{ "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": "2955842-2013-03517", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120615", "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": "460054", "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": "20250813", "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": "45 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Internal Organ Perforation", "Pain", "Abnormal Vaginal Discharge", "Dysuria" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345924", "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": "3817256", "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 SI TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD AN ENLARGED FIBROID UTERUS, SEVERE DYSMENORRHEA, EXCESSIVE MENSTRUATION OR MENOMETRORRHAGIA, RIGHT LOWER QUADRANT ABDOMINAL PAIN, CHRONIC LOW BACK PAIN AND VAGINAL PRESSURE. AFTER THE PATIENT'S UTERUS WAS REMOVED DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGEON STATED IN THE OPERATIVE REPORT THAT THE VAGINAL CUFF WAS CLOSED USING 2 V-LOCK SUTURES AND WITHOUT DIFFICULTY. INDIGO CARMINE DYE WAS THEN INJECTED INTO AN IV IN ORDER TO ENSURE THAT THE PATIENT'S GENITOURINARY TRACT WAS INTACT. THERE WAS NO INTRAPERITONEAL SPILLAGE OF INDIGO CARMINE DYE AND THE FOLEY CATHETER WAS TINTED BLUE WITH GOOD URINE OUTPUT AT THE END OF THE PROCEDURE. AT THE COMPLETION OF THE PROCEDURE, THE PATIENT WAS SENT TO THE PACU IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY ON (B)(6) 2012. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT BEGAN TO EXPERIENCE LEAKAGE OF FLUID FROM THE VAGINA 1 WEEK POST-OP. ON (B)(6) 2012, THE PATIENT FIRST NOTICED A GUSH OF FLUID AFTER GETTING OUT OF A BATH TUB. SHE ALSO HAD REPORTED COMPLAINTS OF DYSURIA AND SUPRAPUBIC PAIN. THE PATIENT WAS EXAMINED BY A PHYSICIAN ON AN UNSPECIFIED DATE POST-OPERATIVELY AND ALSO ON (B)(6) 2012 FOR COMPLAINTS OF VAGINAL FLUID LEAKAGE. THE PATIENT WAS PRESUMED TO HAVE HAD A UTI AND WAS TREATED WITH CIPRO FOR 5 DAY. IN ADDITION, ON AN UNSPECIFIED DATE POST-OPERATIVELY, ADDITIONAL SUTURES WERE PLACED INTO THE PATIENT'S VAGINAL CUFF. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN THE EMERGENCY ROOM (ER) OF A DIFFERENT HOSPITAL FOR AN UNRESOLVED COMPLAINT OF VAGINAL FLUID LEAKAGE. A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS WITH IV CONTRAST AND A CT CYSTOGRAM REVEALED CONTRAST POOLING INTO THE VAGINA. WITH THE INSERTION OF A SPECULUM, COPIOUS CLEAR YELLOW/TEA COLORED DISCHARGE WAS OBSERVED. UPON DIGITAL EXAMINATION, THE VAGINAL CUFF WAS FOUND TO BE COMPLETELY DEHISCED WITH APPROXIMATELY 3-4 CM AREA OF OPENING/SEPARATION. THERE WAS NO EVIDENCE OF EVISCERATION OR TISSUE PROLAPSING. ON (B)(6) 2012, THE PATIENT UNDERWENT ABDOMINAL REPAIR OF THE VAGINAL CUFF IN ADDITION TO A CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAM, AND CYSTOGRAM. DURING THE PROCEDURE, A RIGHT RETROGRADE PYELOGRAM WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE A URETERAL LEAK. DURING THE PROCEDURE, THE PATIENT ALSO UNDERWENT A RIGHT URETERAL REIMPLANT WITH DOUBLE-J STENT PLACEMENT. AT THE COMPLETION OF THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE SURGEON STATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT'S CONDITION SINCE THEN IS UNKNOWN SINCE NO ADDITIONAL MEDICAL CHARTS WERE PROVIDED TO ISI." }, { "mdr_text_key": "11198984", "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 OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. 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. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED DA VINCI SI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED VAGINAL CUFF DEHISCENCE AFTER UNDERGOING A DA VINCI SI TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY 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": "" } ] }