{ "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": "2955842-2013-03138", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120718", "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": "409544", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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": [ "Leak/Splash" ], "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305500", "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": "18586892", "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. 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. 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 SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INADVERTENT CYSTOTOMY DURING THE DA VINCI SI HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "18059268", "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 SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT SUSTAINED AN INJURY TO HER BLADDER DURING THE SURGICAL PROCEDURE. IN REGARDS TO THE DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT'S MEDICAL RECORDS INDICATE THAT DURING CREATION OF THE BLADDER FLAP, IT WAS NOTED THAT THERE WAS A 5 MM INCISION MADE IN THE DOME OF THE BLADDER. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE CYSTOTOMY WAS INADVERTENTLY MADE IN THE DOME OF THE BLADDER. THE SURGEON REQUESTED A UROLOGIST TO THE OR, BUT THE UROLOGIST DECLINED BECAUSE HE WAS NOT FAMILIAR WITH DA VINCI. THE UROLOGIST INSTRUCTED THE SURGEON TO REPAIR THE CYSTOTOMY. PER INSTRUCTIONS GIVEN BY A UROLOGIST VIA AN INTRAOPERATIVE UROLOGY CONSULT, THE SURGEON REPAIRED THE CYSTOTOMY WITH 2 LAYERS OF SUTURES. ACCORDING TO THE OPERATIVE REPORT, AFTER THE REPAIR WAS COMPLETED, THE PATIENT'S BLADDER WAS FILLED WITH 300 ML OF DILUTED INDIGO CARMINE SOLUTION AND THE REPAIR WAS FOUND TO BE WATERTIGHT. TOWARDS THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT'S BLADDER WAS CHECKED AGAIN AND FILLED WITH 300 ML OF DILUTE INDIGO CARMINE SOLUTION. THE OPERATIVE REPORT INDICATED THAT A SMALL LEAK WAS NOTED IN THE PREVIOUS REPAIR. THE SMALL LEAK WAS REPAIRED WITH ADDITIONAL SUTURES. THE REPAIR WAS NOTED TO BE WATERTIGHT WITH NO FURTHER LEAKAGE. THE OPERATIVE REPORTER INDICATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2012 THE PATIENT COMPLAINED OF SEVERE FLANK PAIN. THE PATIENT WAS THEN SEEN BY A UROLOGIST ON AN UNSPECIFIED DATE FOR A POSSIBLE LEFT URETERAL INJURY. THE UROLOGIST'S IMPRESSION WAS MILD NEPHROSIS, PROBABLY SECONDARY TO A POSTOPERATIVE HEMATOMA, BUT NO OBVIOUS EXTRAVASATION AND NO OBVIOUS URETERAL FISTULA OR INJURY. THE UROLOGIST REPORT STATES HE BELIEVES THIS COULD BE BOTH CHRONIC CHANGES AND ACUTE CHANGES. THE PATIENT WAS PLACED ON AN ORAL ANTIBIOTIC FOR 14 DAYS. ON (B)(6) 2012, THE PATIENT WAS SEEN BY ANOTHER UROLOGIST DUE TO INCREASING LEFT FLANK PAIN THAT OCCURRED ON AND OFF SINCE HER HYSTERECTOMY SURGERY. ON (B)(6) 2012 DURING A FOLLOW UP APPOINTMENT THE UROLOGIST ORDERED A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS. THE CT SCAN, X-RAY AND ULTRASOUND REVEALED THAT THE PATIENT HAD A RECTAL MASS. THE PATIENT WAS REFERRED TO AN ONCOLOGIST. ON (B)(6) 2012, THE PATIENT WAS SEEN BY A GYNECOLOGIST FOR PROGRESSIVELY WORSENING PELVIC PAIN AND EVALUATION OF THE RECTAL MASS. THE GYNECOLOGIST'S IMPRESSION WAS A POSSIBLE POST-OPERATIVE STRICTURE OF THE LEFT URETER AND A RECTAL POLYP. ON (B)(6) 2012, THE PATIENT UNDERWENT A COLONOSCOPY. ON (B)(6) 2012 THE PATIENT UNDERWENT A CYSTOURETHROSCOPY AND LEFT RETROGRADE PYELOGRAM FOR A URETERAL STENT PLACEMENT BY A UROLOGIST FOR PERSISTENT LEFT FLANK DISCOMFORT. DURING THE PROCEDURE, THE UROLOGIST FOUND A LEFT URETERAL OBSTRUCTION WITH URETERAL ULCERATION AND NECROTIC MATERIAL, BUT BECAUSE OF THE OBSTRUCTION, HE WAS UNABLE TO PLACE A STENT. THE UROLOGIST INDICATED THAT IT APPEARED THE ULCER SITE REPRESENTED THE SITE OF CYSTOTOMY REPAIR WITH THE ORIGINAL (B)(6) 2012 SURGERY; IT WAS UNCLEAR TO HIM IF THE REPAIR LINE MIGHT HAVE INVOLVED THE URETERAL OPENING THUS RESULTING IN THE ULCER AND OBSTRUCTION. ON AN UNSPECIFIED DATE A RADIOLOGIST WAS ABLE TO SUCCESSFULLY INSERT A PERCUTANEOUS NEPHROSTOMY TUBE INTO AND ACROSS THE LEFT URETERAL ORIFICE TO EFFECTIVELY BRIDGE THE OBSTRUCTED AREA. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, A UROLOGIST INDICATED THAT THE NEPHROSTOMY TUBE HAD BEEN CONVERTED TO AN INDWELLING URETERAL STENT IN (B)(6) 2012. THE MEDICAL RECORDS FOR THE CONVERSION OF THE NEPHROSTOMY TUBE TO AN INDWELLING URETERAL STENT WERE NOT PROVIDED." } ], "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": "" } ] }