{ "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": "2955842-2013-03160", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20090217", "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": "410262", "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": "IS2000", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250826", "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 SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "41 YR", "patient_sex": "", "patient_weight": "75", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Nausea", "Pain", "Injury", "Organ Dehiscence" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305640", "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": "3709535", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25TH, 2013 INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2009. THE PATIENT'S MEDICAL HISTORY SUMMARY WAS PROVIDED. THE INFORMATION RECEIVED STATED THAT DURING THE SURGICAL PROCEDURE, A FAILURE OF THE THREE-DIMENSIONAL OPTICAL SYSTEM OCCURRED WHILE THE SURGEON WAS SUTURING THE VAGINAL CUFF AND THE PATIENT SUSTAINED A VAGINAL CUFF DEHISCENCE. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT UNDERWENT THE DA VINCI SI HYSTERECTOMY ON (B)(6) 2009 FOR CHRONIC ABDOMINAL PAIN, CHRONIC MENOMETRORRHAGIA, CHRONIC PELVIC PAIN, DYSMENORRHEA, AND SYMPTOMATIC LEIOMYOMA. THE MEDICAL SUMMARY INDICATES THAT EQUIPMENT FAILURE OCCURRED PRESUMED DIGITIZER ON THE LEFT 3D EYE SYSTEM ON THE CONSOLE AT THE POINT OF SUTURING. BOTH 2D AND 3D VISUAL SYSTEMS WERE THEN UTILIZED TO COMPLETE THE CASE IN A VERY SAFE MANNER WITHOUT COMPLICATIONS TO THE PATIENT. THE PATIENT EXPERIENCED POST-OPERATIVE NAUSEA FOR 2 DAYS BEFORE SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2009. THE PATIENT INDICATED THAT SHE WAS SENSITIVE TO NARCOTIC MEDICATIONS AND THAT THEY PRODUCE NAUSEA. BY THE SECOND DAY POST OP THE PATIENT REACHED ALMOST COMPLETE RESOLUTION OF NAUSEA, THE PATIENT WAS AMBULATING, TOLERATING DIET, AND WAS DISCHARGED HOME. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT MISSED HER SIX-WEEK POST-OPERATIVE APPOINTMENT. HOWEVER, ON (B)(6) 2009, THE PATIENT REPORTEDLY DEVELOPED SUDDEN ONSET RIGHT LOWER QUADRANT PAIN WHILE WALKING. THE PATIENT WAS SEEN IN AN EMERGENCY ROOM (ER) AND ADMITTED TO A HOSPITAL ON (B)(6) 2009. ON (B)(6) 2009, THE PATIENT UNDERWENT A PROCTOSCOPY AND EXPLORATORY LAPAROTOMY FOR CLOSURE OF VAGINAL CUFF AND DRAINAGE. DURING THE SURGICAL PROCEDURE IT WAS NOTED THAT THERE WAS A WIDE OPENED HOLE IN THE VAGINAL CUFF THAT EVIDENTLY HAD BEEN PLUGGED BY OMENTUM INITIALLY. THE OPERATIVE REPORT STATES THAT ONCE THE OMENTUM HAD BEEN REMOVED AND THE DEFECT EXPOSED THEN IRRIGATED THE PELVIS OUT THOROUGHLY, MADE SURE THAT THE BLADDER FLAP WERE PUSHED ANTERIORLY AND THE VAGINAL CUFF WITH FIVE 1 VICRYL POP OFF SUTURES. THE MEDICAL SUMMARY NOTED THAT THE SURGEON MADE A NICE REPAIR WITH NO OBVIOUS VISCERAL INJURY. THE MEDICAL HISTORY STATES THAT BLOOD LOSS WAS MINIMAL AND THE PATIENT WAS RETURNED TO HER ROOM IN STABLE CONDITION AT THE CONCLUSION OF THE SURGICAL PROCEDURE. THE PATIENT DID WELL POST OPERATIVELY AND WAS DISCHARGED ON (B)(6) 2009." }, { "mdr_text_key": "11011947", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL 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. 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. BASED ON THE OPERATIVE REPORT, IT IS UNKNOWN AT WHAT POINT THE EQUIPMENT FAILURE OCCURRED DURING THE SURGICAL PROCEDURE. IT IS UNKNOWN IF THE EQUIPMENT FAILURE OCCURRED DURING SUTURING OF THE VAGINAL CUFF OR AT THE CONCLUSION OF THE SURGICAL PROCEDURE WHEN SUTURES WERE USED TO CLOSE THE SURGIPORTS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED VAGINAL CUFF DEHISCENCE AFTER UNDERGOING A DA VINCI SI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE DA VINCI SI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY." } ], "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": "" } ] }