{ "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": "2955842-2013-03174", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20111024", "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": "413413", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI S 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": "IS1200 A51.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": "20250806", "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": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "42 YR", "patient_sex": "", "patient_weight": "69", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hernia", "Organ Dehiscence" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305838", "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": "3833688", "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 RECEIVED INFORMATION OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011 FOR SEVERE CERVICAL DYSPLASIA. THIS PATIENT HAD A FAMILY HISTORY OF OVARIAN CANCER. PRIOR TO THE PROCEDURE, THE PATIENT WAS INFORMED OF THE SURGERY RISKS, INCLUDING CUFF DEHISCENCE, PORT CUFF HEALING. THE PATIENT AGREED AND SIGNED THE CONSENT TO PROCEDURE AND RISKS THEREOF. THE MONOPOLAR SCISSORS INSTRUMENT WAS USED TO TRANSECT THE VAGINAL CUFF FROM THE CERVIX AND WAS DONE IN A CIRCUMFERENTIAL MANNER. THE PATIENT'S ENTIRE CERVIX, UTERUS, TUBES, AND OVARIES WERE REMOVED. THE SURGEON NOTED ACHIEVING EXCELLENT VAGINAL CUFF CLOSURE AFTER SUTURING AS WELL AS APPLYING AN INTERCEED ADHESION BARRIER TO THE CUFF. THE DA VINCI SYSTEM WAS UNDOCKED AND THE PROCEDURE SWITCHED TO TRADITIONAL LAPAROSCOPE FOR THE REMAINDER OF THE PROCEDURE. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT HAD 3 POST-OPERATIVE CHECK-UPS WITH HER DOCTOR FROM (B)(6) 2011. DURING THESE VISITS, HER VAGINAL CUFF WAS NOTED TO BE INTACT AND HEALING WELL. APPROXIMATELY 2 MONTHS AFTER THE DA VINCI SURGICAL PROCEDURE ((B)(6) 2012), THE PATIENT REPORTED A SENSATION FOLLOWED BY VAGINAL BLEEDING DURING SEXUAL INTERCOURSE. SHE WENT TO THE EMERGENCY ROOM (ER) WHERE SHE DIAGNOSED WITH VAGINAL CUFF DEHISCENCE WITH EVISCERATION. ON THE SAME DAY, THE PATIENT UNDERWENT AN EMERGENCY DIAGNOSTIC LAPAROSCOPY AND REPAIR OF VAGINAL CUFF PROCEDURE. THE SURGEON FOUND A SMALL UMBILICAL HERNIA, WHICH WAS REPAIRED. THERE WAS NO EVIDENCE OF BOWEL STRANGULATION OR OTHER DAMAGE. THERE WERE NO APPARENT COMPLICATIONS FROM THE PROCEDURE. THE PATIENT WAS DISCHARGED 2 DAYS LATER ((B)(6) 2012). AS OF (B)(6) 2012, THE PATIENT'S VAGINAL CUFF WAS HEALING WELL AND THE PATIENT HAS NOT REPORTED TO HAVE ANY BLEEDING." }, { "mdr_text_key": "11071659", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) 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. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2011 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL HYSTERECTOMY PROCEDURE WITH BILATERAL SALPINGO-OOPHORECTOMY." } ], "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": "" } ] }