{ "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": "2955842-2016-00082", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160206", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20151012", "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": [ "CONSUMER", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160206", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "72691", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160206", "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", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20160206", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Incontinence", "Fistula", "Incontinence" ] } ], "distributor_city": "", "date_report": "20160106", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5414696", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160106", "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": "37617538", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. ISI HAS MADE SEVERAL ATTEMPTS 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. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT CLAIMED THAT SHE REQUIRED A SUBSEQUENT UNPLANNED SURGICAL PROCEDURE TO HAVE A URETERAL STENT PLACED. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "37617539", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 01/06/2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5058365 WITH THE FOLLOWING EVENT DESCRIPTION: AFTER ROBOTIC HYSTERECTOMY, I AWAKENED IN A PUDDLE OF CLEAR LIQUID, THE LEAKAGE WAS SO SEVERE THAT I HAD TO WEAR SUPER ABSORBENT DIAPERS; THE DIAPERS NEEDED TO BE CHANGED AT LEAST 10 TIMES A DAY. I DEVELOPED RIGHT KIDNEY BLOCKAGE, HYDRONEPHROSIS, A URETEROVAGINAL FISTULA, AND URINARY INCONTINENCE. IT WAS DISCOVERED THAT MY URETER HAD BEEN SOWN IN THE VAGINAL CUFF. A SECOND SURGERY WAS REQUIRED TO PLACE A STENT IN MY KIDNEY. MORE SURGERY WILL BE NEEDED IN 6 WEEKS. WHETHER OR NOT MY KIDNEY WILL FUNCTION PROPERLY AGAIN IS STILL UNKNOWN. ON (B)(6) 2016, ISI CONTACTED THE PATIENT AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2015 WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. IN ADDITION, THERE WERE NO REPORTED ISSUES WITH THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2015, THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE AT A DIFFERENT HOSPITAL TO HAVE A STENT PLACED. ACCORDING TO THE SURGEON WHO PLACED THE STENT, HER URETER HAD BEEN SEWN IN THE VAGINAL CUFF AND THERE WAS A HOLE BETWEEN HER BLADDER AND VAGINA. THE SURGEON INDICATED THAT SHE WOULD BE UNDERGOING ANOTHER PROCEDURE IN THE NEAR FUTURE TO REMOVE THE STENT AND TO ASSESS THE CURRENT STATUS OF THE URETER. THE PATIENT STATED THAT SHE SPOKE TO THE SURGEON WHO PERFORMED THE DA VINCI HYSTERECTOMY PROCEDURE BUT THE SURGEON DID NOT DO ANYTHING FOR HER IN REGARDS TO THE POST-OPERATIVE COMPLICATIONS." } ], "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": "" } ] }