{ "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": "2955842-2013-03133", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120807", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "410056", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20130823", "sequence_number_treatment": [ "DAV SI SURG SYS, INSTRUMENTS, ACCSS & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "108", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Abdominal Pain", "Abscess", "Diarrhea", "Inflammation", "Pain", "Perforation", "Tachycardia", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305506", "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": "3590622", "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 RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI TRACHELECTOMY PROCEDURE FOR REMOVAL OF HER CERVIX AND ATTACHED UTERINE TISSUE ON (B)(6) 2012. ON (B)(6) 2012 THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF ABDOMINAL PAIN. THE OPERATIVE REPORT REGARDING THE SURGERY ON (B)(6) 2012 INDICATED THAT THE PATIENT UNDERWENT A DA VINCI SI TRACHELECTOMY PROCEDURE WITH EXTENSIVE LYSIS OF ADHESIONS FOR THE MANAGEMENT OF ENDOMETRIAL HYPERPLASIA IN THE PATIENT'S RESIDUAL UTERINE STUMP AFTER A PREVIOUS SUBTOTAL HYSTERECTOMY. BASED ON THE INFORMATION INDICATED IN THE PATIENT'S OP REPORT, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. HEMOSTASIS WAS ACHIEVED AFTER CLOSURE OF THE VAGINAL CUFF WAS COMPLETED. THE INITIAL PATHOLOGICAL EVALUATION OF THE RESIDUAL STUMP SUGGESTED THAT THERE WAS EVIDENCE OF HYPERPLASIA. AFTER THE PROCEDURE WAS COMPLETED, BLOOD WAS MOPPED FROM THE PATIENT'S PELVIS AND HEMOSTASIS WAS ACHIEVED. A VAGINAL EXAMINATION PERFORMED ON THE PATIENT CONFIRMED THAT THE VAGINAL CUFF WAS COMPLETELY CLOSED AND DRY. THE PATIENT'S URINE WAS NOTED TO BE CLEAR. DURING THE PATIENT'S ER EXAMINATION ON (B)(6) 2012 THE PATIENT NOTED INCREASING PAIN AND HAD MULTIPLE EPISODES OF DIARRHEA AND MILD TACHYCARDIA. DURING A CT SCAN IT WAS DISCOVERED THAT THE PATIENT HAD A LARGE AMOUNT OF FREE AIR WITHIN THE ABDOMEN AND PELVIS. THE CT SHOWED THAT THE COLLECTION OF FLUID POSTERIOR TO THE BLADDER MAY HAVE BEEN DUE TO A POST-SURGICAL ABSCESS. THE PATIENT THEN UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE. DURING THE LAPAROTOMY PROCEDURE IT WAS DISCOVERED THAT THE PATIENT HAD EXTENSIVE ABSCESSES IN THE PELVIS WITH FREE STOOL AND INFLAMED PERITONEUM. THE PATIENT'S PELVIS WAS IRRIGATED AND DEBRIDED EXTENSIVELY. INSPECTION OF THE PATIENT'S SIGMOID COLON FOUND THAT THE PATIENT HAD A PERFORATION JUST BELOW THE PERITONEAL REFLECTION AND SECOND PERFORATION WAS MORE PROXIMAL ON THE SIGMOID COLON. A SIGMOID RESECTION WAS PERFORMED TO REPAIR THE DAMAGE TO THE PATIENT'S COLON. AFTER COMPLETION OF THE SIGMOID COLON RESECTION THE PATIENT'S PELVIS WAS EXTENSIVELY IRRIGATED WITH 5 LITERS OF WARM NORMAL SALINE AND THE REMAINING NECROTIC TISSUE WAS DEBRIDED. BACITRACIN IRRIGATION WAS ALSO PERFORMED. AN OSTOMY SITE WAS CREATED AND UPON COMPLETION OF THE OSTOMY, THE PATIENT'S SUBCUTANEOUS TISSUE WAS EXTENSIVELY IRRIGATED AND THEN CLOSED. THE OSTOMY WAS NOTED TO BE PINK AT THE END OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE ICU IN A STABLE FASHION STILL INTUBATED. THE PATIENT WAS TO BE MONITORED OVER NIGHT. ON (B)(6) 2012 THE PATIENT EXPERIENCED UNEXPLAINED VAGINAL BLEEDING. A VAGINAL EXAMINATION PERFORMED ON THE PATIENT WHILE UNDER ANESTHESIA FOUND THAT THE PATIENT HAD A SMALL DEHISCENCE ON THE LEFT SIDE OF THE VAGINAL CUFF. THERE WAS ALSO SOME OOZING FROM THE REMAINING SUTURE LINE, WHICH POSSIBLY OCCURRED DUE TO RECENT USE OF COUMADIN. THE SURGICAL PROCEDURE WAS TECHNICALLY DIFFICULT DUE TO THE PATIENT'S VERY LONG AND NARROW VAGINAL VAULT. THE PATIENT'S VAGINAL CUFF WAS REPAIRED USING SUTURE AND THE REMAINING VAGINAL CUFF WAS OVERSEWN. A SMALL AMOUNT OF OOZING WAS NOTED FROM THE RIGHT ASPECT OF THE INCISION AND THE AFFECTED AREA WAS SUTURED TO CONTROL THE BLEEDING. CAUTERY WAS ALSO APPLIED TO THE MUCOSA WHERE IT HAD BEEN DENUDED. THE VAGINAL CUFF WAS HEMOSTATIC AFTER COMPLETION OF THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE WELL." }, { "mdr_text_key": "11073553", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC., CONTACTED THE SURGEON WHO PERFORMED THE PATIENT'S TRACHELECTOMY PROCEDURE. THE SURGEON INDICATED THAT THE PATIENT HAD CANCER AND EXTENSIVE INTRAABDOMINAL ADHESIONS AND THAT HE WAS VERY CAREFUL WHILE TAKING DOWN THE ADHESIONS. THE SURGEON STATED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGICAL PROCEDURE AND THAT IT WAS HIS BELIEF THAT THE INJURY SUSTAINED BY THE PATIENT WAS DUE TO THE PATIENT'S DIFFICULT ANATOMY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI SURGICAL SI TRACHELECTOMY PROCEDURE. BASED ON THE INFORMATION PROVIDED, IT HAS BEEN DETERMINED THAT THE DA VINCI SI SURGICAL SYSTEM DID NOT MALFUNCTION IN A WAY THAT CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT, BUT RATHER OCCURRED WHILE THE SURGEON WAS PERFORMING THE SURGICAL TASKING OF TAKING DOWN THE PATIENT'S ADHESIONS. UPON REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012, IT WAS FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT." } ], "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": "" } ] }