{ "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": "2955842-2013-03524", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K021036", "date_of_event": "20111229", "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": "20130913", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "458856", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "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": "IS1200 A4.3P9", "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": "20250804", "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 SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "58", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Hemorrhage/Blood Loss/Bleeding", "Pain" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3346171", "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": "3865962", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGECTOMY PROCEDURE ON (B)(6) 2011. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF A LARGE, SUBSEROSAL UTERINE FIBROID, DYSPAREUNIA, AND MENORRHAGIA. THE RISKS OF SURGERY WERE DISCUSSED WITH THE PATIENT, INCLUDING OPTIONS OF OPEN AND MINIMALLY INVASIVE SURGERY. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED INTRA-OPERATIVE COMPLICATIONS. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE SURGEON STATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD NORMAL FOLLOW-UP POSTOPERATIVE EXAMINATIONS ON (B)(6) 2012. PHYSICAL EXAM DESCRIBES THE VAGINA AS WELL-SUPPORTED AND COMPLETELY HEALED, WITHOUT ANY MASSES OR GRANULATION TISSUE. NO TENDERNESS WAS ELICITED. ON (B)(6) 2012, THE PATIENT PRESENTED TO HER GYN'S OFFICE AS A FOLLOW-UP FROM AN EMERGENCY ROOM (ER) VISIT THE PREVIOUS NIGHT. THE MEDICAL RECORDS FOR THE ER VISIT WERE NOT PROVIDED. ACCORDING TO THE GYN SURGEON'S CLINIC NOTES, THE PATIENT SAID SHE FELT SOMETHING HANGING DOWN FROM HER VAGINA, AND HAD BLEEDING AND PAIN AFTER HAVING INTERCOURSE SO SHE WENT TO THE ER. ACCORDING TO THE PATIENT, THE ER TOLD HER TO FOLLOW UP WITH HER GYN DOCTOR. THE CLINIC NOTES DESCRIBE A STERILE SPECULUM EXAM WHICH SHOWED PART OF THE INTESTINAL EPIPLOICA SEEN IN THE TOP OF THE VAGINA, WITHOUT STRANGULATION OR EVIDENCE OF BOWEL DAMAGE. THAT SAME DAY, THE PATIENT UNDERWENT TRANSVAGINAL SURGICAL REPAIR OF VAGINAL DEHISCENCE. SHE WAS DISCHARGED HOME THE NEXT DAY ON (B)(6) 2012. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT HAD NORMAL POST-OPERATIVE EXAMINATIONS ON (B)(6) 2012. NO POST-OPERATIVE COMPLICATIONS WERE NOTED." }, { "mdr_text_key": "11093318", "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. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT 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 ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED VAGINAL DEHISCENCE AFTER UNDERGOING A DA VINCI HYSTERECTOMY." } ], "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": "" } ] }