FISTULA. ON (B)(6) 2011, THE PATIENT UNDERWENT A CYSTOSCOPIC PLACEMENT OF BILATERAL URETERAL STENTS, VAGINAL REPAIR OF THE VESICOVAGINAL FISTULA AND ENTEROCELE AND AN INTERPOSITION PLACEMENT OF AN OMENTAL FAT PAD. ACCORDING TO THE PATIENT'S OP REPORT, AT THE COMPLETION OF THE PROCEDURE, A CYSTOSCOPY PERFORMED SHOWED THAT THE FISTULA WAS COMPLETELY CLOSED AND SEEMED TO BE COMPLETELY WATER TIGHT, AS THE PATIENT'S BLADDER FILLED AND NO LEAKAGE WAS NOTED. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE PATIENT'S POST-OPERATIVE RECORDS STATED THAT THE PATIENT WAS HEALING WELL. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." }, { "mdr_text_key": "3309298", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ACCORDING TO ALLEGATIONS MADE IN A LAWSUIT, IT WAS REPORTED THAT THE PATIENT SUSTAINED AN INFECTION AND VESICOVAGINAL FISTULA POST A DA VINCI HYSTERECTOMY AND GALL BLADDER PROCEDURE. THE PATIENT CONTINUES TO SUFFER FROM CRAMPING AND BLADDER PROBLEMS. THROUGHOUT THIS TIME PERIOD, THE PATIENT HAS REPORTEDLY BEEN UNABLE TO MAINTAIN NORMAL INTIMATE RELATIONSHIPS AND HAS SUFFERED EMOTIONAL DISTRESS. THE PATIENT HAD TO HAVE ADDED MEDICAL TESTS AND ADDITIONAL SURGERY AND HAS SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT INJURY." }, { "mdr_text_key": "10538471", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL CONTACTED THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF PERTINENT ADDITIONAL INFORMATION IS RECEIVED." } ], "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": "02/16/2013;09/09/2013" } ] }